HSA | Guidance documents for medical devices

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href="/about-us">Who we are</a> </li> </ul> </div> <div class="hsa-header__sidebar__extender"> <div class="hsa-header__sidebar__extender__column-1"> <div data-label="2fa7c40c-9b3d-4679-b2ab-79d113f9f0e8" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Medical devices</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/regulatory-overview" data-guid="b24e2731-43c1-4cc4-ae92-b4e0b32848f6"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="7ede8f61-ff1c-4c69-a6a4-df1fd414c539"> Register your device </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/change-notification" data-guid="fbe0159e-5824-4ac5-8823-02cf9b80a768"> Changes to registered devices </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="30939644-bd18-43b4-b6d1-de9a663ccdb4"> Dealer's licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/certificates" data-guid="5696f1b9-bfb0-4c99-ab60-799be24a96ac"> Free Sale Certificate and Export Certificate </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/adverse-events" data-guid="e902d3d9-c6a2-46b8-adb3-15b4496de04d"> Report adverse events </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="668d06f0-a4bb-4de1-8caf-df59aed1ed04"> Field Safety Corrective Action reporting </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/clinical-trials" data-guid="e074cca9-2d2b-48c4-985d-83833e4b4f72"> Clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/consultation-schemes" data-guid="e0728bc1-d7f2-4760-b501-7fb8a0104633"> Consultation schemes </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/advertisements-promotions" data-guid="c575786f-fe89-4ecf-836d-06037d6d227f"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/personal-import" data-guid="78b688d0-a782-4285-bedf-c9644c618ac3"> Bringing personal medical devices into Singapore </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/covid-19-standards-resources-for-essential-medical-devices" data-guid="d68b9ba1-c40b-49de-80c9-248689c8ee1c"> COVID-19: Standards Resources for Essential Medical Devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/digital-health" data-guid="faa4c7e8-8fa5-4907-bba0-cf7323541845"> Digital Health </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="27da00ef-00ec-4790-9d18-6916d678ecfd"> International collaboration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/standards-for-medical-devices" data-guid="e78eb821-29c2-4555-a644-bd437bffb1f8"> Standards for Medical Devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/guidance-documents" data-guid="de28c215-08d1-44a5-af83-ef489b2105fe"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/fees" data-guid="557d7609-331a-47bd-95e5-d4e9fe4cbdac"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="02a741e1-7ebb-4de5-aa7a-bfeafb1a2f0f" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Therapeutic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/overview" data-guid="2cd88bdd-846b-4d7d-ba3f-58efc47f49d6"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="1bb793b7-6ebc-4614-ab26-f3486e8d47b8"> Register your product </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="382c3665-f125-4dbd-aa45-33855a4edecc"> Apply for post-approval variation </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="c7d36f32-24f2-4341-852f-879820bd2f95"> Reclassify your product </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="610292f3-004d-4e6e-8995-c25be4a1273b"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retain-cancel-or-transfer-therapeutic-product-registrations" data-guid="51a7ad22-338f-49ae-9336-c385884fdd1f"> Retain, cancel or transfer product registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/rmp" data-guid="73570827-4fc4-4805-b778-0c6ed71d542c"> Risk management plan requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/adverse-events" data-guid="dfc7cd0c-0dd2-4789-bc57-430dce08bca8"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/defect-reporting-recall" data-guid="1e2b6d48-7d73-43f6-ae20-d64c8dcd364b"> Report or recall defective products </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="25fc1ebe-32a2-4170-ae07-309d697d35e5"> Retail pharmacy licensing </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="efa56797-fabe-4d38-810f-4cd825fa6486"> Clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/product-consultation" data-guid="35dd4be5-4f72-4acb-9b50-bb5d5fb283e4"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/advertisements" data-guid="8ff3017a-0e57-49a4-8db1-dfa95bf2a0c8"> Advertisements and promotions </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="c28d32cb-4d78-48ec-bb2a-e42249225222"> CPP and SLS </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="669e5508-668c-45fb-b768-d34e6d5fef95"> International collaboration </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="9abfc5d0-f746-49d7-8c7e-f71d93c182a9"> Medicines quality and compliance monitoring </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/approvals-and-post-reg-actions" data-guid="ef526abe-209f-4f29-bb86-785b2df26818"> Listing of approvals and post-registration actions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/guidance-documents" data-guid="62872c1e-38a5-42f9-a2c8-a8a83702109b"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/fees" data-guid="1579b0f9-3040-487c-b455-9d1225222d98"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="246268ec-0756-45b3-bb95-b3c4a6da2846" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Health supplements</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/overview" data-guid="84b7033f-f384-49c1-9fad-6fce15c92285"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/vns" data-guid="7ec10a91-7ddf-4814-8b8f-1a0e8b12767f"> Voluntary Notification of HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/list-of-notified-health-supplements-and-traditional-medicines" data-guid="3cd877f0-bcc4-43b5-9908-9a514e8c844e"> List of Notified HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/claims" data-guid="a689b476-c59b-42ee-8be8-5935bafc7a00"> Health supplement claims </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/advertisements-and-promotions-of-medicinal-products" data-guid="7b38c6d6-debf-4912-a85b-7effbd0542d1"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/adverse-events-reporting-of-health-supplements" data-guid="d1d02256-9c76-4627-8061-7f0f2e96945c"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/health-supplements/international-collaboration-for-complementary-health-products" data-guid="44cb8d61-8291-4751-8aa5-4a5e4140e007"> International collaboration </a> </li> </ul> </div> <div data-label="9895f1ad-a865-4b50-89e5-98b27e3af020" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Traditional medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/overview" data-guid="0271bb00-51f7-429b-9c70-6b0184385233"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/vns" data-guid="478b3953-40f7-43d2-84f0-f90f43d7b780"> Voluntary Notification of HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/list-of-notified-health-supplements-and-traditional-medicines" data-guid="de01dba9-e076-4233-81ed-3f3cb07476c4"> List of Notified HS and TM </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/advertisements-and-promotions-of-medicinal-products" data-guid="6ab913a0-34c6-4c0e-98c4-575dfc1f56cf"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/report-adverse-events" data-guid="8f86ce68-926e-491f-ad7b-b1867f32353e"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/traditional-medicinal-materials" data-guid="d18617f7-d012-49c3-93b0-f297a10a4c78"> Traditional medicinal materials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/traditional-medicines/international-collaboration" data-guid="24d76262-844a-413d-a536-e3129d9e5122"> International collaboration </a> </li> </ul> </div> <div data-label="7680548f-411c-4b43-8fe7-4da5f27833c8" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Chinese proprietary medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/overview" data-guid="cd89cf57-15f3-4d97-b828-84e95aff4990"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="dae1b05b-8161-4833-95a5-14b6eda06caf"> Product listing </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="17eb371c-7d1b-4ff8-8586-9190c021a006"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/export" data-guid="2bbcbc75-0270-469e-a292-a0036fc4d414"> Free Sale Certificate </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/advertisements-medicinal-products-tmm" data-guid="0a97d25a-e690-4971-92f6-32e0da1303cc"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/adverse-events" data-guid="96939874-b945-4831-92e2-d2134f573983"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/traditional-medicinal-materials" data-guid="257986ec-60d1-48bc-a72a-36362f874a4b"> Traditional medicinal materials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/international-collaboration-for-complementary-health-products" data-guid="f17d68c4-d044-43c9-915a-486f8f6c7c32"> International collaboration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/fees" data-guid="334e5c37-3e3f-400d-acfe-f7dbdf9df385"> Fees and Turnaround time of Chinese Proprietary Medicines </a> </li> </ul> </div> <div data-label="6fb37491-3203-4b13-a276-7bbef8b824a9" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Cosmetic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/overview" data-guid="bd161848-e281-4eb4-88eb-d50718fab34f"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="b6ca1f1f-75c5-4537-be36-0505ef1d1b42"> Cosmetic product notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/asean-cosmetic-directive" data-guid="75199b88-06c7-4911-ade6-c0fae6b5beb1"> ASEAN Cosmetic Directive </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/good-manufacturing-practice" data-guid="41295286-4d99-4719-90a6-80e36db75b62"> Good Manufacturing Practice certification for cosmetic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/report-adverse-events-of-cosmetic-products" data-guid="08ab8f6c-5867-4cde-8a64-29c2b44ee781"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/fees" data-guid="fe44fb88-0d08-4e8c-84cd-7dd749b82b1b"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="4617683f-c959-4829-b97a-b3cdb93ccb68" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco regulation</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/overview" data-guid="e9dbbf4f-2d76-4024-a8e8-31f55492d7b4"> Overview of tobacco control </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="25429b7c-80af-4fa8-bf40-70f62681eb5f"> Tobacco licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/suspended-revoked-licences" data-guid="dac2e9d7-81e1-4a0b-8322-bb68908885de"> List of suspended and revoked licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/report" data-guid="81d704aa-5059-46a4-97ac-1e2ed7577345"> Report tobacco-related offences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/fees" data-guid="cfd6e504-5352-4c4f-a428-21530c94e642"> Fees and turnaround time </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/tobacco-retailer-educational-video-and-quiz" data-guid="a910f388-93e3-4ba7-962b-3fee461fbc95"> Tobacco retailer educational video and quiz </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/vaping-enforcement" data-guid="6ac998c5-a57a-4820-b755-97d5a1a12702"> Vaping enforcement </a> </li> </ul> </div> <div data-label="979de975-13ac-4941-8c9c-1527e7dde9d3" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CTGTP</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/regulatory-overview" data-guid="37e4cfd4-8234-40a4-9c7d-e81b349126b3"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/class1-notification" data-guid="b3c9c340-ad73-4183-a44a-d649ab1b5785"> Class 1 CTGTP notification </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="8bf23c04-8c49-4780-b303-542f375a2b39"> Register a Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/variation" data-guid="9a0f3708-b4df-4965-a393-603cb816fbe3"> Variation applications </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-notice" data-guid="584b3b0a-e144-49e2-975b-079e228e6c8d"> Dealer's notice </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f1513b1d-d5e5-4eb6-aa96-ff39b5c36981"> Dealer's licensing and certification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/rmp" data-guid="751614d8-2439-42e2-af1e-cf1c4317b485"> Risk management plan requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/adverse-events" data-guid="be485ef9-c825-45dc-83d6-ba0d7b0824f8"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/defect-and-recalls" data-guid="49abb8dc-d30b-4a8b-9413-5cb6abd35447"> Report or recall defective products </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="0baf57d7-e63c-4c85-b702-a326bda7a2c4"> Clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/product-consultation" data-guid="f583337c-a42b-4305-a0a1-0a4a925ecfcb"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/advertisements" data-guid="d191cdf2-3199-4595-938d-cc13590e89c0"> Advertisements and promotions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/cpp" data-guid="adaa0f41-df0b-4b7f-9eb2-6f7fc35c513e"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/duties-and-obligations" data-guid="bc235ae3-678e-4ae8-a40b-74d2e9bb8fc7"> Duties And Obligations </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/guidance-documents" data-guid="c6ee0f87-ea10-46ce-b7e4-c624336c1a70"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/fees-and-TAT" data-guid="b62d4bbb-97e6-403a-bd29-9ab4b83a94b1"> Fees and turnaround time </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/notified-ctgtp" data-guid="92827969-ea7a-4e98-8c47-7ebe73ff323f"> Notified Class 1 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/ctgtp-register" data-guid="0146ad7a-a482-4a40-9e06-ac39f3ab4e62"> Register of Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/register-of-cell-tissue-or-gene-therapy-products-licensees" data-guid="face7927-ccdd-4a6a-85a0-212dba24d693"> Register of Licensed CTGTP Importers, Wholesalers and Manufacturers </a> </li> </ul> </div> <div data-label="09c13846-b094-41b6-94ef-724cbfda293a" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Bringing personal medications into Singapore</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/overview" data-guid="ef3465c3-1f30-4ff7-8cf0-1783ac3266b0"> Regulations for bringing in personal medications </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/check-requirements" data-guid="5ae34c46-f9c8-475f-871d-fcd85e3e8460"> Check medication requirements </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/personal-medication/submit-application-for-approval-to-bring-in-personal-medications-(new)" data-guid="65a1f011-4fc7-4b84-8e1f-7863289bf53b"> Submit application for approval to bring in personal medication </a> </li> </ul> </div> <div data-label="0b00adf2-a40d-4ea3-bc12-b0aaf14c0ab5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Active ingredients</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/regulatory-overview" data-guid="dcb8d11f-bba3-4ff4-bfb3-981179948c72"> Regulatory Overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f9b17351-9e31-4cbe-9368-89990285d3ab"> Licensing and certification of importers and wholesalers </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="3115698c-9584-4b2a-980e-61f2f1ddce20"> Licensing and certification of manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/certificate-of-a-pharmaceutical-product" data-guid="f04be9be-c430-420a-ac52-f0305b04671c"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/requirements-for-active-ingredients-notification" data-guid="a48c2a91-e94f-461e-b488-154280aa1155"> Active ingredients used in Clinical Research/Clinical Trial </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/guidance-documents" data-guid="9822345f-a5dc-463f-ad36-02059ab63caa"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/fees-and-turnaround-time" data-guid="98f5142a-bfed-475e-9e1e-eeacae915249"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="3864b786-c4b7-4761-93f5-8f0738454fc0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/overview" data-guid="e06cd0df-ef61-43ec-9d14-4d516cfbc560"> Regulatory overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="8c5c2c4d-0e40-4323-a87e-b4a3f03a4c2b"> CTA, CTN or CTC submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/crm-notification" data-guid="4cd0dc10-3e32-4dd6-8566-eebb43a02b40"> Submit a CRM notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/good-clinical-practice" data-guid="6eda14e6-f44e-4eb5-9a9f-7946ec0df452"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/adverse-events" data-guid="9d1d8955-7769-4a88-ae31-f21375fc837d"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/innovation-office" data-guid="a970778f-fe31-451c-8bb4-11be032be3d1"> Innovation Office </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="525bb14a-8f6c-4ea3-920d-8126125f5443"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/participating" data-guid="d8ddf9e6-4343-49ed-8bb7-322d59f9df25"> Participating in clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/regulatory-guidances" data-guid="43b28bbc-936f-4bab-8b59-cab37069b687"> Guidance documents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/clinical-trials-register" data-guid="b5fb8906-c682-4bda-839a-9043ec9e3a72"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/statistics" data-guid="47ae6c12-8e21-4b6c-9632-2a9ec584dea7"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="bddf8db1-ce0e-497d-ae77-857efec4566e" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Controlled drugs and psychotropic substances</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="2dfb1261-9d74-487f-b59a-8f0c75330def"> Controlled drugs </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/psychotropic-substances" data-guid="9368ffd0-861d-42af-a664-3128948d061c"> Psychotropic substances </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/restricted-substances" data-guid="3b4abff4-06ed-4895-8031-b263d2d1f16a"> Restricted substances </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/fees" data-guid="8f70fe0f-d8f7-4565-9dcc-acec2ff00efd"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="e5c77d76-09c8-40ba-ae32-8960fd5212a7" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Poisons</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/overview" data-guid="0a0b16ae-b87a-464e-afbc-6318a4d0078e"> Overview of Form A Poisons Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/apply" data-guid="eb91b4aa-a3f3-4535-a294-1006eb31b074"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/amend" data-guid="0e4a341a-ee1c-4dfa-9079-0d8fb2835567"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/renew" data-guid="bc36d7bb-a0fe-4558-969f-a56a849c1d30"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/poisons/fees" data-guid="fe3dc090-03e8-4b05-88ee-47aa717da9b9"> Fees and turnaround time </a> </li> </ul> </div> <div data-label="de6b77c3-03f4-4b75-8f1a-fe28c36f7fd0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Topical antiseptics</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/topical-antiseptics/overview" data-guid="b0bda773-e4cd-43d6-801c-5910a6addc0d"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/topical-antiseptics/classification" data-guid="c957249f-9b1c-4e2a-b196-d791b90fc6a0"> Topical antiseptics classification guide </a> </li> </ul> </div> <div data-label="1b050871-6f13-424b-9169-c5f607c45b70" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">COVID-19 regulatory information and consumer advisories</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/covid-19-information-and-advisories/hsa_review_swiss_study" data-guid="fb1a705c-f655-472e-8732-eba57bedd7c6"> HSA's review of Swiss study </a> </li> </ul> </div> <div data-label="5dab3d87-61e1-4634-8e84-6de88ede8ef0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">E-services</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/e-services/eGIRO" data-guid="720bfe3e-013c-4a09-9e08-75de89fb0f39"> eGIRO </a> </li> </ul> </div> <div data-label="bd4d47da-3264-48f7-b788-f7ec3192566a" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Consumer safety</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="a42d2730-7835-4ae5-bf0e-f23171a903e5"> Articles </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/consumer-safety/make-a-report" data-guid="37e114c1-1313-478a-9456-ddf438abf2a3"> Make a report </a> </li> </ul> </div> <div data-label="47b22a70-25fc-4858-a0c6-5808f105461d" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Why join HSA</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/apply" data-guid="826776c8-7652-4790-8a89-486de533b723"> Apply for a job </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/sponsorship-for-diploma-in-nursing" data-guid="b43bd040-0e61-498c-b9a9-7f4200475fcb"> Sponsorship for Diploma in Nursing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/benefits" data-guid="98fda3e9-d25c-4052-b385-b35110b6f3a3"> Employment benefits </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="adfe758d-5941-4ea6-baf1-69fa38b2a74e"> Articles </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/forensic-odontology-scholarship" data-guid="a3e7ab3f-c4cd-46a2-b1ab-89188e470964"> Forensic Odontology Scholarship </a> </li> </ul> </div> </div> <div class="hsa-header__sidebar__extender__column-2"> <div data-label="7ede8f61-ff1c-4c69-a6a4-df1fd414c539" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register