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<html> <head> <!DOCTYPE html> <html lang="en"> <title>Medical device & diagnostics</title> <meta charset="UTF-8"> <meta name="description" content="{{description}}"> <meta name="keywords" content="CDSCO, National Regulatory Authority"> <link rel="author" href="https://cdsco.gov.in/opencms/opencms/en/Home/" /> <meta name="description" content="he Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India."> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <script type="text/javascript" src="/opencms/export/system/modules/CDSCO.WEB/resources/js/jquery-3.7.1.min.js"></script> <link rel="stylesheet" type="text/css" href="/opencms/export/system/modules/CDSCO.WEB/resources/css/animate.min.css" /> <link rel="stylesheet" type="text/css" href="/opencms/export/system/modules/CDSCO.WEB/resources/css/owl.theme.css" /> <link 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"><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Drugs-and-Cosmetics-Act/" ><p>Drugs and Cosmetics Act, 1940</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Drugs-Rules/" ><p>Drugs Rules, 1945</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Medical-Devices-Rules/" ><p>Medical Devices Rules, 2017</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/New-Drugs/" ><p>New Drugs and Clinical Trials Rules, 2019</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Cosmetics-Rules/" ><p>Cosmetics Rules, 2020</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Advisories_NO/" ><p>Advisories/Notices/O.Ms./Orders</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Final-Notifications/" ><p>Final Notifications</p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Draft-Notifications/" ><p>Draft Notifications </p></a> <span class="text-center"></span></li><li > <a class="text-decoration-none w-100" href="/opencms/opencms/en/Acts-and-rules/Guidance-documents/" ><p>Guidance documents</p></a> </li></ul><li class="dropdown current-menu-item center"> <a class="text-decoration-none w-100" href="/opencms/opencms/en/bioequi_bioavail/" class="dropdown-toggle" data-toggle="dropdown" ><span class="fa-stacks fa-2s "> <i id="circle" class="fa fa-circle fa-2g "></i> <i class="fa fa-hourglass fa-1x fa-stack-1x bg-orange-head "></i> </span><p>BA/BE</p></a> <ul 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href="#collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-1"> About Medical Devices<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-1" class="panel-collapse collapse " style="height: auto;" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><div><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size">In India, all Medical Devices are regulated under the Drugs & Cosmetics Act, 1940 and Medical Devices Rules, 2017 made thereunder.<br /></span></span></span></div> <div><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"> </span></span></span></div> <div><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"><strong>Medical Devices means -</strong><br /></span></span></span></div> <p class=""><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―</span></span></span><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"><br /></span></span></span></p> <div><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">•</span><span class="x_1590081621colour">       </span><span class="x_1590081621colour">diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;</span></span></span><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"><br /></span></span></span><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">•</span><span class="x_1590081621colour">       </span><span class="x_1590081621colour">diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;</span></span></span><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"><br /></span></span></span><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">•</span><span class="x_1590081621colour">       </span><span class="x_1590081621colour">investigation, replacement or modification or support of the anatomy or of a physiological process;</span></span></span><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"><br /></span></span></span><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">•</span><span class="x_1590081621colour">       </span><span class="x_1590081621colour">supporting or sustaining life;</span></span></span><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"><br /></span></span></span><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">•</span><span class="x_1590081621colour">       </span><span class="x_1590081621colour">disinfection of medical devices; and</span></span></span><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"><br /></span></span></span><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">•</span><span class="x_1590081621colour">       </span><span class="x_1590081621colour">control of conception.</span></span></span><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"><br /></span></span></span></div> <div><span class="x_1590081621colour"><span class="x_1590081621font"><span class="x_1590081621size"> </span></span></span></div> <p class=""><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour"><strong>Risk-based Classification -</strong></span></span></span></p> <div><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">Medical Devices are classified into four class based on the risk parameter </span></span></span><span class="x_1590081621font"><span class="x_1590081621size"><span class="x_1590081621colour">as specified in Part I of the First Schedule of the Medical Devices Rules, 2017, as under:</span><span class="x_1590081621colour"><br /></span></span></span></div> <ol start="2"> <ul> <li> <p><span class="x_1590081621size"><span class="x_1590081621font"><span class="x_1590081621colour">Low risk - Class A;</span><span class="x_1590081621colour"><br /></span></span></span></p> </li> <li> <p><span class="x_1590081621size"><span class="x_1590081621font"><span class="x_1590081621colour">Low moderate risk- Class B;</span><span class="x_1590081621colour"><br /></span></span></span></p> </li> <li> <p><span class="x_1590081621size"><span class="x_1590081621font"><span class="x_1590081621colour">Moderate high risk- Class C;</span><span class="x_1590081621colour"><br /></span></span></span></p> </li> <li> <p><span class="x_1590081621size"><span class="x_1590081621font"><span class="x_1590081621colour">High risk- Class D "</span></span></span></p> </li> </ul> </ol> <p style="text-align: justify;"> </p></div> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000" href="#collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-2"> Functionalities<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-2" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><p style="text-align: justify;"><strong>1.Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices: </strong>A notified body accredited by National Accreditation Body( designated by Central Government) may apply in MD 1 to CLA for grant of registration certificate in MD 2.</p> <p style="text-align: justify;"><strong>2.Grant of Import Licence: </strong>The applicant shall make an application in MD-14 in sugam online portal for grant of import licence in MD-15 to import Medical Devices.</p> <p style="text-align: justify;"><strong>3.Grant of licence or loan licence to manufacture for sale or for distribution: </strong>The applicant shall make an application in MD-7 & MD-8 in sugam online portal for Grant of manufacturing Licence / Loan Licence to Manufacture for Sale or for Distribution of Class C or Class D in MD-9 & MD-10.</p> <p style="text-align: justify;"><strong>4.Grant of test licence to manufacture for test, evaluation, clinical investigations, etc.:</strong>The applicant shall make an application in MD-12 in sugam online portal for licence in MD-13 to manufacture Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.</p> <p style="text-align: justify;"><strong>5.Grant of test licence to import for test, evaluation, clinical investigations, etc.: </strong>The applicant shall make an application in MD-16 in sugam online portal for licence in MD-17 to import Medical Devices for purpose of clinical investigations, test, evaluation, examination, demonstration or training.</p> <p style="text-align: justify;"><strong>6.Grant of license to Import investigational medical device by Government hospital or statutory medical institution for treatment of patient</strong>- Small quantity of investigational medical device, the import of which is not allowed, but approved in the country of origin, may be allowed to be imported by the Central Licensing Authority for treatment of a patient suffering from a life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need, on an application made by a Medical Officer through the medical superintendent of a Government hospital or a statutory medical institution in Form MD-18</p> <p style="text-align: justify;"><strong>7.Permission to conduct clinical investigation of Investigational Medical Device:</strong>The applicant shall make an application in MD-22 in sugam online portal for grant of permission to conduct clinical investigation of investigational medical device in MD-23.</p> <p style="text-align: justify;"><strong>8.Permission to conduct clinical performance evaluation for new in vitro diagnostic medical device:</strong> The applicant shall make an application in MD-24 in sugam online portal for grant of permission to conduct clinical performance evaluation of new in vitro diagnostic medical device in MD-25</p> <p style="text-align: justify;"><strong>9.Permission to import or manufacture medical device which does not have its predicate device – </strong>The applicant shall make an application in MD 26 in sugam online portal after completion of its clinical investigation to the CLA for grant permission to import or manufacture medical device which does not have predicate medical device in Form MD-27.</p> <p style="text-align: justify;"><strong>10.Permission to import or manufacture new in vitro diagnostic medical device:</strong> The applicant shall make an application in MD-28 in sugam online portal for grant of permission to Import or Manufacture for sale or for distribution of new in vitro diagnostic medical device in MD-29.</p> <p style="text-align: justify;"><strong>11.Registration of Medical Device Testing Laboratory</strong>: The applicant shall make an application in MD-39 in sugam online portal for grant of registration in MD-40 to medical device (MD) testing laboratory for test or evaluation on behalf of manufacturer.</p> <p style="text-align: justify;"><strong>12.</strong>Preparation of Guidance and FAQ on key activities.</p> <p style="text-align: justify;"><strong>13.</strong>Processing of application for Issuance of Free Sale Certificate for domestic manufacturers Medical Devices.</p> <p style="text-align: justify;"><strong>14.</strong>Processing of application for Issuance of Market Standing Certificate and Non- Conviction for Medical Devices</p> <p style="text-align: justify;"><strong>15.</strong>Complaint, Not of Standard Quality (NSQ) Verification.</p> <p style="text-align: justify;"><strong>16.</strong>Updating the list as per the Classification of Medical Devices from time to time.</p> <p style="text-align: justify;"><strong>17.</strong>Post Approval Changes in respect of Medical Devices.