{"id":4347,"date":"2021-10-08T11:20:00","date_gmt":"2021-10-08T11:20:00","guid":{"rendered":"https:\/\/www.vistaar.ai\/?p=4347"},"modified":"2025-12-03T03:34:49","modified_gmt":"2025-12-03T03:34:49","slug":"registration-of-drug-device-combination-products","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/registration-of-drug-device-combination-products\/","title":{"rendered":"Registration of Drug-device Combination Products"},"content":{"rendered":"\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-df655d2390608302adfa72ff952190ae\">NMPA Notice on the Registration Requirements for Drug\u2013Device Combination Products<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">To strengthen the regulatory oversight and registration management of drug\u2013device combination products, and in accordance with applicable drug and medical device registration regulations, the following requirements were issued on July 23:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>I. Definition &#8211;\u00a0<\/strong>Drug\u2013device combination products are medical products composed of both a drug component and a medical device component, produced and supplied as a single integrated product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>II. Registration Pathway &#8211;\u00a0<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Drug\u2011led combination products must be registered in accordance with drug registration requirements.\u00a0<\/li>\n\n\n\n<li>Device\u2011led combination products must be registered following medical device requirements.\u00a0<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">If the drug or device component has already been approved for marketing in China or in the country\/region of origin, the corresponding marketing authorization document must be included in the registration submission. Requirements for application dossiers are detailed in relevant regulatory documents and guidance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>III. Attribute Determination &#8211;\u00a0<\/strong>Applicants must fully assess the characteristics of the combination product they intend to register.\u00a0If the primary mode of action\u2014or attribute\u2014of the product cannot be clearly determined, applicants must submit an attribute determination request to the Center for Medical Device Standards Management (CMDSM) of NMPA before filing the registration application.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>IV. Review of Attribute Determination &#8211;\u00a0<\/strong>CMDSM will review the submitted dossiers for accepted attribute determination requests and provide a formal determination based on established procedures.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Applicants will be informed of the outcome through the Information System for Attribute Definition of Drug\u2013Device Combination Products, and results will be published on the official website.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>V. Registration Submission &#8211;\u00a0<\/strong>Applicants must submit the drug or device registration application to NMPA according to the determined attribute of the product.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The application form must explicitly indicate that the product is a \u201cdrug\u2013device combination product.\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>VI. Evaluation Mechanism &#8211;\u00a0<\/strong>The Center for Drug Evaluation (CDE) and the Center for Medical Device Evaluation (CMDE) have established a coordination mechanism:\u00a0<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>For drug\u2011led products: CDE leads the evaluation. If joint review is needed, the dossier will be forwarded to CMDE for parallel evaluation.\u00a0<\/li>\n\n\n\n<li>For device\u2011led products: CMDE leads the review. If joint evaluation is required, the dossier will be forwarded to CDE.\u00a0<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">For products undergoing joint evaluation, CDE and CMDE will collaborate on communication and technical discussions. Each center will issue its own evaluation report addressing the safety, effectiveness, and quality controllability of its respective component. The lead center will integrate these assessments, prepare the overall evaluation conclusion, and submit it to the appropriate NMPA department for administrative approval.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>VII. Existing Provisions &#8211;\u00a0<\/strong>If relevant regulations or documents already specify the management attributes of certain combination products, those provisions take precedence.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>VIII. Implementation &#8211;\u00a0<\/strong>This Notice takes effect on the date of issuance.\u00a0<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>The following documents are simultaneously repealed:\u00a0<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u201cNotice on Matters Concerning the Registration of Drug\u2013Device Combination Products\u201d (Former CFDA Notice [2009] No. 16)\u00a0<\/li>\n\n\n\n<li>\u201cNotice on Matters Concerning the Adjustment of Attribute Definition of Drug\u2013Device Combination Products\u201d (NMPA Notice [2019] No. 28)\u00a0<\/li>\n<\/ul>\n\n\n<div style=\"color:#00bab9;font-size:16px\" class=\"taxonomy-post_tag has-link-color wp-elements-927c70617f5f183ae903ddc7892f010b wp-block-post-terms has-text-color\"><span class=\"wp-block-post-terms__prefix\"><mark style=\"background-color:#ffffff\" class=\"has-inline-color has-black-color\"><strong>Tags:<\/strong> <\/mark><\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/combinationproduct\/\" rel=\"tag\">combinationproduct<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/drug\/\" rel=\"tag\">drug<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medicaldevice\/\" rel=\"tag\">medicaldevice<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/nmpa\/\" rel=\"tag\">NMPA<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/registrationofdrug\/\" rel=\"tag\">registrationofdrug<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/registrationondevice\/\" rel=\"tag\">registrationondevice<\/a><\/div>\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>NMPA Notice on the Registration Requirements for Drug\u2013Device Combination Products To strengthen the regulatory oversight and registration management of drug\u2013device combination products, and in accordance with applicable drug and medical device registration regulations, the following requirements were issued on July 23: I. Definition &#8211;\u00a0Drug\u2013device combination products are medical products composed of both a drug component [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1885,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[647],"tags":[428,429,430,163,431,432],"class_list":["post-4347","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-standards","tag-combinationproduct","tag-drug","tag-medicaldevice","tag-nmpa","tag-registrationofdrug","tag-registrationondevice"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>Registration of Drug-device Combination Products<\/title>\r\n<meta name=\"description\" content=\"Drug-device combination products refer to medical products composed of drugs and medical devices and produced as a single entity.\" \/>\r\n<meta 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