your device</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/overview" data-guid="4a0a9bfd-e83f-4cac-ab82-30f548c7dfa0"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/is-it-a-medical-device" data-guid="0ddfe170-9c1e-44fc-8827-7c8a73854b0a"> Is it a medical device <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/risk-classification-rule" data-guid="f4fac194-4032-4e22-9ddc-5a0e214e4619"> Risk classification rules and factors </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/risk-classification" data-guid="2e0cc6ab-f76d-4b71-a4a9-3ab6b1fd473a"> Risk classification tool <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/requirements" data-guid="b9c4171b-7fb0-4b77-a8c8-d2479ec34896"> Registration and licensing requirements <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/identifying-md-grouping" data-guid="9dc2b5a8-f5fe-4cd2-80b1-a0af4a75a057"> Medical device grouping tool <span class="hsa-badge m-l:xs">Tool</span> </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="4ab762eb-155b-466b-8a25-82bd36c8a446"> Grouping medical devices </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f2dbc2a3-5dd0-48e9-8050-6eefb4934da4"> Registration guides </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/priority-review-scheme" data-guid="aefddcf5-7ca3-43fc-b6c7-e7783239225d"> Priority Review Scheme </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="04b8be8f-e147-47dd-89b7-56c00dd52cdc"> Special Access Routes </a> </li> </ul> </div> <div data-label="30939644-bd18-43b4-b6d1-de9a663ccdb4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/apply" data-guid="471507f9-e42c-4931-a6e0-40b8fc7e39a6"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/amend-licence" data-guid="60791d45-21e2-4661-b9bd-a9c144e51de3"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/renew" data-guid="cafdc875-fc28-4b2d-bec3-eefb3cae23e4"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/dealers-licence/good-distribution-practice" data-guid="570127a0-ec1a-4c01-8691-5c70cea0234e"> Good Distribution Practice for Medical Devices </a> </li> </ul> </div> <div data-label="668d06f0-a4bb-4de1-8caf-df59aed1ed04" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Field Safety Corrective Action reporting</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/when-to-report" data-guid="d24d93f8-8fb7-4b96-a2ca-7b5b777fe053"> When to report </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/how-to-report" data-guid="0db2317b-2b8e-47dd-8930-dbbd185b03ab"> How to report </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/field-safety-corrective-action/corrective-actions" data-guid="f5468317-a7b2-4680-9177-0a6e01b7aa7d"> Risk management </a> </li> </ul> </div> <div data-label="27da00ef-00ec-4790-9d18-6916d678ecfd" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">International collaboration</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/international-collaboration-medical-devices/imdrf" data-guid="b0404985-fb75-4ba2-9984-890a03321340"> International Medical Device Regulators Forum (IMDRF) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/international-collaboration-medical-devices/amdc" data-guid="d61db71a-7a93-46ad-a667-9fcfe7566a68"> ASEAN Medical Device Committee (AMDC) </a> </li> </ul> </div> <div data-label="1bb793b7-6ebc-4614-ab26-f3486e8d47b8" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register your product</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="87e8659d-45a2-40d7-9189-993d38a0633c"> Registration overview </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="e10dc8cc-ed64-45f7-b36b-4a3cde564f61"> Registration guides for therapeutic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/rmp" data-guid="7dd5cd91-7696-4034-9093-a95c3107c759"> RMP submission for product registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/ectd-submissions" data-guid="7b957570-e4b0-4284-8943-8d8071370815"> eCTD submissions for Therapeutic Products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/summary-reports-of-benefit-risk-assessment" data-guid="187939d4-5a68-4657-a077-e9d00bc5f99c"> Summary Reports of Benefit-Risk Assessment </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="6e925ab4-a2e4-4933-8edc-d51e50dafe86"> Special Access Routes (SAR) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/gmp-conformity-assessment" data-guid="171464e4-b6af-4d89-a1b6-c091f73f04a6"> GMP conformity assessment of overseas manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/vaccine-lot-release" data-guid="a7da8b5f-b675-48ea-ae81-fe833f29c17a"> Lot release for imported vaccines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/pre-submission-consultation-mechanisms" data-guid="d566e8c5-3a97-48bd-8d98-03674add1d28"> Pre-submission Consultation Mechanisms </a> </li> </ul> </div> <div data-label="382c3665-f125-4dbd-aa45-33855a4edecc" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Apply for post-approval variation</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/overview" data-guid="7740ca55-114c-40cc-b6b3-e0c70fe2a1fd"> Overview of variation application types </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="81f2aeb5-71fc-4437-bcbe-363566451aa3"> Major variation (MAV-1) application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/major-variation-(mav-2)-application" data-guid="6125cd60-e055-4946-a956-da4ee2b4002c"> Major variation (MAV-2) application </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="2309de76-0cee-4377-bc01-65f576892d9d"> Minor variation (MIV) application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv-tool" data-guid="4e9c7bc2-7929-421d-a639-ac4254fdc3b2"> Minor variation (MIV) self-guided tool </a> </li> </ul> </div> <div data-label="c7d36f32-24f2-4341-852f-879820bd2f95" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Reclassify your product</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/apply" data-guid="e17c9ffe-34d9-4e3d-9b76-f8928b998559"> Apply for reclassification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/gsl-preparations" data-guid="d0881b89-7e49-44cc-abbd-9c82ff224ce0"> Preparations allowed as General Sale List </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/reclassification/list-of-reclassified-medicines" data-guid="3f4cdc7d-b9d6-44c4-baae-30ef723ff6c7"> List of reclassified medicines </a> </li> </ul> </div> <div data-label="610292f3-004d-4e6e-8995-c25be4a1273b" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/overview" data-guid="ff94a8de-0f52-4326-a3d0-904f94453385"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/apply" data-guid="acb36be4-f93e-43f3-9319-70da968ad961"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/amend" data-guid="899be1f3-552e-4269-99fe-a7615d0e9716"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/renew-cancel" data-guid="b093e7ef-4fe0-46e5-bcff-0f8c85b4e22a"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/gmp-gdp" data-guid="1a2c9571-60d0-4865-8bf1-46344bccb039"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="32be46d4-2acb-4aef-8f28-ebb7fb04cd48"> Certification of local dealers </a> </li> </ul> </div> <div data-label="25fc1ebe-32a2-4170-ae07-309d697d35e5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Retail pharmacy licensing</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/overview" data-guid="846633be-094f-4199-b920-c6531091efc8"> Overview of pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/apply" data-guid="f245d777-06aa-4348-a351-b85487c9ce55"> Apply for a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/amend" data-guid="1584bcc1-9336-4aa3-961a-d1c3f0032337"> Amend a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/renew" data-guid="0353546c-97e6-4d66-85c5-fe1e53963535"> Renew or cancel a pharmacy licence for a retail pharmacy </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/compounding" data-guid="60098304-7263-4df6-a7c5-174b08dd82c0"> Compounding of therapeutic products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/medicines-vending-machine" data-guid="7f972414-5cef-49a6-a1fd-f7ed0e4af21c"> Supply of medicines via vending machine </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/retail-pharmacy-licence/supply-of-registered-therapeutic-products-through-e-pharmacy" data-guid="828f1524-09e6-4ff9-ac6e-b088ec682eb6"> Supply of registered therapeutic products through e-pharmacy </a> </li> </ul> </div> <div data-label="efa56797-fabe-4d38-810f-4cd825fa6486" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/regulatory-overview" data-guid="e001496c-1ac0-48b7-ac9a-0a31e6d8b278"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/new-cta-or-ctn-submission" data-guid="11ae3c13-c8d9-4466-9994-18c749d46398"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/subsequent-submissions" data-guid="4d2246bc-01b6-4141-91e0-33d1223c966c"> Subsequent submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/good-clinical-practice-inspections" data-guid="553ade66-b060-42dc-baa9-56144a172d44"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/report-adverse-events" data-guid="af55b5df-88f7-4678-809f-23f4c2929fa2"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/product-development-consultation-tp" data-guid="27d291f9-ebf1-4608-8fa6-713085708fa4"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/conducting-clinical-trials" data-guid="fc3b622a-e44c-46d3-a383-a1018014ee3f"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/clinical-trials-register" data-guid="15ea591f-c5e0-4227-9b65-60994fc1f227"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/clinical-trials/clinical-trials-statistics" data-guid="23cf3a53-6367-4294-b3b8-a0421d0c845f"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="c28d32cb-4d78-48ec-bb2a-e42249225222" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CPP and SLS</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/cpp-sls/certificate-pharmaceutical-product" data-guid="4c2bb65e-ba3d-494c-9146-a1af2bf5a198"> Certificate of a Pharmaceutical Product </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/cpp-sls/statement-of-licensing-status" data-guid="38b573be-688f-4201-bae1-05c3242f820f"> Statement of Licensing Status </a> </li> </ul> </div> <div data-label="669e5508-668c-45fb-b768-d34e6d5fef95" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">International collaboration</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/access" data-guid="cd88ddb0-067d-40e3-a481-170f88c6562d"> Access Consortium </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/project-orbis" data-guid="13772e92-b28e-436c-839f-f09eb40b5550"> Project Orbis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/ich" data-guid="6fcd302f-db44-4cd2-97d7-6bd73026c319"> ICH </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/icmra" data-guid="7f94f1c1-c820-47d8-859f-4167caf86943"> ICMRA </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/ASEAN-JA" data-guid="599f42c0-3f96-4fd7-8573-2c4c888d90b1"> ASEAN Joint Assessment Procedure </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/international-collaboration/npra" data-guid="42edfb18-8f08-4681-8c21-0883fdae9267"> NPRA </a> </li> </ul> </div> <div data-label="9abfc5d0-f746-49d7-8c7e-f71d93c182a9" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Medicines quality and compliance monitoring</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="05c2a122-d4f6-4009-9b51-f2586b1974b7"> Nitrosamine impurities in medicines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/product-quality-surveillance-for-therapeutic-products" data-guid="5a600c68-25b2-4b36-884b-ac611a8fb77d"> Product Quality Surveillance for therapeutic products </a> </li> </ul> </div> <div data-label="dae1b05b-8161-4833-95a5-14b6eda06caf" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Product listing</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/apply" data-guid="d3dc33cb-72b6-455b-a4cc-bafecf04b9b4"> Apply for new product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/amend-or-cancel-product-listing" data-guid="8bf219a3-a0c3-4fa6-8e60-ac51232d435c"> Amend or cancel product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/transfer" data-guid="39b0a3ca-c3a5-4024-abd2-36f934846e6e"> Transfer product listing </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/listing/responsibilities" data-guid="b72ec571-5f19-455c-b014-d2328677ebb7"> Responsibilities of a CPM dealer </a> </li> </ul> </div> <div data-label="17eb371c-7d1b-4ff8-8586-9190c021a006" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/overview" data-guid="704fcd23-901e-42a2-86ab-b176e7424c86"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/apply" data-guid="8aa5c9d5-196a-40ee-8690-59b98a73ec58"> Apply for a Chinese Proprietary Medicine dealer's licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/amend" data-guid="eda2ba95-18d7-4d9e-94ea-44c92daadadf"> Amend a Chinese Proprietary Medicine dealer's licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/renew" data-guid="0f88825d-0b84-474c-8644-15b3717b89e2"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/gmp-gdp-standards" data-guid="44f1fe10-f257-442c-bf08-95ad59209e4d"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="ebc90580-c276-42ef-981f-bddebc7d94ba"> Certification of local dealers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/import-reexport" data-guid="7a0c8192-a52e-4086-80d3-e38c482c5e3b"> Import for re-export of Chinese Proprietary Medicines </a> </li> </ul> </div> <div data-label="b6ca1f1f-75c5-4537-be36-0505ef1d1b42" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Cosmetic product notification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/notification/submit" data-guid="9ad25a41-d9b6-4fc5-8810-f64f01981dd6"> Submit notification and re-notification </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/cosmetic-products/notification/amend" data-guid="2294cf3e-6181-44f9-a240-0f16af284bba"> Update or cancel notification </a> </li> </ul> </div> <div data-label="25429b7c-80af-4fa8-bf40-70f62681eb5f" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco licences</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="87ce5044-4900-4e2f-9bd0-9cd5157bbbc0"> Tobacco retail licence </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="62df10a0-59ba-444c-b39d-95df004b8e57"> Tobacco import and wholesale licence </a> </li> </ul> </div> <div data-label="8bf23c04-8c49-4780-b303-542f375a2b39" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Register a Class 2 CTGTP</span> <ul> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="e920cf5a-92be-4b4a-8511-94e6d69e67e6"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/gmp-comformity-assessment" data-guid="2781f73d-34ef-415d-b7df-4b427e017ace"> GMP conformity assessment of overseas manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/rmp" data-guid="4a3724cf-da51-4f02-8c3e-0c66e3880d1e"> RMP submission for product registration </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="68687f1e-54ec-4c56-97ca-8a69652bc5ca"> Special Access Routes (SAR) </a> </li> </ul> </div> <div data-label="f1513b1d-d5e5-4eb6-aa96-ff39b5c36981" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Dealer's licensing and certification</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/overview" data-guid="18185124-e2e4-4893-bc2d-24833390b73e"> Overview of dealer's licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/apply-licence" data-guid="467e86a7-6b65-4533-afe7-7bb2b6b6acf0"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/amend-licence" data-guid="bdc29b3b-28f0-4091-a3c7-e63b64d73625"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/renew-cancel-licence" data-guid="822e134d-17ba-4951-bb33-0420ca35d99b"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/gmp-gdp-standards" data-guid="04c2d289-a719-4cad-bffb-5eaac0928778"> Good Manufacturing Practice and Good Distribution Practice Standards </a> </li> <li class="parent" data-content=""> <a class="state--ignore-tooltip" href="#" data-guid="f3731991-e630-4cde-85f6-a2b5a92caffd"> Certification of local dealers </a> </li> </ul> </div> <div data-label="0baf57d7-e63c-4c85-b702-a326bda7a2c4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Clinical trials </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/overview" data-guid="0531ad74-2289-4cea-a184-7a689f6d8671"> Regulatory overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/apply-cta-ctn" data-guid="2d3c83f8-19ec-4568-9724-287712bced88"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/subsequent-submissions" data-guid="31160422-8263-4e27-bf3d-1defbd279d5d"> Subsequent submissions </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/good-clinical-practice" data-guid="e3acb007-da0a-4179-be0b-34ef4e45a0db"> Good Clinical Practice Inspections </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/adverse-events" data-guid="f58f6596-9749-417f-8bce-58b3cecf0c27"> Report adverse events </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/innovation-office" data-guid="9fb4cc8b-4401-4cf5-99a9-72dec47ed6c1"> Product consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/conducting" data-guid="cbc80f0e-71aa-4edb-8b75-8dbe089eccdd"> Conducting clinical trials </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/clinical-trials-register" data-guid="223ce50c-7b0e-4b00-a1d2-69ec9fb45bad"> Clinical Trials Register </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/clinical-trials/statistics" data-guid="abe53f4d-bee9-45c6-aaaf-a596773a5bd1"> Clinical trials statistics </a> </li> </ul> </div> <div data-label="f9b17351-9e31-4cbe-9368-89990285d3ab" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Licensing and certification of importers and wholesalers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/overview" data-guid="af581c62-35ff-4a88-aa2d-410310050739"> Overview of Importer's and Wholesaler's Licences </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/apply-licence" data-guid="f9204d51-b719-4cfa-b572-091a60a75d78"> Apply for a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/amend-licence" data-guid="c4fdf9a4-20de-40bf-9e9a-1359f42092c5"> Amend a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/renew-or-cancel-licence" data-guid="17fb6e80-e86c-428a-8109-4dcb153d751e"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/gdp-standards" data-guid="e2576b18-4901-4a7a-825d-932ec7a782b8"> Good Distribution Practice Standards </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/importers-and-wholesalers/gdp-certification" data-guid="01c2a80e-143d-450e-a8e0-c14c4c20c76b"> Good Distribution Practice certification </a> </li> </ul> </div> <div data-label="3115698c-9584-4b2a-980e-61f2f1ddce20" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Licensing and certification of manufacturers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/overview" data-guid="d145ce20-5d5c-4bad-8a8e-b9257abbcb24"> Overview of Manufacturer's Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/apply-licence" data-guid="706e3708-bef4-4e46-87e6-360c7e1e79b4"> Apply for a Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/amend-licence" data-guid="3cb8cda8-4999-4003-9679-3875e8f8faeb"> Amend a Licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/renew-or-cancel-licence" data-guid="9d235845-a7a7-4e8e-a7f8-1d7e5819b4b4"> Renew or cancel a licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/gmp-certificate" data-guid="411905ea-c379-472b-b78d-5135499a0340"> Good Manufacturing Practice Certificate </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/inspection-of-manufacturers" data-guid="e98d79ba-d283-4e7e-8d0e-5a74e2150e6f"> Inspection of Manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/active-ingredients/manufacturers/responsibilities" data-guid="719a6af7-8c3c-4024-9dde-565b1774865d"> Responsibilities of Manufacturers </a> </li> </ul> </div> <div data-label="8c5c2c4d-0e40-4323-a87e-b4a3f03a4c2b" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">CTA, CTN or CTC submissions</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/apply-cta-ctn" data-guid="fd5a5cb0-e976-4737-8156-e4d7d89625c0"> New CTA or CTN submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/apply-ctc" data-guid="d881faa6-50b3-4e9a-b49f-c7e836f31927"> New CTC submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/application/subsequent-submissions" data-guid="8606a110-ffa7-48fd-b396-cee1a8c927f3"> Subsequent submissions </a> </li> </ul> </div> <div data-label="525bb14a-8f6c-4ea3-920d-8126125f5443" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Conducting clinical trials</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/principal-investigator" data-guid="09039b0a-e3c4-42c6-a479-256852c976f8"> Principal investigator </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/sponsor" data-guid="96af64b8-f78f-41a7-af9f-ebbeb3745c36"> Sponsor </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/informed-consent" data-guid="c32e93ea-aee8-4d3b-a7fb-7ddd1a03777d"> Informed consent </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/investigational-auxiliary-products" data-guid="d685bdff-7ee3-4fe3-9c5f-5e3da68cab65"> Investigational and auxiliary products </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/investigator-site-file" data-guid="7d157444-ca14-4c71-9e7c-a70d6cfb25f6"> Investigator Site File </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/clinical-trials/conducting/template-forms" data-guid="b86a54e6-d735-4935-9fd8-b5ec9c396afc"> Template forms </a> </li> </ul> </div> <div data-label="2dfb1261-9d74-487f-b59a-8f0c75330def" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Controlled