</p> <p style="text-align: justify;"><strong>18.</strong>Constitution of MD experts committee.</p> <p style="text-align: justify;"><strong>19.</strong>Inspection of manufacturing site for compliance of QMS by CLA/SLA.</p> <p style="text-align: justify;"><strong>20.</strong>Capacity building activities of technical management.</p> <p style="text-align: justify;"><strong>21.</strong>Preparing and submitting replies of Parliament Questions/RTIs/Clarifications/NOCs/ Port office queries</p> <p style="text-align: justify;"><strong>22.</strong>Providing clarification to applicant on the regulatory status of products</p></div> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000" href="#collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-3"> Processes<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-3" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><div class="panel-body"> <ol class="1"> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Approval_process_flowchart_MD_Online1.pdf" target="_blank" rel="noopener noreferrer">Approval process for Application received Online Sugam Portal with respect to Medical Devices.<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Approval_process_flowchart_MD_hardcopy2.pdf" target="_blank" rel="noopener noreferrer">Approval process for Application received in Hard copy with respect to Medical Devices.</a></li> <li>Approved Medical Devices under CLAA <ul> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/CLAA_Year_2010.pdf" target="_blank" rel="noopener noreferrer">2010<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/CLAA_Year_2011.pdf" target="_blank" rel="noopener noreferrer">2011<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/CLAA_Year_2012.pdf" target="_blank" rel="noopener noreferrer">2012<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/CLAA_Year_2013.pdf" target="_blank" rel="noopener noreferrer">2013<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/CLAA_Year_2014.pdf" target="_blank" rel="noopener noreferrer">2014<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/CLAA_Year_2015.pdf" target="_blank" rel="noopener noreferrer">2015<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/CLAA_Year_-2016.pdf" target="_blank" rel="noopener noreferrer">2016<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/CLAA_Year_2017.pdf" target="_blank" rel="noopener noreferrer">2017<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> </ul> </li> <li>Import Registration Certificates <ul> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_06_08.pdf" target="_blank" rel="noopener noreferrer">2006-2008<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_09.pdf" target="_blank" rel="noopener noreferrer">2009<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_10.pdf" target="_blank" rel="noopener noreferrer">2010<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_11.pdf" target="_blank" rel="noopener noreferrer">2011<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_12.pdf" target="_blank" rel="noopener noreferrer">2012<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_13.pdf" target="_blank" rel="noopener noreferrer">2013<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_2014.pdf" target="_blank" rel="noopener noreferrer">2014<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_2015.pdf" target="_blank" rel="noopener noreferrer">2015<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/med_div_-2016.pdf" target="_blank" rel="noopener noreferrer">2016<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> </ul> </li> </ol> </div></div> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000" href="#collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-4"> Organogram<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-4" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="margin-bottom-20"> <div class=""> <span > <img src="/opencms/export/sites/CDSCO_WEB/Image_folder/Organogrammd24.jpg" class=" img-responsive " alt="Medical Device Organogram" title="Medical Device Organogram " /> </span> </div> </div> </div></div> </div> </div> <div class="panel panel-default bg-white"> <div class="panel-heading"> <h4 class="panel-title"> <a class="text-dark " data-bs-toggle="collapse" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000" href="#collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-5"> Guideline<i class="more-less glyphicon glyphicon-plus-sign"></i> </a> </h4> </div> <div id="collapse731bc9a1-2e67-11e8-9c7f-0a0027000000-5" class="panel-collapse collapse " style="height: 0px;" data-bs-parent="#bs-collapse731bc9a1-2e67-11e8-9c7f-0a0027000000""> <div class="panel-body"> <div class="panel-body" ><div class="none"> <div > <div ><div class="panel-body"> <ul> <li style="text-align: justify;"><a style="color: black; text-decoration: none;" title="Guidelines Document" href="#"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/faculty30x30.png" alt="image" /> <strong>Guidelines Document</strong></a><strong><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Guidance1.pdf" target="_blank" rel="noopener noreferrer"><em class="fa fa-file-pdf-o" aria-hidden="true"> </em> </a></strong> <ol> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Guidance-document-for-Registration-of-Non-Notified-Medical-Devices..pdf" target="_blank" rel="noopener noreferrer">Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices<em class="fa fa-file-pdf-o" aria-hidden="true">  </em></a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/fscguidancerev2024.pdf" target="_blank" rel="noopener">Guidance Document for obtaining Free sale certificate for licensed Medical Devices in India<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/guidanceperformanceivd.pdf" target="_blank" rel="noopener noreferrer">Guidance on Performance Evaluation on In Vitro Diagnostic Medical Devices  </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Guidelines_Grouping_of_MDandIVD.pdf" target="_blank" rel="noopener noreferrer">Guidance Document on Grouping of Medical Devices and IVD </a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/MD-MSC-NCCguidannce.pdf">Guidance document for obtaining Market Standing Certificate & Non conviction certificate for licensed Medical Devices in India</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/RegulatoryMDR-2017.pdf" target="_blank" rel="noopener">Regulatory Pathway to be followed for Medical Devices under MDR-2017</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/FormMD7n.pdf" target="_blank" rel="noopener">Form MD-7 Specimen proforma for Medical Devices</a></li> <li style="text-align: justify;"><a href="https://cdsco.gov.in/opencms/opencms/Pdf-documents/medical-device/Form MD8n.pdf" target="_blank" rel="noopener">Form MD-8 Specimen proforma for Medical Devices</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/FormMD14n.pdf" target="_blank" rel="noopener">Form MD-14 Specimen proforma for Medical Devices</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/FormMD12.pdf" target="_blank" rel="noopener">Form MD-12 Specimen proforma for Medical Devices</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/FormMD16.pdf" target="_blank" rel="noopener">Form MD-16 Specimen proforma for Medical Devices</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/FormMD22.pdf" target="_blank" rel="noopener">Form MD-22 Specimen proforma for Medical Devices</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/FormMD26.pdf" target="_blank" rel="noopener">Form MD-26 Specimen proforma for Medical Devices</a></li> </ol> </li> <li style="text-align: justify;"><a style="color: black; text-decoration: none;" title="Sugam User Manual" href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/SUGAM_user_manual.pdf" target="_blank" rel="noopener noreferrer"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/UserguidePNG30x30.png" alt="UserguidePNG(30x30)" /> <strong>Sugam User Manual</strong></a></li> <li style="text-align: justify;"><a style="color: black; text-decoration: none;" title="FAQ" href="#"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/faq_icon30x30.png" alt="faq_icon(30x30)" /><strong> FAQ</strong></a> <ol> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/MDfAq24.pdf" target="_blank" rel="noopener">FAQ on Medical Device Rule,2017<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/FAQ_GroupingGuidelines.pdf" target="_blank" rel="noopener noreferrer">FAQ on Grouping Guidelines<em class="fa fa-file-pdf-o" aria-hidden="true">  </em> </a></li> </ol> </li> <li><a style="color: black; text-decoration: none;" title="Chechlist Document" href="#"><img src="/opencms/export/system/modules/CDSCO.WEB/resources/img/icons/iStock30x30.jpg" alt="iStock(30x30)" />  <strong>Checklist Documents</strong></a> <ol> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Checklist-for-NCC-MD.pdf" target="_blank" rel="noopener">Checklist for Grant of Non Conviction Certificate for Medical Devices</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Checklist-for-MSC-MD.pdf" target="_blank" rel="noopener">Checklist for Grant of Market Standing Certificate for Medical Devices</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Checklist-for-FSC-MD.pdf" target="_blank" rel="noopener">Checklist for Grant of Free Sale Certificate for Medical Devices</a></li> <li style="text-align: justify;"><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/7MD.pdf" target="_blank" rel="noopener">Checklist for Form MD-7 MD</a></li> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/8MD.pdf" target="_blank" rel="noopener">Checklist for Form MD-8 MD</a></li> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/12MD.pdf" target="_blank" rel="noopener">Checklist for Form MD-12 MD</a></li> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/14MD.pdf" target="_blank" rel="noopener">Checklist for Form MD-14 MD</a></li> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/16MD.pdf" target="_blank" rel="noopener">Checklist for Form MD-16 MD</a></li> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/ChecklisFormMD-22MD.pdf" target="_blank" rel="noopener">Checklist for Form MD-22MD</a></li> <li><a href="/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/26MD.pdf" target="_blank" rel="noopener">Checklist for Form MD-26 MD</a></li> </ol> </li> </ul> </div></div> </div> </div> </div></div> </div> </div> </div> </div> </div></div> </div> </div>   <div class="row section3 "> <div class="col-md-12 section3_medical">    <div class="col-md-12 col-sm-12 col-xs-12 pad-top double" id="med_nav"> <!DOCTYPE html> <html lang="en"> <head> <style> ul { list-style-type: none; } li{ list-style-type: none; padding-top:3px; } </style> <script> $(document).ready(function() { $(".btn-pref .btn").click(function () { $(".btn-pref .btn").removeClass("btn-primary").addClass("btn-default"); // $(".tab").addClass("active"); // instead of this do the below $(this).removeClass("btn-default").addClass("btn-primary"); }); }); </script> <div class="col-lg-12 col-sm-12"> <ul class="btn-pref nav nav-tabs" id="myTab" role="tablist"> <li class="nav-item" role="presentation"> <button type="button" id="alerts" class="w-100 active btn btn-primary" data-bs-target="#tab1" data-bs-toggle="tab" aria-selected="true" aria-controls="#tab1"><i class="fa fa-exclamation-triangle"></i> <div class="hidden-xs">Alerts</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="news" class="w-100 btn btn-default" data-bs-target="#tab2" data-bs-toggle="tab"><i class="fa fa-newspaper-o"></i> <div class="hidden-xs">News</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="notices" class="w-100 btn btn-default" data-bs-target="#tab3" data-bs-toggle="tab"><i class="fa fa-file-text"></i> <div class="hidden-xs">Public Notices</div> </button> </li> <li class="nav-item" role="presentation"> <button type="button" id="gazette" class="w-100 btn btn-default" data-bs-target="#tab4" data-bs-toggle="tab"><i class="fa fa-bell"></i> <div class="hidden-xs">Gazette Notifications</div> </button> </li> </ul> <div class="tab-content"> <div class="tab-pane fade show active" id="tab1"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>Medical Device Alert dated 08 May 2023</td> <td>2023-May-23</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTAxODI='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1842 KB</td> </tr> <tr> <td>2</td> <td>Medical Device Alert dated 29 Dec 2022</td> <td>2023-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTc1Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>916 KB</td> </tr> <tr> <td>3</td> <td>Medical Device Alert date 21 July 2022</td> <td>2022-Jul-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODgyNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1328 KB</td> </tr> <tr> <td>4</td> <td>Medical Device Alert date 21 June 2022</td> <td>2022-Jun-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODY1OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>5121 KB</td> </tr> <tr> <td>5</td> <td>Medical Device Alert date 14 June 2022</td> <td>2022-Jun-14</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODYxNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>955 KB</td> </tr> <tr> <td>6</td> <td>Medical Devices Alert 8 November 2021</td> <td>2021-Nov-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=Nzg4MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2370 KB</td> </tr> <tr> <td>7</td> <td>Medical Devices Alert on MiniMed 620G Insulin Pump/Pump Kits & MiniMed 640G Insulin Pump/Pump kit of India Medtronic Ltd</td> <td>2021-Oct-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=Nzc3MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1976 KB</td> </tr> <tr> <td>8</td> <td>Alert_FSN-Medtronic Heartware HVAD</td> <td>2021-Sep-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzY4NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>285 KB</td> </tr> <tr> <td>9</td> <td>Medical Devices alert for Ventilator of Philips August 2021</td> <td>2021-Aug-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU3MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>659 KB</td> </tr> <tr> <td>10</td> <td>Medical Devices alert july 2019</td> <td>2019-Jul-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDU0MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>567 kb</td> </tr> <tr> <td>11</td> <td>Medical Device Alert Dated 20.05.2019</td> <td>2019-May-20</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDQ3MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>88 KB</td> </tr> <tr> <td>12</td> <td>NOC update list of Medical Devices 2013</td> <td>2018-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAzNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>95 KB</td> </tr> <tr> <td>13</td> <td>NOC update list of Medical Devices 2018</td> <td>2018-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA0Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>225 KB</td> </tr> <tr> <td>14</td> <td>NOC update list of Medical Devices 2017</td> <td>2018-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA0MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>914 KB</td> </tr> <tr> <td>15</td> <td>NOC update list of Medical Devices 2016</td> <td>2018-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA0MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>138 KB</td> </tr> <tr> <td>16</td> <td>NOC update list of Medical Devices 2015</td> <td>2018-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAzOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>162 KB</td> </tr> <tr> <td>17</td> <td>NOC of Medical Devices 2011</td> <td>2018-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAzNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>91 KB</td> </tr> <tr> <td>18</td> <td>NOC Updated list of Medical Devices 2012</td> <td>2018-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAzNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>112 KB</td> </tr> <tr> <td>19</td> <td>NOC update list of Medical Devices 2014</td> <td>2018-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAzOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>79 KB</td> </tr> <tr> <td>20</td> <td>List of Clarifications/NOCs Issue from 2011- 2018</td> <td>2018-Aug-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTg3Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1280 KB</td> </tr> <tr> <td>21</td> <td>List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of MAY, 2018</td> <td>2018-Jun-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTcxNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>390KB</td> </tr> <tr> <td>22</td> <td>Drug Alert for the month of April,2018</td> <td>2018-Jun-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTY2Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>80KB</td> </tr> <tr> <td>23</td> <td> Destroy of the product demaged due to fire</td> <td>2017-Jul-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI2NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>57 KB</td> </tr> <tr> <td>24</td> <td>MEDICAL DEVICE ALERT FOR " Absorb Bioresorbale Vascular Scaffold BVS and Absorb GT1 Bioresorbale Vascular Scaffold BVS </td> <td>2017-Jun-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI2Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1274 KB</td> </tr> <tr> <td>25</td> <td>Medical Devices alert 02.06.2017</td> <td>2017-Jun-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE0Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1125 KB</td> </tr> <tr> <td>26</td> <td>MEDICAL DEVICE ALERT FOR " Beacon Tip Torcon NB Advantage Catheter</td> <td>2017-Jun-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI2Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1125 KB</td> </tr> <tr> <td>27</td> <td>Medical Devices alert 13.04.2017</td> <td>2017-Apr-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE0NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1048 KB</td> </tr> <tr> <td>28</td> <td>Medical Devices alert 07.04.2017</td> <td>2017-Apr-07</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE0NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1134 KB</td> </tr> <tr> <td>29</td> <td>Non-conviction Certificate</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI5Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>6 kb</td> </tr> <tr> <td>30</td> <td>Medical Devices alert 21.10.2016</td> <td>2016-Oct-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE0Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>868 KB</td> </tr> <tr> <td>31</td> <td>Confidence Spinal Cement System</td> <td>2014-Jan-15</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk2'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>241kb</td> </tr> <tr> <td>32</td> <td>MEDICAL DEVICE ALERT FOR PRODUCT "HT Connect Peripheral Guidewire</td> <td>2014-Jan-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI2Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>241 KB</td> </tr> <tr> <td>33</td> <td>LPS Lower Extremity Dovetail IntercalaryComponent</td> <td>2013-Dec-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTkz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>238kb</td> </tr> <tr> <td>34</td> <td>Cancellous Bone Screws (A Component of the Hip System)</td> <td>2013-Dec-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk0'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>209kb</td> </tr> <tr> <td>35</td> <td>HT Connect Peripheral Guidewire</td> <td>2013-Dec-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>241kb</td> </tr> <tr> <td>36</td> <td>ECHELON Endoscopic Liner Cutter Reloads Black(ECR60T)</td> <td>2013-Dec-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>268kb</td> </tr> <tr> <td>37</td> <td>ONYX Liquid Embolic System</td> <td>2013-Dec-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTky'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>266kb</td> </tr> <tr> <td>38</td> <td>ASR XL Acetabular System & DePuy ASR Hip Resurfacing System</td> <td>2013-Dec-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk1'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>266kb</td> </tr> </tbody> </table> </div> </div> </div> <div class="tab-pane fade " id="tab2"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example1" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example1"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>Seminar on Strengthening Medical Device Licence Holders on Post-Market Safety Surveillance Practices in India and Medical Device Stakeholders Consultation Meeting PGIMER Chandigarh on 3rd September 2024</td> <td>2024-Jul-26</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTE0Nzk='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1515 KB</td> </tr> <tr> <td>2</td> <td>Applicant User Manual For Form MD-41</td> <td>2022-Nov-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTIxNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1335 KB</td> </tr> <tr> <td>3</td> <td>FSCA Form</td> <td>2019-Apr-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDMwNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>404KB</td> </tr> <tr> <td>4</td> <td> Medical Device Adverse Event Reporting Form</td> <td>2019-Apr-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDMwNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>460 KB</td> </tr> <tr> <td>5</td> <td>Frequently Asked Questions on Medical Device Rule 2017</td> <td>2018-Dec-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjY4MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>244 KB</td> </tr> <tr> <td>6</td> <td>Guidance Documents on Free Sale Certificate of Notified Medical Devices in India</td> <td>2018-Nov-06</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA3OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>446KB</td> </tr> <tr> <td>7</td> <td>Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices</td> <td>2018-Aug-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTkwNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>144 KB</td> </tr> <tr> <td>8</td> <td>Grant of additional products & certificates like i.e. Market standing certificate, Non-conviction certificate and performance certificate etc. w.r.t. Medical Devices and In-vitro Diagnostics</td> <td>2018-Aug-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTg5NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>408 KB</td> </tr> <tr> <td>9</td> <td>The National Coordination Centre (NCC)-Materiovigilance Programme of India (MvPI) has released Draft Guidance Document for Medical Devices. This is a unique document which covers all the relevant information related to Medical Device under one umbrella. Guidance Document is now available to seek stakeholderâs comments till 01/09/2018 (30 calendar days)</td> <td>2018-Aug-06</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTg5Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>9,461,760 KB</td> </tr> <tr> <td>10</td> <td>Quality Control testing of viral load monitoring kits for HIV, HCV and