drugs</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/apply" data-guid="09b0b42f-bb0e-4b88-87da-6217c20c9d79"> Apply for a controlled drugs licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/amend" data-guid="80363e35-b7c8-4fdd-89e5-1083b6cf44db"> Amend licence to wholesale or manufacture controlled drugs </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/controlled-drugs-psychotropic-substances/controlled-drugs/renew" data-guid="b24dea71-b089-4f92-9965-b7267a6aeaa9"> Renew or cancel a licence </a> </li> </ul> </div> <div data-label="a42d2730-7835-4ae5-bf0e-f23171a903e5" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Articles</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/consumer-safety/articles/details" data-guid="af2478a5-7fc1-470a-b80f-e1d62b156a71"> Details </a> </li> </ul> </div> <div data-label="adfe758d-5941-4ea6-baf1-69fa38b2a74e" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Articles</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/careers/articles/details" data-guid="48176b72-3c3b-4b1d-9889-363953f7e2da"> Details </a> </li> </ul> </div> </div> <div class="hsa-header__sidebar__extender__column-3"> <div data-label="4ab762eb-155b-466b-8a25-82bd36c8a446" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Grouping medical devices</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/dental-grouping-terms"> Dental Grouping Terms (DGT) </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/hearing-aids"> Hearing aids </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ihc-ivd"> Immunohistochemistry (IHC) IVD reagents </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/fish-probes-ivd"> Fluorescence in situ hybridisation (FISH) probes IVD </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-analysers"> IVD analysers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivf-media"> In vitro fertilisation (IVF) media </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/family"> Family </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/system"> System </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/group"> Group </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/single"> Single </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-test-kit"> IVD Test Kit </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/grouping/ivd-cluster"> IVD cluster </a> </li> </ul> </div> <div data-label="f2dbc2a3-5dd0-48e9-8050-6eefb4934da4" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration guides</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-full-registration"> Class B full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-abridged-registration"> Class B abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-b-immediate-registration"> Class B immediate registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-full-registration"> Class C full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-abridged-registration"> Class C abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-expedited-registration"> Class C expedited registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-c-immediate-registration"> Class C immediate registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-full-registration"> Class D full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-abridged-registration"> Class D abridged registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-expedited-registration"> Class D expedited registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-medicinal-products-full-registration"> Class D with a registrable drug in a secondary role full registration </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/guides/class-d-medicinal-products-abridged-registration"> Class D with registrable drug in secondary role abridged registration </a> </li> </ul> </div> <div data-label="04b8be8f-e147-47dd-89b7-56c00dd52cdc" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/export"> Import for re-export of unregistered devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/non-clinical-purpose"> Unregistered devices for non-clinical purposes </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/consignment-registered"> Registered medical devices on consignment basis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/qualified-practitioner-request"> Unregistered devices requested by qualified practitioners </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/phmc-request"> Unregistered devices requested by licensed healthcare facility </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/custom-made-devices"> Custom-made medical devices </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/import-unregistered-devices-exhibition"> Import of unregistered medical devices for exhibition </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/import-of-unregistered-pre-owned-devices-returned-from-maintenance-repair"> Import of unregistered pre-owned devices from maintenance/repair </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/medical-devices/registration/special-access-routes/PSAR-MD"> PSAR for Supply of Emergency Medical Devices </a> </li> </ul> </div> <div data-label="87e8659d-45a2-40d7-9189-993d38a0633c" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration overview</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/overview"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/application-types"> Application types </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/evaluation-routes"> Evaluation Routes </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/application-dossier"> Application dossier </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/screening-evaluation"> Screening and evaluation stages </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/overview/retain-cancel-transfer"> Retain, cancel or transfer registrations </a> </li> </ul> </div> <div data-label="e10dc8cc-ed64-45f7-b36b-4a3cde564f61" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration guides for therapeutic products</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/new-drug"> New drug application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/generic-drug"> Generic drug application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/biosimilar-products"> Biosimilar product application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/drug-master-file"> Submission of Drug Master File </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/guides/plasma-master-file"> Submission of Plasma Master File </a> </li> </ul> </div> <div data-label="6e925ab4-a2e4-4933-8edc-d51e50dafe86" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes (SAR)</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/import-for-patients"> Import and supply of unregistered TP for patient's use </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/consignment-registered"> Import and supply of registered drug on consignment basis </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/special-consignment-by-a-product-registrant"> Special consignment by a product registrant </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/register/special-access-routes/psar-emergency-therapeutic-product"> Pandemic Special Access Route for Supply of Emergency TP </a> </li> </ul> </div> <div data-label="81f2aeb5-71fc-4437-bcbe-363566451aa3" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Major variation (MAV-1) application</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/overview"> Overview of MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/full-evaluation"> Full evaluation route for MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/abridged-evaluation"> Abridged evaluation route for MAV-1 application </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/mav-1/verification-evaluation"> Verification evaluation route for MAV-1 application </a> </li> </ul> </div> <div data-label="2309de76-0cee-4377-bc01-65f576892d9d" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Minor variation (MIV) application </span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv/overview"> Overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/variation-application/miv/submission"> Submit MIV applications </a> </li> </ul> </div> <div data-label="32be46d4-2acb-4aef-8f28-ebb7fb04cd48" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/certificates/gmp-certificate"> Good Manufacturing Practice certificate for local manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/dealers-licence/certificates/gdp-certificate"> Good Distribution Practice certificate for local dealers </a> </li> </ul> </div> <div data-label="05c2a122-d4f6-4009-9b51-f2586b1974b7" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Nitrosamine impurities in medicines</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/list-of-impacted-medicines"> List of impacted medicines </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/guidance-for-product-registrants"> Guidance for product registrants </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/therapeutic-products/medicines-quality-and-compliance-monitoring/nitrosamine-impurities-in-medicines/test-methods"> Test methods </a> </li> </ul> </div> <div data-label="ebc90580-c276-42ef-981f-bddebc7d94ba" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/chinese-proprietary-medicines/dealers-licence/certification-of-local-manufacturers/gmp-certificate"> Good Manufacturing Practice certificate for local manufacturers </a> </li> </ul> </div> <div data-label="87ce5044-4900-4e2f-9bd0-9cd5157bbbc0" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco retail licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/apply"> Apply for a tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/amend"> Amend tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/renew"> Renew tobacco retail licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/retail/cancel"> Cancel tobacco retail licence </a> </li> </ul> </div> <div data-label="62df10a0-59ba-444c-b39d-95df004b8e57" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Tobacco import and wholesale licence</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/apply"> Apply for tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/amend"> Amend tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/renew"> Renew tobacco import and wholesale licence </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/tobacco-regulation/licences/import-wholesale/cancel"> Cancel tobacco import and wholesale licence </a> </li> </ul> </div> <div data-label="e920cf5a-92be-4b4a-8511-94e6d69e67e6" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Registration overview</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/overview"> Registration overview </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/application"> Application submission </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/pmc"> Pre-market consultation </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/screening-evaluation-rd"> Screening, evaluation and regulatory decision </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/class2/retain-cancel-transfer"> Retain, cancel or transfer registrations </a> </li> </ul> </div> <div data-label="68687f1e-54ec-4c56-97ca-8a69652bc5ca" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Special Access Routes (SAR)</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/sar/unregistered-CTGTP"> Import and supply of unregistered Class 2 CTGTP </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/registration/sar/registered-ctgtp-on-consignment-basis"> Import and supply of CTGTP on consignment basis </a> </li> </ul> </div> <div data-label="f3731991-e630-4cde-85f6-a2b5a92caffd" style="display:none"> <span class="hsa-header__sidebar__controller__group__header">Certification of local dealers</span> <ul> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/certification/gmp-certification"> Good Manufacturing Practice certificate for local manufacturers </a> </li> <li class="link" data-content=""> <a class="state--ignore-tooltip" href="/ctgtp/dealers-licence/certification/gdp-certification"> Good Distribution Practice certificate for local dealers </a> </li> </ul> </div> </div> </div> </aside> <div class="hsa-header__overlay"></div> </header> <nav class="hsa-nav"> <div class="hsa-nav__navbar"> <button class="hsa-nav__menu-btn" type="button" aria-controls="navigation-sidebar" aria-label="sidebar_menu-btn"> <span class="hsa-hamburgers m-r:xs"><span class="hsa-hamburgers__lines"></span> </span> <span class="hsa-nav__menu-btn__text">Browse</span> </button> <div class="hsa-breadcrumbs m:0"> <ol> <li><a href="/">Home </a></li> <li><a href="/medical-devices">Medical devices </a></li> </ol> <div class="hsa-breadcrumbs__crumb-dropdown"> <ul> </ul> </div> </div> <button class="hsa-font-decrease ldsk(d:n)" type="button"><span class="hsa-glyphs--Aminus"></span> <span class="fz:0">Decrease font size</span></button> <button class="hsa-font-increase ldsk(d:n)" type="button"><span class="hsa-glyphs--Aplus"></span> <span class="fz:0">Increase font size</span></button> <button class="hsa-nav__search-btn" type="button" aria-label="search-btn"><span class="hsa-glyphs--search"></span> <span class="hsa-nav__search-btn__text">Search</span></button> <button class="hsa-nav__back-btn" type="button"><span class="hsa-glyphs--chevron-left"></span> <span class="hsa-nav__back-btn__text">Back</span></button> </div> </nav> <main id="content" class="flg:1 bgc:grey-6 z:1" role="main"> <div class="container p-t:4xl p-b:4xl"> <div class="g:12"> <div class="gcol:12 dsk(gcol:8) ord:1"> <div id="main_TB6F372E3007_Col00" class="sf_colsIn" data-sf-element="title" data-placeholder-label="title"> <h1>Guidance documents for medical devices</h1> <p class="hsa-text--summary">Here is the list of guidance documents with relevant forms and templates to help you meet the regulatory requirements for dealing in medical devices.</p> </div> <div id="main_TB6F372E3007_Col01" class="sf_colsIn" data-sf-element="content" data-placeholder-label="content"><div id="main_C004_Col00" class="sf_colsIn hsa-toggle hsa-card p:0" data-sf-element="Toggle" data-placeholder-label="Toggle"><div id="main_C005_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Product Registration</h1> <div> <h2> Product Registration Guidelines</h2> <ul> <li><a title="GN-15-R11 Guidance on Medical Device Product Registration (2024 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-15-r11-guidance-on-medical-device-product-registration-(2024-mar)-pub.pdf?sfvrsn=e6a114ea_4">GN-15-R11 Guidance on Medical Device Product Registration (2024 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>514 KB</span></a><br /> <ul> <li><a title="GN-15-R11 ANNEX 1 Letter of Authorisation Template (2024 Mar)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-15-r11-annex-1-letter-of-authorisation-template-(2024-mar).docx?sfvrsn=4f61fa99_2">GN-15-R11 ANNEX 1 Letter of Authorisation Template (2024 Mar)<em class="hsa-glyphs--doc"></em><span>27 KB</span></a></li> <li><a title="GN-15-R11 ANNEX 2 Marketing History Declaration Template (2024 Mar)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-15-r11-annex-2-marketing-history-declaration-template-(2024-mar).docx?sfvrsn=f3f8adbc_2">GN-15-R11 ANNEX 2 Marketing History Declaration Template (2024 Mar)<em class="hsa-glyphs--doc"></em><span>28 KB</span></a></li> <li><a title="GN-15-R11 ANNEX 3 Safety Declaration Template (2024 Mar)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-15-r11-annex-3-safety-declaration-template-(2024-mar).docx?sfvrsn=2b431247_2">GN-15-R11 ANNEX 3 Safety Declaration Template (2024 Mar)<em class="hsa-glyphs--doc"></em><span>29 KB</span></a></li> </ul> </li> </ul> <h2>Unique Device Identification (UDI) Submission Guidelines</h2> <ul> <li><a title="GN-36-R2 Guidance on Medical Device UDI System (2022 July) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-36-r2-guidance-on-medical-device-udi-system-(2022-july)-pub.pdf?sfvrsn=b2c113ad_2">GN-36-R2 Guidance on Medical Device UDI System (2022 July) PUB<em class="hsa-glyphs--pdf"></em><span>2248 KB</span></a><br /> <ul> <li><a title="FAQ (Medical Device UDI System)_Updated 18 July 2022" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/faq-(medical-device-udi-system)_updated-18-july-2022.pdf?sfvrsn=f8a26f39_2">FAQ (Medical Device UDI System)_Updated 18 July 2022<em class="hsa-glyphs--pdf"></em><span>480 KB</span></a></li> <li><span><a title="UDI-DI Submission video for Registered Medical Devices" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/udi-di-submission-video-for-registered-medical-devices.wmv?sfvrsn=a9b6009_0">UDI-DI Submission video for Registered Medical Devices<span>15398 KB</span></a></span></li> </ul> </li> </ul> <h2>IVD Analysers</h2> <ul> <li><a title="GN-34 R1.3 Guidance Document for IVD Analysers(Feb-pub)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-34-r1-3-guidance-document-for-ivd-analysers(feb-pub).pdf?sfvrsn=384af50b_4">GN-34 R1.3 Guidance Document for IVD Analysers(Feb-pub)<em class="hsa-glyphs--pdf"></em><span>914 KB</span></a> <ul> <li><a title="Annex 2 to GN-34" href="/docs/default-source/medical-devices/annex-2-to-gn-34.xlsx?sfvrsn=cc268d58_2">Annex 2 to GN-34<em></em>18 KB</a></li> </ul> </li> </ul> <h2>Medical Devices Product Classification</h2> <ul> <li><span><a title="GL-06-R2 Medical Devices Product Classification Guide (2023 Oct) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gl-06-r2-medical-devices-product-classification-guide-(2023-oct)-pub.pdf?sfvrsn=aace4397_2">GL-06-R2 Medical Devices Product Classification Guide (2023 Oct) PUB<em class="hsa-glyphs--pdf"></em><span>2076 KB</span></a></span></li> </ul> <h2>Product Specific Regulatory Guidelines</h2> <ul> <li><a title="Regulatory Guidelines for Telehealth Products R2.1" href="/docs/default-source/hprg-mdb/regulatory-guidelines-for-telehealth-products-rev-2-1.pdf?sfvrsn=cc244565_0">Telehealth Products R2.1<em class="hsa-glyphs--pdf"></em><span>1226 KB</span></a> <ul> <li><span><a title="FAQ-Regulatory Guidelines for Telehealth Products R2.0" href="/docs/default-source/hprg-mdb/faq-regulatory-guidelines-for-telehealth-products-rev-2-0.pdf?sfvrsn=d573bd3_0">FAQ Telehealth Products R2.0<em class="hsa-glyphs--pdf"></em><span>401 KB</span></a></span></li> </ul> </li> <li><span><a title="Aesthetic-Related Guidelines_2018" href="/docs/default-source/hprg-mdb/aesthetic-related-guidelines_2018.pdf?sfvrsn=d59147ae_0">Aesthetic-Related Guidelines_2018<em class="hsa-glyphs--pdf"></em><span>461 KB</span></a></span></li> <li><span><a title="NGS (IVDs)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/ngs-ivds-requirements-(19dec-pub).pdf?sfvrsn=b98fb147_0">NGS (IVDs)<em class="hsa-glyphs--pdf"></em><span>588 KB</span></a></span></li> <li><a title="GL-04-R3 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2024 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gl-04-r3-regulatory-guidelines-for-software-medical-devices---a-life-cycle-approach-(2024-mar)-pub.pdf?sfvrsn=bbb0bdd2_4">GL-04-R3 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2024 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>985 KB</span></a></li> <li><a title="Guidelines-Risk-Classification-SAMD-CDSS (2022 Apr) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/guidelines-risk-classification-samd-cdss-(2022-apr)-pub68164581f0d548c29794b7c61b3c8dfc.pdf?sfvrsn=2fc30dbf_2">Guidelines-Risk-Classification-SAMD-CDSS (2022 Apr) PUB<em class="hsa-glyphs--pdf"></em><span>410 KB</span></a></li> <li><span><a title="REGULATORY GUIDELINE FOR 3D-PRINTED MEDICAL DEVICES" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/regulatory-guideline-for-3d-printed-medical-devices.pdf?sfvrsn=72ed49f7_0">Regulatory Guideline For 3D-Printed Medical Devices<em class="hsa-glyphs--pdf"></em><span>601 KB</span></a></span> <ul> <li><span><a title="FAQ (3DP Medical Devices) 2021" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/faq-(3dp-medical-devices)-2021.pdf?sfvrsn=970b8e7d_0">FAQ (3DP Medical Devices) 2021<em class="hsa-glyphs--pdf"></em><span>804 KB</span></a></span></li> </ul> </li> </ul> <ul> <li><a title="GL-08-R1 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2023 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gl-08-r1-regulatory-guidelines-for-laboratory-developed-tests-(ldts)-(2023-mar)-pub.pdf?sfvrsn=4a20fcfa_2">GL-08-R1 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2023 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>293 KB</span></a><br /> <ul> <li><a title="Annex 1. LDT Objective checklist Template" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-1-ldt-objective-checklist-template.docx?sfvrsn=81bd1f84_2">Annex 1. LDT Objective checklist Template<em class="hsa-glyphs--doc"></em><span>18 KB</span></a></li> </ul> </li> </ul> <h2>Product Registration Dossier Requirements </h2> <ul> <li><a title="GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-17-r3-guidance-on-preparation-of-a-product-registration-submission-for-gmd-using-the-asean-csdt-(2024-mar)-pub.pdf?sfvrsn=f213dafe_8">GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>1806 KB</span></a><br /> <ul> <li><a title="E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R3 (2024 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/e-submission-guide-for-general-medical-devices-for-asean-csdt-and-imdrf-toc-based-submissions-in-medics-r3-(2024-mar)-pub.pdf?sfvrsn=ca0aa6ee_2">E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R3 (2024 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>393 