HBV-Reg</td> <td>2018-Jul-24</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTgzOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>639 KB</td> </tr> <tr> <td>11</td> <td>Workshop for MD & IVD manufacturers on 19.02.2018</td> <td>2018-Feb-19</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>110 KB</td> </tr> <tr> <td>12</td> <td>FAQ_IVD_MDR-2018</td> <td>2018-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1037 KB</td> </tr> <tr> <td>13</td> <td>List of Clarifications/NOCs Issue from 2011- 2018</td> <td>2018-Jan-16</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMyNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2800 KB</td> </tr> <tr> <td>14</td> <td>TR6 Challan</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwMA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>120 KB</td> </tr> <tr> <td>15</td> <td>Additional Clarification with Regard to Control of Various Medical Devices (20.03.2008)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>147 KB</td> </tr> <tr> <td>16</td> <td>ALLERGEN PRODUCTS CHECKLIST FOR VERIFICATION OF INFORMATION TO BE PROVIDED BY APPLICATION AT CDSCO</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI5Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>89 KB</td> </tr> <tr> <td>17</td> <td>Form 40</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwMg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>112 KB</td> </tr> <tr> <td>18</td> <td>Form 8</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>108 KB</td> </tr> <tr> <td>19</td> <td>Report of the committee to examine the issues relating to the essentiality of coronary stents</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>8281 KB</td> </tr> <tr> <td>20</td> <td>Regulation of Medical Device covered Under Notified Medical Device</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>74 KB</td> </tr> <tr> <td>21</td> <td>Grouping Guidelines for Medical Device Applications</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzMg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1984 KB</td> </tr> <tr> <td>22</td> <td>Guidance document on application for grant of licence in Form-28 for manufacture of Medical Devices in India Under CLAA Scheme</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>701 KB</td> </tr> <tr> <td>23</td> <td>Guidance document on common submission format for Manufacture of Medical Devices (Form-28) Under CLAA Scheme</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>238 KB</td> </tr> <tr> <td>24</td> <td>Guidance document on common Submission Format for Registration(Form-41)(Excluding Notified IVD's), Import Licence(Form 10)(Excluding IVD's) and Manufacture of Medical Devices (Form- 28) Under CLAA Scheme</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>283 KB</td> </tr> <tr> <td>25</td> <td>Proposal invited for designation of Central Medical Device testing lab for Medical devices including In-Vitro Diagnostic medical Device under Medical Devices Rules, 2017</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzMw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>638 KB</td> </tr> <tr> <td>26</td> <td>Guidelines for Import and Manufacture of Medical Devices (01.03.2006</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>170 KB</td> </tr> <tr> <td>27</td> <td>Guidelines on Essential Principles for safety and performance of Medical Devices</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzMQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>8264 KB</td> </tr> <tr> <td>28</td> <td>Power of Attorney</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwMQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>122 KB</td> </tr> <tr> <td>29</td> <td>Performance Certificate</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI5OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>332 KB</td> </tr> <tr> <td>30</td> <td>Orthopedics MDAC</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMyMw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>193 KB</td> </tr> <tr> <td>31</td> <td>MEDICAL DEVICE (TEST LICENSE)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI5NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>169 KB</td> </tr> <tr> <td>32</td> <td>MEDICAL DEVICE REGISTRATION CERTIFICATE</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI5NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>133 KB</td> </tr> <tr> <td>33</td> <td>MEDICAL DEVICE (CLINICAL TRIAL)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI5Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>115 KB</td> </tr> <tr> <td>34</td> <td>CHECKLIST/PERFORMA TO BE PROVIDED FOR VERIFICATION OF INFORMATION ON ALLERGEN IVD BY APPLICANT FOR GRANT OF FORM 10</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>89 KB</td> </tr> <tr> <td>35</td> <td>Import Registration Certificates for Medical Devices issued 2017</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>138 KB</td> </tr> <tr> <td>36</td> <td>List of Clarifications/NOCs Issue from 2011- Oct 2017</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>901 KB</td> </tr> <tr> <td>37</td> <td>Medical Device Adverse Event reporting form</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1655 KB</td> </tr> <tr> <td>38</td> <td>Market Standing Certificate</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI5OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>6 KB</td> </tr> <tr> <td>39</td> <td>List of Notified Medical Devices </td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMyNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>85 KB</td> </tr> <tr> <td>40</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2017</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM3Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1557 KB</td> </tr> <tr> <td>41</td> <td>Clarification For Import of Freezing Bags Transfer Set</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>128 KB</td> </tr> <tr> <td>42</td> <td>Clarification for Import of Non-Notified Medical Devices</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>212 KB</td> </tr> <tr> <td>43</td> <td>Clarification for Import of Pre filled Syringes Components</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>282 KB</td> </tr> <tr> <td>44</td> <td>Clarification for Import of Raw Materials in bulk form in Rolls/Bundle for Manufacture of Finished Product (Sutures)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>258 KB</td> </tr> <tr> <td>45</td> <td>Clarification on Guidelines for Import & Manufacture of Medical Device</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>195 KB</td> </tr> <tr> <td>46</td> <td>Clarification on Regulation of Stapler (Staples)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM2MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>54 KB</td> </tr> <tr> <td>47</td> <td>Classification of Medical devices and in Vitro diagnostic Medical devices under the provisions of the Medical Devices Rules 2017</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>4147 KB</td> </tr> <tr> <td>48</td> <td>Non- Compliance observed During Review Process of application for Registration & Import Licenses of Medical Devices</td> <td>2016-Feb-23</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI4MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>198 KB</td> </tr> <tr> <td>49</td> <td>Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagent</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>55 KB</td> </tr> <tr> <td>50</td> <td>Form 12A</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>97 KB</td> </tr> <tr> <td>51</td> <td>Form 12AA</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>108 KB</td> </tr> <tr> <td>52</td> <td>Form 27</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>171 KB</td> </tr> <tr> <td>53</td> <td>Guidance Document on Common Submission Format for Import License in Form-10 of Notified Medical Devices in India (01.01.2013)</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI4Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>467 KB</td> </tr> <tr> <td>54</td> <td>Import Registration Certificates for Medical Devices issued 2016</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>872 KB</td> </tr> <tr> <td>55</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2016</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM3NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>996 KB</td> </tr> <tr> <td>56</td> <td>MDAC - CARDIOVASCULAR</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxMA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>121 KB</td> </tr> <tr> <td>57</td> <td>MDAC - DENTAL</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxMQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>52 KB</td> </tr> <tr> <td>58</td> <td>MDAC - ORTHOPAEDIC</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxMg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>321 KB</td> </tr> <tr> <td>59</td> <td>MDAC - REPRODUCTIVE & UROLOGY </td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxMw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>47 KB</td> </tr> <tr> <td>60</td> <td>Medical Device Licensed Manufacturing units in Various State of India</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>403 KB</td> </tr> <tr> <td>61</td> <td>Miscellaneous MDAC</td> <td>2016-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMyNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>69 KB</td> </tr> <tr> <td>62</td> <td>Minutes of the Meeting held on 05.12.2015</td> <td>2015-Dec-05</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>264 KB</td> </tr> <tr> <td>63</td> <td>Revised Schedule MIII For Finalized by sub committee of DTAB </td> <td>2015-Aug-19</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI2OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>525 KB</td> </tr> <tr> <td>64</td> <td>Revised Pre-Screening checklist for acceptability of application of Medical Device and Invitro Diagnostic w.e.f 01.07.2015 </td> <td>2015-Jul-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI2Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>559 KB</td> </tr> <tr> <td>65</td> <td>REQUIREMENTS FOR CONDUCTING CLINICAL TRIALS OF MEDICAL DEVICES IN INDIA</td> <td>2015-Feb-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI4Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2671 KB</td> </tr> <tr> <td>66</td> <td>Form 9</td> <td>2015-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>109 KB</td> </tr> <tr> <td>67</td> <td>Import Registration Certificates for Medical Devices issued 2015</td> <td>2015-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1322 KB</td> </tr> <tr> <td>68</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2015</td> <td>2015-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM3NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>879 KB</td> </tr> <tr> <td>69</td> <td>Frequently asked Question on registration and import of medical devices in India </td> <td>2015-Feb-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI3Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>808 KB</td> </tr> <tr> <td>70</td> <td>Form 12</td> <td>2014-Jun-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>104 KB</td> </tr> <tr> <td>71</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2014</td> <td>2014-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM3Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>468 KB</td> </tr> <tr> <td>72</td> <td>Import Registration Certificates for Medical Devices issued 2014</td> <td>2014-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1214 KB</td> </tr> <tr> <td>73</td> <td>Dental MDAC</td> <td>2014-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMyMQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>341 KB</td> </tr> <tr> <td>74</td> <td>Guidance Document on Application for Grant of License in Form-28 for Manufacture of Medical Devices in India Under CLAA Scheme(01.01.2013)</td> <td>2014-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI4OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>809 KB</td> </tr> <tr> <td>75</td> <td>Form 44</td> <td>2014-Feb-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMwMw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>109 KB</td> </tr> <tr> <td>76</td> <td>Guidance Document on Common Submission Format for Registration/ Re-Registration of Notified Medical Devices in India (01.01.2013)</td> <td>2013-Dec-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI4OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>777 KB</td> </tr> <tr> <td>77</td> <td>Cardiovascular MDAC</td> <td>2013-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMyMg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>615 KB</td> </tr> <tr> <td>78</td> <td>Import Registration Certificates for Medical Devices issued 2013</td> <td>2013-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>940 KB</td> </tr> <tr> <td>79</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2013</td> <td>2013-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM3Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>284 KB</td> </tr> <tr> <td>80</td> <td>Import Registration Certificates for Medical Devices issued 2012</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>685 KB</td> </tr> <tr> <td>81</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2012</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM3OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>199 KB</td> </tr> <tr> <td>82</td> <td>Import Registration Certificates for Medical Devices issued 2011</td> <td>2011-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>580 KB</td> </tr> <tr> <td>83</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2011</td> <td>2011-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM3OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>139 KB</td> </tr> <tr> <td>84</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2010</td> <td>2010-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>184 KB</td> </tr> <tr> <td>85</td> <td>Import Registration Certificates for Medical Devices issued 2010</td> <td>2010-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>871 KB</td> </tr> <tr> <td>86</td> <td>Import Registration Certificates for Medical Devices issued 2009</td> <td>2009-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>441 KB</td> </tr> <tr> <td>87</td> <td>List of Licensed indigenous Manufacturers of Medical Devices Year 2009</td> <td>2009-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM4MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>221 KB</td> </tr> <tr> <td>88</td> <td>Import Registration Certificates for Medical Devices issued 2006-2008</td> <td>2008-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM1Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>807 KB</td> </tr> </tbody> </table> </div> </div> </div> <div class="tab-pane fade" id="tab3"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example2" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example2"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>Updation of exisiting risk based classification list_draft_dated 06 01 2025 for stakeholder comments</td> <td>2025-Jan-06</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>3025 KB</td> </tr> <tr> <td>2</td> <td>Merged existing Medical Devices risk-classification</td> <td>2025-Jan-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzMjU='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>18,028 KB</td> </tr> <tr> <td>3</td> <td>MEDICAL DEVICE ADVERSE EVENT REPORTING FORM Version 1.2</td> <td>2024-Oct-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIwNDU='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>656 KB</td> </tr> <tr> <td>4</td> <td>Circular- Testing and evaluaion of Medical Devices/ In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country</td> <td>2024-May-29</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEzMTg='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>429 KB</td> </tr> <tr> <td>5</td> <td>Notice to All stakeholders for Strengthening of Private Medical Device Testing Laboratory</td> <td>2024-Apr-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwNzI='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>388 KB</td> </tr> <tr> <td>6</td> <td>Online application for Neutral Code for manufacturing of Medical Devices for export purpose</td> <td>2024-Feb-12</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA5Mjk='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>305 KB</td> </tr> <tr> <td>7</td> <td>Launching of National Single Window System (NSWS) Portal</td> <td>2024-Jan-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA4MTE='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>3669 KB</td> </tr> <tr> <td>8</td> <td>Regulation of all Class C & D Medical Devices Under Licensing regime, w.e,f 01.10.2023 as per GSR102E dated 11.02.2020</td> <td>2023-Oct-12</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1NzM='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>385 KB</td> </tr> <tr> <td>9</td> <td>Clarification on the Circular no. 29/Misc/03/2023-DC(344) datedÂ 12.10.2023</td> <td>2023-Oct-12</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1NzU='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>22 KB</td> </tr> <tr> <td>10</td> <td>List of medical devices testing laboratory (MDTL) for carry out test or evaluation of medical device on behalf of manufacturer registered with CDSCO under MDR 2017</td> <td>2023-Sep-15</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTA1MTE='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1635 KB</td> </tr> <tr> <td>11</td> <td>Circular for Licensing of Class C D medical devices dated 12.04.2023</td> <td>2023-Apr-12</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTAwMjM='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>310 KB</td> </tr> <tr> <td>12</td> <td>List of Notified Bodies registered with CDSCO under MDR, 2017</td> <td>2023-Apr-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTAwMDg='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>830 KB</td> </tr> <tr> <td>13</td> <td>Registration of Medical Device Testing Laboratory in Form MD-40 as per Medical Devices Rules (MDR) 2017 for Testing of Medical Devices on behalf of the manufacturer</td> <td>2022-Dec-22</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTY4NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>412 KB</td> </tr> <tr> <td>14</td> <td>Classification of Medical Device pertaining to Oncology under the provisions of Medical Devices Rules, 2017</td> <td>2022-Oct-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTExOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>817 KB</td> </tr> <tr> <td>15</td> <td>Classification of Medical Device Pertaining to Dental Under the provision of Medical Devices Rules 2017</td> <td>2022-Oct-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTExOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>764 KB</td> </tr> <tr> <td>16</td> <td>Regulation of all Class A & B Medical Devices under Licensing regime, w.e.f 01.10.2022, as per G.S.R. 102(E) dt 11.02.2020</td> <td>2022-Sep-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA1Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>401 KB</td> </tr> <tr> <td>17</td> <td>Notice regarding implementation of gazette notification vide GSR 754(E) dated 30.09.2022</td> <td>2022-Sep-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTEzNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>290 KB</td> </tr> <tr> <td>18</td> <td>Strengthening of Medical Products Safety Surveillance System in North Eastern States of India on October 19 2022 at Government Pharmacy College Sajong Sikkim</td> <td>2022-Sep-29</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA1Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1476 KB</td> </tr> <tr> <td>19</td> <td>Classification of Medical Device Pertaining to non-sterile, non-powered, hand-held or hand-manipulated Surgical Instruments for general use intended to be used in various general surgical procedures</td> <td>2022-Sep-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTAwOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>524 KB</td> </tr> <tr> <td>20</td> <td>List of the Certified Medical Device Testing Laboratory under MDR, 2017</td> <td>2022-Aug-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg4Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>5938 KB</td> </tr> <tr> <td>21</td> <td>Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devcies Rules 2017</td> <td>2022-Aug-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg1OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>852 KB</td> </tr> <tr> <td>22</td> <td>Notice dated July 11 2022</td> <td>2022-Jul-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODc3MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>370 KB</td> </tr> <tr> <td>23</td> <td>Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017</td> <td>2022-Jun-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODU0OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>529 KB</td> </tr> <tr> <td>24</td> <td>Classification of Medical Device pertaining to General Hospital under the provisions of Medical Devices Rules 2017</td> <td>2022-Mar-16</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODI1Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>813 KB</td> </tr> <tr> <td>25</td> <td>Regulation of CT scan equipment_All Implantable Devices_MRI equipment etc. as Drugs with effect from April 1st 2021</td> <td>2021-Nov-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=Nzg0Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>246 KB</td> </tr> <tr> <td>26</td> <td>Classification of Medical Device pertaining to Neurological under the provisions of Medical Devices Rules, 2017</td> <td>2021-Sep-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzcyNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>367 KB</td> </tr> <tr> <td>27</td> <td>Registration and Labelling requirements of Medical Devices</td> <td>2021-Sep-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzczMA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>366 KB</td> </tr> <tr> <td>28</td> <td>Classification of Medical Device pertaining to Gastroenterology under the provisions of Medical Devices Rules, 2017</td> <td>2021-Sep-27</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzcyNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>929 KB</td> </tr> <tr> <td>29</td> <td>Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices</td> <td>2021-Sep-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzcwMQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>513 KB</td> </tr> <tr> <td>30</td> <td>Classification of Medical Device pertaining to Nephrology and Renal Care under the provisions of Medical Devices Rules 2017</td> <td>2021-Sep-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzY2Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>744 