KB</span></a></li> <li><a title="Annex 2 for GN-17 and GN18 List of Configurations (2024 Mar)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-2-for-gn-17-and-gn18-list-of-configurations-(2024-mar).xlsx?sfvrsn=2f59badc_2">Annex 2 for GN-17 and GN18 List of Configurations (2024 Mar)<em class="hsa-glyphs--xls"></em><span>49 KB</span></a></li> </ul> </li> <li><a title="GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-18-r3-guidance-on-preparation-of-a-product-registration-submission-for-ivd-md-using-the-asean-csdt-(2024-mar)-pub.pdf?sfvrsn=1eac010b_4">GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>1491 KB</span></a><br /> <ul> <li><a title="E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R3 (2024 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/e-submission-guide-for-ivd-md-for-asean-csdt-and-imdrf-toc-based-submissions-in-medics-r3-(2024-mar)-pub.pdf?sfvrsn=c9f695c_2">E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R3 (2024 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>404 KB</span></a></li> <li><a title="Annex 2 for GN-17 and GN18 List of Configurations (2024 Mar)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-2-for-gn-17-and-gn18-list-of-configurations-(2024-mar).xlsx?sfvrsn=2f59badc_2">Annex 2 for GN-17 and GN18 List of Configurations (2024 Mar)<em class="hsa-glyphs--xls"></em><span>49 KB</span></a></li> </ul> </li> </ul> <h2> Medical Devices Risk Classification </h2> <ul> <li><span><a title="GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices (18Sep-pub)" href="/docs/default-source/medical-devices/gn-13-r2-1-guidance-on-the-risk-classification-of-general-medical-devices-(18sep-pub).pdf?sfvrsn=32a1e2ab_2">GN-13-R2.1 Guidance on the Risk Classification of General Medical Devices (18Sep-pub)<em class="hsa-glyphs--pdf"></em><span>755 KB</span></a></span></li> <li><a title="GN-14-R2 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (updated on 1 June 2018)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-14-r3-guidance-on-the-risk-classification-of-in-vitro-diagnostic-md-(2023-jul)-pub.pdf?sfvrsn=58f33d7a_2">GN-14-R3 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices (updated on 24 July 2023)<em class="hsa-glyphs--pdf"></em><span>320 KB</span></a></li> </ul> <p> </p> <h2> Grouping of Medical Devices </h2> <p> </p> <ul> <li><a title="GN-12-1-R2.1 Guidance on Grouping of Medical Devices for Product Registration - General Grouping Criteria (Updated on November 2017)" href="/docs/default-source/medical-devices/gn-12-1-r2-1-guidance-on-grouping-of-medical-devices-for-product-registration---general-grouping-criteria(17nov-pub).pdf?sfvrsn=e13aec9a_2">GN-12-1-R2.1 Guidance on Grouping of Medical Devices for Product Registration - General Grouping Criteria (Updated on November 2017)<em class="hsa-glyphs--pdf"></em><span>616 KB</span></a></li> <li><a title="GN-12-2-R2 Guidance on Grouping-Specific (2022 Jan) PUB" href="/docs/default-source/hprg-mdb/gn-12-2-r2-guidance-on-grouping-specific-(2022-jan)-pub.pdf?sfvrsn=36191660_2">GN-12-2-R2 Guidance on Grouping-Specific (2022 Jan) PUB<em class="hsa-glyphs--pdf"></em><span>446 KB</span></a></li> </ul> <h2> Labelling of Medical Devices</h2> <ul> <li><a title="GN-23-R2 Guidance on Labelling for Medical Devices(2022 Sep) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-23-r2-guidance-on-labelling-for-medical-devices(2022-sep)-pub.pdf?sfvrsn=5bf1b0b9_2">GN-23-R2 Guidance on Labelling for Medical Devices(2022 Sep) PUB<em class="hsa-glyphs--pdf"></em><span>292 KB</span></a></li> </ul> <h2> Clinical Evaluation</h2> <ul> <li><a title="GN-20-R2 Guidance on Clinical Evaluation(2022 Nov)_PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-20-r2-guidance-on-clinical-evaluation(2022-nov)_pub.pdf?sfvrsn=426a4e43_2">GN-20-R2 Guidance on Clinical Evaluation(2022 Nov)_PUB<em class="hsa-glyphs--pdf"></em><span>443 KB</span></a></li> </ul> <h2> Declaration of Conformity</h2> <ul> <li><a title="GN-11-R1.3_Guidance on the Declaration of Conformity(2022 Nov)_PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-11-r1-3_guidance-on-the-declaration-of-conformity(2022-nov)_pub.pdf?sfvrsn=aed03497_2">GN-11-R1.3_Guidance on the Declaration of Conformity(2022 Nov)_PUB<em class="hsa-glyphs--pdf"></em><span>266 KB</span></a><br /> <ul> <li><a title="GN-11 Declaration of Conformity Template(2022 Nov)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-11-declaration-of-conformity-template(2022-nov).doc?sfvrsn=64b21a3e_2">GN-11 Declaration of Conformity Template(2022 Nov)<em class="hsa-glyphs--doc"></em><span>32 KB</span></a></li> </ul> </li> </ul> <h2> Essential Principles for Safety and Performance</h2> <ul> <li><a title="GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-16-r4-guidance-on-essential-principles-for-safety-and-performance-of-medical-devices(2023-sep)-pub.pdf?sfvrsn=88fbb855_2">GN-16-R4 Guidance on Essential Principles for Safety and Performance of Medical Devices(2023 Sep) PUB<em class="hsa-glyphs--pdf"></em><span>331 KB</span></a><br /> <ul> <li><span><a title="Annex 2 GN-16 R4 Essential Principles Checklist Template (June 2018 version)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-2-gn-16-r4-essential-principles-checklist-template-(june-2018-version).doc?sfvrsn=ef91caca_2">Annex 2 GN-16 R4 Essential Principles Checklist Template (June 2018 version)<em class="hsa-glyphs--doc"></em><span>172 KB</span></a></span></li> <li><span><a title="Annex 3 GN-16 R4 Essential Principles Checklist Template (Dec 2017 version)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-3-gn-16-r4-essential-principles-checklist-template-(dec-2017-version).doc?sfvrsn=f0eb97e8_2">Annex 3 GN-16 R4 Essential Principles Checklist Template (Dec 2017 version)<em class="hsa-glyphs--doc"></em><span>128 KB</span></a></span></li> </ul> </li> </ul> </div></div> </div> </div><div id="main_C006_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Dealer's licensing</h1> <h2> Manufacturers, Importers and Wholesalers Licensing</h2> <ul> <li><a title="GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-02-r5-guidance-on-licensing-of-manufacturers-importers-and-wholesalers-of-md-(2023-jul)-pub.pdf?sfvrsn=e2d39d54_2">GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB<em class="hsa-glyphs--pdf"></em><span>403 KB</span></a><br /> <ul> <li><span><a title="GN-02-R5 Annex 1 Declaration for Exemption from GDPMDS (2023 Jul)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-02-r5-annex-1-declaration-for-exemption-from-gdpmds-(2023-jul).docx?sfvrsn=ff6e81c_2">GN-02-R5 Annex 1 Declaration for Exemption from GDPMDS (2023 Jul)<em class="hsa-glyphs--doc"></em><span>39 KB</span></a></span></li> <li><span><a title="GN-02-R5 Annex 5 Declaration of Conformity to a QMS (2023 Jul)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-02-r5-annex-5-declaration-of-conformity-to-a-qms-(2023-jul).docx?sfvrsn=66bcb64d_2">GN-02-R5 Annex 5 Declaration of Conformity to a QMS (2023 Jul)<em class="hsa-glyphs--doc"></em><span>39 KB</span></a></span></li> <li><span><a title="GN-02-R5 Annex 6 Declaration of Non-Dealing of Class A Medical Devices (2023 Jul)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-02-r5-annex-6-declaration-of-non-dealing-of-class-a-medical-devices-(2023-jul).docx?sfvrsn=964b06d0_2">GN-02-R5 Annex 6 Declaration of Non-Dealing of Class A Medical Devices (2023 Jul)<em class="hsa-glyphs--doc"></em><span>33 KB</span></a></span></li> </ul> </li> </ul> <h2> Documents for Licensing</h2> <ul> <li><a title="GN-03-R3 Guidance on Preparation of a Site Master File for Licensing" href="/docs/default-source/hprg-mdb/gn-03-r3-guidance-on-preparation-of-a-site-master-file-for-licensing.pdf?sfvrsn=eab2ead3_0">GN-03-R3 Guidance on Preparation of a Site Master File for Licensing<em class="hsa-glyphs--pdf"></em><span>71 KB</span></a><br /> <ul> <li><a title="SMF Example for GN-03 Guidance on Preparation of a Site Master File for Licensing" href="/docs/default-source/medical-devices/smf-example-for-gn-03-guidance-on-preparation-of-a-site-master-file-for-licensing.pdf?sfvrsn=2e3398fd_2">SMF Example for GN-03 Guidance on Preparation of a Site Master File for Licensing<em class="hsa-glyphs--pdf"></em><span>84 KB</span></a></li> </ul> </li> </ul> <h2> Class A Medical Devices</h2> <ul> <li><span><a title="GN-22 R7.4 Guidance for Dealers on Class A Medical Devices (22 Mar-pub)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-22-r7-4-guidance-for-dealers-on-class-a-medical-devices-(22-mar-pub).pdf?sfvrsn=519972fc_0">GN-22 R7.4 Guidance for Dealers on Class A Medical Devices (22 Mar-pub)<em class="hsa-glyphs--pdf"></em><span>336 KB</span></a><br /> </span></li> </ul> <h2> Good Distribution Practice for Medical Devices (GDPMDS) </h2> <ul> <li><a title="GN-33 R2 Guidance on the Application of Singapore Standard GDPMDS (2023 Sep) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-33-r2-guidance-on-the-application-of-singapore-standard-gdpmds-(2023-sep)-pub.pdf?sfvrsn=d6a33416_2">GN-33 R2 Guidance on the Application of Singapore Standard GDPMDS (2023 Sep) PUB<em class="hsa-glyphs--pdf"></em><span>464 KB</span></a></li> <li><a title="GN-06-R3 Guidance on Distribution Records(2022 Nov)_PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-06-r3-guidance-on-distribution-records(2022-nov)_pub.pdf?sfvrsn=91dd0415_2">GN-06-R3 Guidance on Distribution Records(2022 Nov)_PUB<em class="hsa-glyphs--pdf"></em><span>245 KB</span></a></li> </ul></div> </div> </div><div id="main_C010_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Change Notification and Amendments</h1> <h2> Change of Registered Medical Device</h2> <ul> <li><a title="GN-21-R5 Guidance on Change Notification for Registered MD (2023 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-21-r5-guidance-on-change-notification-for-registered-md-(2023-mar)-pub.pdf?sfvrsn=fd98324_2">GN-21-R5 Guidance on Change Notification for Registered MD (2023 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>888 KB</span></a><br /> <ul> <li><a title="Annex 2 to GN-21 R4.7 Guidance on Change Notification for Registered MD(Feb)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-2-to-gn-21-r4-7-guidance-on-change-notification-for-registered-md(feb).doc?sfvrsn=dd479b8a_2">Annex 2 to GN-21 R4.7 Guidance on Change Notification for Registered MD(Feb)<em class="hsa-glyphs--doc"></em><span>46 KB</span></a></li> </ul> </li> </ul> <ul> <li><a title="Change Notification applications arising from the EU MDR/IVDR related changes to registered medical devices" href="/docs/default-source/hprg-mdb/change-notifications-arising-from-the-eu-mdrivdr-related-changes-(2023-nov)-pub.pdf?sfvrsn=edba221_2">Change Notification applications arising from the EU MDR/IVDR related changes to registered medical devices<em