KB</td> </tr> <tr> <td>31</td> <td>Classification of Medical Device pertaining to Operation Theatre under the provisions of Medical Devices Rules 2017</td> <td>2021-Sep-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzY2Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>804 KB</td> </tr> <tr> <td>32</td> <td>Classification of Medical Device pertaining to Pain Management under the provisions of Medical Devices Rules 2017</td> <td>2021-Sep-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzcyOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>334 KB</td> </tr> <tr> <td>33</td> <td>Classification of Medical Device pertaining to Personal Protective Equipment under the provisions of Medical Devices Rules 2017</td> <td>2021-Sep-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzY2MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>674 KB</td> </tr> <tr> <td>34</td> <td>Classification of Medical Device pertaining to Software under the provisions of Medical Devices Rules 2017</td> <td>2021-Sep-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzY1OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>698 KB</td> </tr> <tr> <td>35</td> <td> The list of standards published under Medical Equipment and Hospital Planning (MHD) of BIS as forwarded by BIS for ready reference</td> <td>2021-Sep-07</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzYzNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>665 KB</td> </tr> <tr> <td>36</td> <td>List of Medical devices testing Laboratory for carry out test or evaluation of Medical device on behalf of Manufacturer registered with CDSCO under MDR</td> <td>2021-Aug-27</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzYyMQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>3982 KB</td> </tr> <tr> <td>37</td> <td>Classification of Medical Device Pertaining to Urology Under the provision of Medical Devices Rules 2017</td> <td>2021-Aug-23</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU5Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>955 KB</td> </tr> <tr> <td>38</td> <td>Classification of Medical Device Pertaining to Pediatrics and Neonatology Under the provision of Medical Devices Rules 2017</td> <td>2021-Aug-23</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU5Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1120 KB</td> </tr> <tr> <td>39</td> <td>Classification of Medical Devices Pertaining to Ophthalmology under the Provisions of Medical Devices Rules 2017</td> <td>2021-Aug-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU3MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>889 KB</td> </tr> <tr> <td>40</td> <td>Classification of Medical Device Pertaining to Radiotherapy under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021</td> <td>2021-Aug-06</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU2Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>606 KB</td> </tr> <tr> <td>41</td> <td>Classification of Medical Device Pertaining to Respiratory Under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021</td> <td>2021-Aug-06</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU2NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>628 KB</td> </tr> <tr> <td>42</td> <td>Classification of Medical Devices Pertaining to ENT under the Provisions of Medical Devcies Rules 2017 dated 6 August 2021</td> <td>2021-Aug-06</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU2Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>601 KB</td> </tr> <tr> <td>43</td> <td>Classification of medical device pertaining to Cardiovascular under the provisions of Medical Devices Rules 2017</td> <td>2021-Jul-26</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ5Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>523 KB</td> </tr> <tr> <td>44</td> <td>Classification of Medical Device Pertaining to Physical Support under the Provisions of Medical Devcies Rules 2017</td> <td>2021-Jul-26</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>618 KB</td> </tr> <tr> <td>45</td> <td>Classification of Medical Device Pertaining to Interventional Radiology under the Provisions of Medical Devcies Rules 2017</td> <td>2021-Jul-26</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>432 KB</td> </tr> <tr> <td>46</td> <td>Classification of Medical Device Pertaining to Dermatological and Plastic Surgery under the Provisions of Medical Devcies Rules 2017</td> <td>2021-Jul-26</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQ1Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>256 kB</td> </tr> <tr> <td>47</td> <td>Classification of medical devices pertaining of Anesthesiology under the provision of Medical Devices Rules 2017</td> <td>2021-Jul-12</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzcyOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>200 KB</td> </tr> <tr> <td>48</td> <td>List of medical devices testing laboratory for carry out test or evaluation of medical device on behalf of manufacturer with CDSCO under MDR 2017</td> <td>2021-Jul-07</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzQwOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>4025 KB</td> </tr> <tr> <td>49</td> <td>Regulation of CT Scan equipment, All Implantable Devices, MRI equipment etc. as Drugs with effect from April 1st 2021</td> <td>2021-Apr-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzE0Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>138 KB</td> </tr> <tr> <td>50</td> <td>Regulation of Blood Glucose monitors Blood pressure monitors Nebulizers and Thermometers as drugs with effect from Jan 1st 2021</td> <td>2020-Dec-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=Njc5Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>334 KB</td> </tr> <tr> <td>51</td> <td>Notice regarding List of medical devices testing Laboratory</td> <td>2020-Oct-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjU1Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2927 KB</td> </tr> <tr> <td>52</td> <td>Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices</td> <td>2020-Sep-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQ0OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>301 KB</td> </tr> <tr> <td>53</td> <td>Submission of notarized/apostilled documents for import of medical device and in-vitro diagnostic kits in view of Covid-19</td> <td>2020-Aug-31</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQyOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>343 KB</td> </tr> <tr> <td>54</td> <td>Requirement of fees for change in address of authorized agent without change in constitution as post approval Change under MDR 2017</td> <td>2020-Aug-31</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjQzMA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>362 KB</td> </tr> <tr> <td>55</td> <td> Clarification regarding import of diagnostic kits/ reagents for Research use only ROU for academic research purpose</td> <td>2020-Jun-19</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjAwNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>368 KB</td> </tr> <tr> <td>56</td> <td>Submission of notarized/apostilled document for import and registration of medical devices in view of covid-19</td> <td>2020-Apr-23</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTg4NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>307 KB</td> </tr> <tr> <td>57</td> <td>Strengthening of Materiovigilance Programme of India (MvPI) in the country</td> <td>2019-Nov-26</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTMxMw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>56 KB</td> </tr> <tr> <td>58</td> <td>Processing of application for product approved as medical device in the country of origin, but covered under the definition of drug in the country-reg</td> <td>2019-Nov-15</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTI0Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>289 KB</td> </tr> <tr> <td>59</td> <td>Notice regarding equipments which are non notified but associated with notified devices</td> <td>2019-Nov-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTIyOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>226 KB</td> </tr> <tr> <td>60</td> <td>Notice regarding environmental conditions for equipments</td> <td>2019-Nov-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTIyOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>235 KB</td> </tr> <tr> <td>61</td> <td>Notice regarding exemption of drugs Sale License</td> <td>2019-Nov-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTIyMg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>235 KB</td> </tr> <tr> <td>62</td> <td>Notice regarding all implantable devices</td> <td>2019-Nov-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTIyMA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>252 KB</td> </tr> <tr> <td>63</td> <td>Notice regarding Notification to notify all the medical device under sub-section (b) of Section 3 of th Drugs and Cosmetics Act 1940 to regulate them as per the provisions of the Act and Medical Devices Rules 2017</td> <td>2019-Oct-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTE3OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1962 KB</td> </tr> <tr> <td>64</td> <td>Constitution of Medical Devices Technical advisory group (MDTAG) to advise CDSCO on matter related to regulation of medical devices-Reg</td> <td>2019-Jul-22</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDcwNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>650 KB</td> </tr> <tr> <td>65</td> <td>Classification of Newly Notified Medical Devices to be updated with Classification list of Medical Devices and IVDs</td> <td>2019-May-15</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDM5Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2021 KB</td> </tr> <tr> <td>66</td> <td>Formula for grant of Compensation to the patients who were implanted with ASR Hip and Constitution of the state Level Committee</td> <td>2018-Nov-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzEzNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>2586 KB</td> </tr> <tr> <td>67</td> <td>Health Ministry approves compensation formula for Hip implant cases</td> <td>2018-Nov-29</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzEwMw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>157 KB</td> </tr> <tr> <td>68</td> <td>Application form for Compensation-DePuy_Johnson</td> <td>2018-Nov-15</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzEwMQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>118 KB</td> </tr> <tr> <td>69</td> <td>To provide guidance and advertisement for compensation to patients implanted with ASR Hip Implants</td> <td>2018-Nov-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzEwNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>439 KB</td> </tr> <tr> <td>70</td> <td>Advertisement of ADI</td> <td>2018-Sep-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE0OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>425 KB</td> </tr> <tr> <td>71</td> <td>Constitution of State level Committee Regarding the Faulty ASR HIP Implant manufatured by M/s DePuy International Ltd U K</td> <td>2018-Sep-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzEzNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>352 KB</td> </tr> <tr> <td>72</td> <td>Office Order </td> <td>2018-May-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDA3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>265KB</td> </tr> <tr> <td>73</td> <td>Office Order</td> <td>2018-May-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDA5'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>245KB</td> </tr> <tr> <td>74</td> <td>Office Order regarding Public Relations Office at CDSCO (HQ) </td> <td>2018-Apr-23</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDEy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>245KB</td> </tr> <tr> <td>75</td> <td>Grouping Guidelines for Medical Devices Applications</td> <td>2018-Mar-16</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA1'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1,984kb</td> </tr> <tr> <td>76</td> <td>Office Order regarding Setting up of Public Relation Office at CDSCO (HQ) dated 07.3.2018</td> <td>2018-Mar-07</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDE4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>310KB</td> </tr> <tr> <td>77</td> <td>Office Corrigendum regarding Drugs Inspector's transfers in CDSCO</td> <td>2018-Feb-20</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI0'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>204KB</td> </tr> <tr> <td>78</td> <td>Order regarding Drugs Inspector's/Technical officer's transfers</td> <td>2018-Feb-20</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDIy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>931KB</td> </tr> <tr> <td>79</td> <td>Report of the Expert Committee to address the Issue of Faulty ASRâ¢ Hip Implants (Dr. Arun Kumar Aggarwal, The Chairman of the Expert Committee)</td> <td>2018-Feb-19</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>34851 KB</td> </tr> <tr> <td>80</td> <td>Office order regarding Grievance Redressal in CDSCO (HQ)</td> <td>2018-Feb-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>304KB</td> </tr> <tr> <td>81</td> <td>Notice regarding application were called for engagement of Research Scientist medical Device and Diagnostic on contractual basis under CDSCO H/Q</td> <td>2018-Jan-23</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDMx'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>606KB</td> </tr> <tr> <td>82</td> <td>Office order regarding appointed to offciate on ad-hoc basis on the post of ADC(I) </td> <td>2018-Jan-22</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDMz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>875KB</td> </tr> <tr> <td>83</td> <td>Office Memorandum regarding Filling up the post of DIs(Medical Devices) in CDSCO on deputation basis</td> <td>2018-Jan-22</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDMy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>823KB</td> </tr> <tr> <td>84</td> <td>NOTICE - regarding Draft guidance documents on essential principles for safety and performance of medical devices as per medical devices rules 2017</td> <td>2018-Jan-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDU3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1.16MB</td> </tr> <tr> <td>85</td> <td> Office order regarding SUGAM Portal of CDSCO</td> <td>2017-Dec-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDM3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>180KB</td> </tr> <tr> <td>86</td> <td>Office order regarding appointment of CPIO and Applellate Authority u/s 5 of RTI 2005 for RDTL Chandigarh </td> <td>2017-Dec-05</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDM4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>308kb</td> </tr> <tr> <td>87</td> <td>Notice Regarding Classification of Medical devices and in Vitro diagnostic Medical devices under the provisions of the Medical Devices Rules 2017</td> <td>2017-Nov-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTkyMw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>4,147 KB</td> </tr> <tr> <td>88</td> <td>Office Memorandum regarding clarification for dealing with impoted consignments of Medical Devices and IVDs held at the port offices</td> <td>2017-Oct-31</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDQz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>665KB</td> </tr> <tr> <td>89</td> <td>NOTICE regarding Not of Standard Quality Combipack ABD </td> <td>2017-Sep-15</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDQ3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>72.8KB</td> </tr> <tr> <td>90</td> <td>NOTICE regarding not of Standard Quality of Mediclone D</td> <td>2017-Sep-15</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDQ4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>59.9KB</td> </tr> <tr> <td>91</td> <td>NOTICE - regarding Setting up of GST helpdesk in CDSCO (HQ) </td> <td>2017-Jul-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDU5'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>182KB</td> </tr> <tr> <td>92</td> <td>NOTICE - regarding availability of essential mediines following implementation of GST </td> <td>2017-Jul-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDYx'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>637KB</td> </tr> <tr> <td>93</td> <td>corrigendum with respect to revised specification/criteria of acceptance for quality test for Ant-HCV Rapid Kit </td> <td>2017-Jul-12</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDYw'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>41.9KB</td> </tr> <tr> <td>94</td> <td>Notice Order regarding draft classification of Medical Devices and IVDs</td> <td>2017-Jun-29</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDY1'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1.83MB</td> </tr> <tr> <td>95</td> <td>Notice Order regarding Streamlining the regulatory procedures</td> <td>2017-Jun-27</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTA4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>212KB</td> </tr> <tr> <td>96</td> <td>Notice Order regarding Oseltamivir and Zanamivir</td> <td>2017-Jun-22</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDY4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1.14MB</td> </tr> <tr> <td>97</td> <td>Notice Order regarding address the grievances/ appeals</td> <td>2017-Jun-22</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDY3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>642kb</td> </tr> <tr> <td>98</td> <td>Notice regarding Draft SOP for handling of NSQ samples </td> <td>2017-Jun-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDcw'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>5.57KB</td> </tr> <tr> <td>99</td> <td>Notice regarding Online application for registration of Notified Body through SUGAM Portal under medical Devices Rules 2017</td> <td>2017-May-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDcz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>279KB</td> </tr> <tr> <td>100</td> <td>Office Memorandum permission to affix the sticker indicating date of manufacture and Date of expiry with respect of Medical Devices under the provision of Drugs and Cosmetic Rules</td> <td>2017-May-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDc1'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>60.1KB</td> </tr> <tr> <td>101</td> <td>NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi</td> <td>2017-Apr-24</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDU4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>37.5KB</td> </tr> <tr> <td>102</td> <td>Notice regarding Meeting for the registration of notified body through online portal</td> <td>2017-Apr-07</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDc4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>542KB</td> </tr> <tr> <td>103</td> <td>Notice regarding Issue of Updating the Schedule H of the Drugs and Cosmetics Rules 1945 </td> <td>2017-Mar-31</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDgw'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>250KB</td> </tr> <tr> <td>104</td> <td>Public Notice regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse</td> <td>2017-Mar-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDgx'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>213KB</td> </tr> <tr> <td>105</td> <td>Office memorandum regarding Strict regulatory control over manufacture, sale and distribution of oxytocin and to curb its misuse </td> <td>2017-Mar-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDgy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>287KB</td> </tr> <tr> <td>106</td> <td>Notice regarding Regulatory approvals relating to combination products for HIV Hepatitis B&C which are recommended for Concomitant use by WHO</td> <td>2017-Mar-20</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDgz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>432KB</td> </tr> <tr> <td>107</td> <td>Notice regarding Finalization of audit fee of Notified Bodies under Medical Devices Rules,2017</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>9728 KB</td> </tr> <tr> <td>108</td> <td>Notice regarding Medical Devices Rules,2017 Notification No. 78E</td> <td>2017-Feb-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDkz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>23.0KB</td> </tr> <tr> <td>109</td> <td>Notice regarding Streamline the grievance </td> <td>2017-Feb-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDky'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>362KB</td> </tr> <tr> <td>110</td> <td>List of clarifications and NOC issued from 2011 to 2017</td> <td>2017-Jan-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>901kb</td> </tr> <tr> <td>111</td> <td>Extending the validity of Free Sale certificate for notified medical devices</td> <td>2016-Apr-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTY2'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>650KB</td> </tr> <tr> <td>112</td> <td>Notice regarding Launching of Online portal SUGAm for import and registration of Medical Devices and Diagnostics</td> <td>2016-Mar-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTk3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>673KB</td> </tr> <tr> <td>113</td> <td>Acceptance Criteria for test and Examination of Blood Glucose Test Trips and Analyzer based glucose reagen</td> <td>2016-Feb-16</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTY0'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>54KB</td> </tr> <tr> <td>114</td> <td>Clarification for import of in Bulk form in Sutures</td> <td>2015-Dec-08</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA4'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>258kb</td> </tr> <tr> <td>115</td> <td>Latter to All state/UT Drugs Controllers regarding Availabilty of diagnostic Kits, Drugs used for swine Flue </td> <td>2015-Feb-14</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=Njc3'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>294KB</td> </tr> <tr> <td>116</td> <td>Office Order dated 09.07.2014 Clarification for regulation of Medical devices under the provision of Drugs and Cosmetics Acts and Rules</td> <td>2014-Jul-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzE0'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>437KB</td> </tr> <tr> <td>117</td> <td>Clarification reg NOC to import of diagnostics kit or reagent for ROU dated 13.07.2012</td> <td>2012-Jul-13</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=Mjk5OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>201 KB</td> </tr> <tr> <td>118</td> <td>Regulation of import and manufacture of certain medical