class="hsa-glyphs--pdf"></em><span>419 KB</span></a><br /> <ul> <li><a title="Annex 1 to Change Notification applications arising from the EU MDR/IVDR related changes to registered medical devices" href="/docs/default-source/hprg-mdb/annex-1-to-cn-arising-from-the-eu-mdrivdr-related-changes-(2023-nov)-pub.docx?sfvrsn=a418f748_2">Annex 1 to Change Notification applications arising from the EU MDR/IVDR related changes to registered medical devices<em class="hsa-glyphs--doc"></em><span>30 KB</span></a></li> </ul> </li> </ul> <h2>Change of Registrant</h2> <ul> <li><a title="GN-24-R1.4 Guidance on the Change of Registrant (22 Mar-pub)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-24-r1-4-guidance-on-the-change-of-registrant-(22-mar-pub).pdf?sfvrsn=682a733c_0">GN-24-R1.4 Guidance on the Change of Registrant (22 Mar-pub)<em class="hsa-glyphs--pdf"></em><span>300 KB</span></a><br /> <ul> <li><a title="ANNEX 1 GN-24-R1.4 Guidance on the Change of Registrant (22Mar)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-1-gn-24-r1-4-guidance-on-the-change-of-registrant-(22mar).docx?sfvrsn=2a1c160_0">ANNEX 1 GN-24-R1.4 Guidance on the Change of Registrant (22Mar)<em class="hsa-glyphs--doc"></em><span>26 KB</span></a></li> <li><a title="ANNEX 2 GN-24-R1.4 Guidance on the Change of Registrant (22Mar)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/annex-2-gn-24-r1-4-guidance-on-the-change-of-registrant-(22mar).docx?sfvrsn=5b7bfa23_0">ANNEX 2 GN-24-R1.4 Guidance on the Change of Registrant (22Mar)<em class="hsa-glyphs--doc"></em><span>173 KB</span></a></li> </ul> </li> </ul> <h2> Cancellation of Medical Device </h2> <ul> <li><a title="GN-25-R1 Guidance on the Cancellation of Medical Device Listing" href="/docs/default-source/medical-devices/gn-25-r1_guidance-on-the-cancellation-of-medical-device-listing(17dec-pub).pdf?sfvrsn=8ac8df7_2">GN-25-R1 Guidance on the Cancellation of Medical Device Listing<em class="hsa-glyphs--pdf"></em><span>327 KB</span></a></li> </ul></div> </div> </div><div id="main_C008_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Special Access Routes</h1> <ul> <li><a title="GN-35-R4 Guidance on Special Access Routes (2023 Jan) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-35-r4-guidance-on-special-access-routes-(2023-jan)-pub.pdf?sfvrsn=a9ad0cba_2">GN-35-R4 Guidance on Special Access Routes (2023 Jan) PUB<em class="hsa-glyphs--pdf"></em><span>3288 KB</span></a><br /> <ul> <li><a title="SAR Device List" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/sar_device_list_protected.xls?sfvrsn=81b2249c_2">SAR Device List<em class="hsa-glyphs--xls"></em><span>54 KB</span></a></li> <li><a title="Request form for unregistered medical device for use on patients by QP and Licensed HCF(2022 Aug)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/request-form-for-unregistered-medical-device-for-use-on-patients-by-qp-and-licensed-hcf(2022-aug).pdf?sfvrsn=38832535_2">Request form for unregistered medical device for use on patients by QP and Licensed HCF(2022 Aug)<em class="hsa-glyphs--pdf"></em><span>1934 KB</span></a> by qualified practitioner and healthcare facility (for GN-26 and GN-27 application)</li> <li><a title="MOH Clinical Justification Review Form For Unregistered Class D Medical Device" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/moh-clinical-justification-review-form-for-unregistered-class-d-medical-device.docx?sfvrsn=c148149c_2">MOH Clinical Justification Review Form For Unregistered Class D Medical Device<em class="hsa-glyphs--doc"></em><span>30 KB</span></a></li> <li><a href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-30-product-owner-authorisation-template-(18mar-pub).doc?sfvrsn=12e98fcd_2" title="Attestation" target="_blank">Attestation<em class="hsa-glyphs--doc"></em><span>36 KB</span></a> from product owner (for GN-30 application)</li> </ul> </li> <li><a href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/sar-webinar-slides_24mar22--(31-mar-pub).pdf?sfvrsn=a4dbad6e_2" title="SAR webinar slides_24mar22">SAR webinar slides_24mar22<em class="hsa-glyphs--pdf"></em><span>616 KB</span></a></li> </ul> <h2> Import of Unregistered Medical Devices for Exhibition</h2> <ul> <li><a href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-32-r5-guidance-for-importation-of-unregistered-md-for-exhibition-(2022-sep)-pub.pdf?sfvrsn=8bcdde3c_2" title="GN-32-R5 Guidance for Importation of Unregistered MD for Exhibition (2022 Sep) PUB">GN-32-R5 Guidance for Importation of Unregistered MD for Exhibition (2022 Sep) PUB<em class="hsa-glyphs--pdf"></em><span>291 KB</span></a>    </li> </ul> <h2> Custom-made Medical Devices </h2> <ul> <li><a href="/docs/default-source/medical-devices/list-of-custom-made-medical-devices_august-2014.xlsx?sfvrsn=546dc5de_2" title="List of Custom-made Medical Devices_August 2014">List of Custom-made Medical Devices_August 2014<em class="hsa-glyphs--xls"></em><span>12 KB</span></a></li> </ul></div> </div> </div><div id="main_C012_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Advertisement and Sales Promotion</h1><ul><li><span><a title="GN-08-R2 Guidance on Medical Device Advertisements and Sales Promotion" href="/docs/default-source/hprg-mdb/gn-08-r2-guidance-on-medical-device-advertisements-and-sales-promotion.pdf?sfvrsn=c06fad25_0">GN-08-R2 Guidance on Medical Device Advertisements and Sales Promotion<em class="hsa-glyphs--pdf"></em><span>215 KB</span></a></span></li><li><a target="_blank" href="/docs/default-source/hprg-vcb/medical-advertisements-sales-promotion/guidance_hcsa_tm_7nov2024.pdf?sfvrsn=1ab89dbe_1">Guidance for HCSA Licensees and Telemedicine Service Providers on Advertisement Controls of Health Products</a><ul><li><a target="_blank" href="/docs/default-source/hprg-vcb/medical-advertisements-sales-promotion/faqs-on-guidance-for-hcsa-licensees-and-telemed-service-providers-on-advertisement-controls-of-health-products-7nov2024.pdf?sfvrsn=dbabac9a_1">FAQs on Guidance for HCSA Licensees and Telemedicine Service Providers on Advertisement Controls of Health Products</a></li></ul></li></ul></div> </div> </div><div id="main_C014_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Safety Monitoring</h1> <div> <h2> Adverse Events Reporting </h2> <ul> <li><a title="GN-05-R3 Guidance on the Reporting of Adverse Events (2023 Sep) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-05-r3-guidance-on-the-reporting-of-adverse-events-(2023-sep)-pub.pdf?sfvrsn=d92e94b3_2">GN-05-R3 Guidance on the Reporting of Adverse Events (2023 Sep) PUB<em class="hsa-glyphs--pdf"></em><span>274 KB</span></a> </li> </ul> <h2> Field Safety Corrective Action (FSCA) </h2> <ul> <li><a title="GN-10-R3.1 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2019)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-10-r3-6-guidance-on-medical-device-field-safety-corrective-action(20jan-pub).pdf?sfvrsn=fca4655a_2">GN-10-R3.6 Guidance on Medical Device Field Safety Corrective Action (Updated on January 2020)<em class="hsa-glyphs--pdf"></em><span>666 KB</span></a> <ul> <li><a title="GN-10 Annex 1 Declaration on Completion of Correction Template (Updated on August 2018)" href="/docs/default-source/medical-devices/gn-10-annex-1(18aug).doc?sfvrsn=b1ef3467_2">GN-10 Annex 1 Declaration on Completion of Correction Template (Updated on August 2018)<em class="hsa-glyphs--doc"></em><span>97 KB</span></a></li> </ul> </li> </ul> <h2> Recall of Medical Devices </h2> <ul> <li><a title="GN-04-R2.2 Guidance on Medical Device Recall" href="/docs/default-source/medical-devices/gn-04-r2-2_guidance-on-medical-device-recall(17nov-pub).pdf?sfvrsn=efdebcee_2">GN-04-R2.2 Guidance on Medical Device Recall<em class="hsa-glyphs--pdf"></em><span>339 KB</span></a></li> </ul> <h2> Complaint Handling </h2> <ul> <li><a title="GN-07-R3 Guidance on Complaint Handling (2023 Sep) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-07-r3-guidance-on-complaint-handling-(2023-sep)-pub.pdf?sfvrsn=cb435421_2">GN-07-R3 Guidance on Complaint Handling (2023 Sep) PUB<em class="hsa-glyphs--pdf"></em><span>237 KB</span></a></li> </ul> <h2> Dear Healthcare Professional Letter (DHCPL)</h2> <ul> <li><a title="GN-09-R3.6 Guidance on the Component Elements of a DHCPL (2022 May) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-09-r3-6-guidance-on-the-component-elements-of-a-dhcpl-(2022-may)-pub.pdf?sfvrsn=2782f992_2">GN-09-R3.6 Guidance on the Component Elements of a DHCPL (2022 May) PUB<em class="hsa-glyphs--pdf"></em><span>292 KB</span></a><br /> <ul> <li><a title="GN-09 R3.6 Annex 1 (2022 May)" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gn-09-r3-6-annex-1-(2022-may).docx?sfvrsn=7ca800f2_2">GN-09 R3.6 Annex 1 (2022 May)<em class="hsa-glyphs--doc"></em><span>32 KB</span></a></li> </ul> </li> </ul> </div></div> </div> </div><div id="main_C016_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Technical Reference Documents</h1> <ul> <li><a title="TR-01 R3 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/tr-01-r3-contents-of-a-product-registration-submission-for-gmd-using-the-asean-csdt-(2024-mar)-pub.pdf?sfvrsn=c9fb71db_2">TR-01 R3 Contents of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>340 KB</span></a></li> <li><a title="TR-02 R3 Contents of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB" href="/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/tr-02-r3-contents-of-a-product-registration-submission-for-ivd-md-using-the-asean-csdt-(2024-mar)-pub.pdf?sfvrsn=471b52a4_2">TR-02 R3 Contents of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB<em class="hsa-glyphs--pdf"></em><span>382 KB</span></a></li> </ul></div> </div> </div><div id="main_C018_Col00" class="sf_colsIn togglepanel" data-sf-element="Toggle Panel" data-placeholder-label="Toggle Panel"> <div > <div ><h1>Archived Regulatory Guidances</h1> <ul> <li><a href="/medical-devices/guidance-documents/archived-regulatory-guidances">Archived Regulatory Guidances</a></li> </ul></div> </div> </div> </div></div> </div> </div> <div class="g:12"> <div class="gcol:12 dsk(gcol:8)"> <div class="p-t:2xl m-b:2xl"> <div id="main_TB6F372E3007_Col02" class="sf_colsIn" data-sf-element="date updated" data-placeholder-label="date updated"> <time class="hsa-text--small m:0 p:0" datetime="2018-10-31" id="pageUpdatedTime">Last updated: <span id="pageUpdated">31 Dec 2018</span></time> <script> var pageTitle = document.title; $(document).ready(function () { $.getJSON('/GetPageModified/' + pageTitle, function (x) { var timeElement = document.getElementById("pageUpdatedTime"); if (timeElement) { timeElement.setAttribute("datetime", x.DateTime); document.getElementById("pageUpdated").textContent = x.DateTimeStr; } }); }); </script></div> <div id="main_TB6F372E3007_Col03" class="sf_colsIn hsa-share" 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