devices covered under the Categories of notified Medical devices</td> <td>2012-Mar-05</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>74 KB</td> </tr> <tr> <td>119</td> <td>REPRODUCTIVE & UROLOGY ORDER</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>123 KB</td> </tr> <tr> <td>120</td> <td>MISCELLANEOUS ORDER</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMyMA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>118 KB</td> </tr> <tr> <td>121</td> <td>ORTHOPAEDIC ORDER</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxNw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>127 KB</td> </tr> <tr> <td>122</td> <td>GENERAL ORDER</td> <td>2012-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>140 KB</td> </tr> <tr> <td>123</td> <td>Clarification for import of pre-filled syringe</td> <td>2011-Nov-07</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA5'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>282kb</td> </tr> <tr> <td>124</td> <td>Clarification on regulation of staplers</td> <td>2011-Oct-04</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjEw'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>54kb</td> </tr> <tr> <td>125</td> <td>MDAC of Reporductive and Urology</td> <td>2011-May-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>123 KB</td> </tr> <tr> <td>126</td> <td>MDAC of Orthopedic</td> <td>2011-May-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>127 KB</td> </tr> <tr> <td>127</td> <td>MDAC Dental</td> <td>2011-May-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1NQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>119 KB</td> </tr> <tr> <td>128</td> <td>MDAC Miscellaneous Devices</td> <td>2011-May-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>118 KB</td> </tr> <tr> <td>129</td> <td>MDAC of General Expert Pool</td> <td>2011-May-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>140 KB</td> </tr> <tr> <td>130</td> <td>MDAC Cardiovascular order dated 10 May 2011</td> <td>2011-May-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE0OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>129 KB</td> </tr> <tr> <td>131</td> <td>MDAC of Ophthalmic</td> <td>2011-May-10</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>126 KB</td> </tr> <tr> <td>132</td> <td>CARDIOVASCULAR ORDER</td> <td>2011-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>129 KB</td> </tr> <tr> <td>133</td> <td>OPHTHALMIC ORDER</td> <td>2011-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>126 KB</td> </tr> <tr> <td>134</td> <td>DENTAL ORDER</td> <td>2011-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMxNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>119 KB</td> </tr> <tr> <td>135</td> <td>List of Notified Medical devices</td> <td>2010-Apr-20</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE1Ng=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>85 KB</td> </tr> </tbody> </table> </div> </div> </div> <div class="tab-pane fade show" id="tab4"> <div class="wrap-appr"> <div class="col-md-12 col-sm-12 table-responsive"> <table class="w-100 table table-bordered bg-head table-striped example3" data-limit-navigation="5" data-page-size="10" data-filter="#filter" data-filter-text-only="false" id="example3"> <thead > <tr > <th>S.no</th> <th>Title</th> <th>Release Date</th> <th>Download Pdf</th> <th>Pdf Size</th> </tr> </thead> <tbody> <tr> <td>1</td> <td>02.06. 2023 G.S.R 409(E) Medical Devices</td> <td>2023-Jun-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTAzMjg='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1157 KB</td> </tr> <tr> <td>2</td> <td>MDR_G.S.R. 777(E) dt_14.10.2022_exemption of non sterile and non measuring Class A medical devices from licensing regime</td> <td>2022-Oct-14</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTAwMzE='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1102 KB</td> </tr> <tr> <td>3</td> <td>G.S.R. 777(E) 14 Oct 2022 Final notification for exemption of non sterile and non measuring Class A medical devices from licensing regime</td> <td>2022-Oct-14</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTEyMw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1020 KB</td> </tr> <tr> <td>4</td> <td>GSR 754 (E) 30-09-2022 sale of medical device retail and wholesale</td> <td>2022-Sep-30</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA4MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1348 KB</td> </tr> <tr> <td>5</td> <td>2022.09.28_S.O._4573(E)_Notification for designation of RDTL Chandigarh also as CMDTL as per MDR 2017</td> <td>2022-Sep-28</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA1MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1291 KB</td> </tr> <tr> <td>6</td> <td>2022.09.20_Draft_GSR 710(E)_Exemption of certain Class A medical device from licensing regime</td> <td>2022-Sep-20</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA0MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1300 KB</td> </tr> <tr> <td>7</td> <td>2022.08.02_S.O. 3739(E)_Notification of Medical Devices Testing Officer for CMDTL</td> <td>2022-Aug-02</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODg2Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1126 KB</td> </tr> <tr> <td>8</td> <td>2022.06.15_Final GSR 450(E)_To amend Fourth Schedule wrt TSE or BSE certificate under MDR</td> <td>2022-Jun-15</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODYxOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1348 KB</td> </tr> <tr> <td>9</td> <td>2022.05.18_Final GSR 356(E)_Insert rule 43A for Suspension and cancellation of license in MDR 2017</td> <td>2022-May-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODQ4OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1137 KB</td> </tr> <tr> <td>10</td> <td>2022.02.09_Draft GSR 104(E)_Regulation of sale of medical devices via registration of premises under MDR, 2017</td> <td>2022-Feb-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODEyNA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1520 KB</td> </tr> <tr> <td>11</td> <td>2022.02.09_S.O. 553(E)_ Stockpiling of new drug under phase 3 of clinical trial_NDCTR,2019</td> <td>2022-Feb-09</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODEyNQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1106 KB</td> </tr> <tr> <td>12</td> <td>2022.01.18_Final GSR 19(E)_Amendment in rules 19B, 19C,19D &19E of MDR 2017</td> <td>2022-Jan-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODEzOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1557 KB</td> </tr> <tr> <td>13</td> <td>2021.12.31_Final GSR 918(E)_Amendment of rnule 46 of MDR for Unique Device Identification</td> <td>2021-Dec-31</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODEzOQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1355 KB</td> </tr> <tr> <td>14</td> <td>S.O. 3722(E) dated 21.10.202</td> <td>2020-Oct-21</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjU5OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1215 KB</td> </tr> <tr> <td>15</td> <td>S.O. 648(E) dated 11.02.2020_ Medical Device Definition</td> <td>2020-Feb-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>902 KB</td> </tr> <tr> <td>16</td> <td>G.S.R. 102(E)_dated 11.02.2020_ Registration of certain medical devices</td> <td>2020-Feb-11</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1192 KB</td> </tr> <tr> <td>17</td> <td>2019.10.18_G.S.R. 797(E)_Registration of Certain Medical Devices_chapter-IIIA</td> <td>2019-Oct-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTE4MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>370 KB</td> </tr> <tr> <td>18</td> <td>2019.03.18 Final G.S.R.224(E) Amendment in Environmental requirements for mfg. of Medical Devices Annexure- A of the Fifth Schedule of MDR, 2017</td> <td>2019-Mar-18</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI1OQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>303 KB</td> </tr> <tr> <td>19</td> <td>S.O.5980(E)-03-12-2018</td> <td>2018-Dec-03</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE0Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>279 KB</td> </tr> <tr> <td>20</td> <td>S.O. 2237(E) </td> <td>2018-Jun-01</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTY2Nw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1,752KB</td> </tr> <tr> <td>21</td> <td>6th October 2005 (SO 1468(E)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI3Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>69 KB</td> </tr> <tr> <td>22</td> <td>17th March 1989 GSR 365 (E)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI3MA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>166 KB</td> </tr> <tr> <td>23</td> <td>27th August 2002 GSR 601 (E)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI3MQ=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>217 KB</td> </tr> <tr> <td>24</td> <td>24th October 2013 (GSR 703 (E)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI3NA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>558 KB</td> </tr> <tr> <td>25</td> <td>S.O. 2237(E)_Notification on Central Medical Device Testing Laboratory under MDR 2017</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMyOA=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1752 KB</td> </tr> <tr> <td>26</td> <td>7th October 2005 (GSR 627 (E)</td> <td>2017-Feb-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzI3Mw=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>66 KB</td> </tr> <tr> <td>27</td> <td>Medical Device Rule 2017 - GSR 78(E) Dated- 31.01.2017</td> <td>2017-Jan-31</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzMzNg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>3029 KB</td> </tr> <tr> <td>28</td> <td>GSR 640 (E) dated 29.06.2016 regarding Schedule - MIII - Requirement of QMS for Medical Devices</td> <td>2016-Jun-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzM0Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>484 KB</td> </tr> <tr> <td>29</td> <td>G.S.R 690(E)</td> <td>2014-Sep-25</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk5'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>222kb</td> </tr> <tr> <td>30</td> <td>S.G 3793(E)</td> <td>2013-Dec-23</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAw'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>135kb</td> </tr> <tr> <td>31</td> <td>G.S.R 627(E)</td> <td>2005-Oct-07</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAx'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>66kb</td> </tr> <tr> <td>32</td> <td>S.O 1468(E)</td> <td>2005-Oct-06</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAy'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>69kb</td> </tr> <tr> <td>33</td> <td>GSR_601_E_27-08-2002</td> <td>2002-Aug-27</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzE0Mg=='><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1336 KB</td> </tr> <tr> <td>34</td> <td>G.S.R. 600(E)</td> <td>2002-Aug-07</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjAz'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>1336kb</td> </tr> <tr> <td>35</td> <td>G.S.R. 365(E)</td> <td>1989-Jun-17</td> <td><a href='/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjA0'><i class="fa fa-file-pdf-o" style="color: red"></i></a></td> <td>166kb</td> </tr> </tbody> </table> </div> </div> </div> </div> </div> </div>  </div>  </div> </section>  </div>  <div class="push"></div> </div> <div class="wrap-f"> <footer> <div id="footer1" 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