{"id":1945,"date":"2020-01-22T11:57:00","date_gmt":"2020-01-22T11:57:00","guid":{"rendered":"http:\/\/localhost\/vistaar.ai\/?p=1945"},"modified":"2024-07-01T05:53:27","modified_gmt":"2024-07-01T05:53:27","slug":"chinas-cmde-announces-new-regulations-on-the-supervision-and-administration-of-customized-medical-devices-for-clinical-trials","status":"publish","type":"post","link":"https:\/\/stage-websites.ddismart.com\/vistaar\/blog\/chinas-cmde-announces-new-regulations-on-the-supervision-and-administration-of-customized-medical-devices-for-clinical-trials\/","title":{"rendered":"China\u2019s CMDE Announces New Regulations on the Supervision and Administration of Customized Medical Devices for Clinical Trials"},"content":{"rendered":"\n<p class=\"has-black-color has-text-color has-link-color wp-elements-3fe338e7b1fde846cfd034f84e0fea51 wp-block-paragraph\">The Center of Medical Device Evolution (CMDE) of China has released a regulation (notification 53) that clarifies the requirements for the definition, listing, design, processing, usage, supervision and management of Customized medical devices.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-bbc3ed783a6f17f9fda7458899bd214a wp-block-paragraph\"><strong>Definition of Customized Medical Devices:<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-d5f774a3d9f51f7b324e7c5d9cdf0692 wp-block-paragraph\">According to the article 31 of the notification 53 stated that personalized medical devices can be divided into:<\/p>\n\n\n\n<ol>\n<li style=\"color:#000;\">Customized medical devices (CMD) are devices that are designed and produced according to suitable provisions based upon the clinical needs of a specific patient group as determined by the physician. These devices are specifically catered for rare conditions. Personalized medical devices are expected to improve the diagnostic performance and treatment efficacy.<\/li>\n<li style=\"color:#000;\">Patient matching medical device (PMMD), are devices designed and produced for a particular patient by a medical device manufacturer through a proven process based on standard provisions for mass production of medical devices, in accordance with the clinical demands.<\/li>\n<\/ol>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-ea3ebe5c9c16328ecee47109ea74631e wp-block-paragraph\">The medical device manufacturers and the medical institutions can together act as license holders of customized devices. The regulation has set clear requirements in order to properly mitigate risks associated with the use of such devices.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-479c0ceb99f7cc0f0d8bb827c2bcbfba wp-block-paragraph\"><strong>Regulatory Requirements for Submission of Customized Medical Devices:<\/strong><\/p>\n\n\n\n<ul class=\"has-black-color has-text-color has-link-color wp-block-list wp-elements-d3ea814705ffc1918b8b29ad961297ea\">\n<li>Customized device application form<\/li>\n\n\n\n<li>Declaration for necessity of production and use of customized device<\/li>\n\n\n\n<li>Relevant product research materials<\/li>\n\n\n\n<li>Product risk analysis data<\/li>\n\n\n\n<li>Manufacturing information<\/li>\n\n\n\n<li>Clinical application plan<\/li>\n\n\n\n<li>Opinion of Ethics committee<\/li>\n\n\n\n<li>Agreement between Contract of manufacturer with medical institution<\/li>\n\n\n\n<li>Administrative information<\/li>\n\n\n\n<li>Declaration of conformity<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-404329a3cc8c3244a926df924feae971 wp-block-paragraph\"><strong>The Regulation shall also mention the following points:<\/strong><\/p>\n\n\n\n<ul class=\"has-black-color has-text-color has-link-color wp-block-list wp-elements-7624f5cac462572b2c6797408b4f3c7b\">\n<li>3D printing device would be validated and controlled in various aspects: production and verification processes, manufacturing process, post-treatment, testing of raw materials and final products, as well as cleaning, packaging and sterilization.<\/li>\n\n\n\n<li>The qualification of medical institution for conducting surgery must be approved by NMPA.<\/li>\n\n\n\n<li>Before using device, clinician, patient, and manufacturer need to sign three-party contract.<\/li>\n\n\n\n<li>Non-replaceable device which qualified subjects are rare, cohort research with 10-20 subjects could be conducted, with a comprehensive analysis with historical data.<\/li>\n<\/ul>\n\n\n<div style=\"color:#00bab9\" class=\"taxonomy-post_tag has-link-color wp-elements-94369c2a0fb910f7965f05f6e9c7b761 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\">Tags:<\/mark> <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/china\/\" rel=\"tag\">China<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/medical-device\/\" rel=\"tag\">Medical Device<\/a><span class=\"wp-block-post-terms__separator\">, <\/span><a href=\"https:\/\/stage-websites.ddismart.com\/vistaar\/tag\/regulations\/\" rel=\"tag\">Regulations<\/a><\/div>","protected":false},"excerpt":{"rendered":"<p>Clinical Trial procedure for customized Medical Devices to undergo some supervisory and Administrative changes as per the announcement from CMDE China.<\/p>\n","protected":false},"author":1,"featured_media":1877,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[645],"tags":[91,90,89],"class_list":["post-1945","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device","tag-china","tag-medical-device","tag-regulations"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\r\n<title>New Regulatory Announcement from CMDE China<\/title>\r\n<meta name=\"description\" content=\"Clinical Trial procedure for customized Medical Devices to undergo some supervisory and Administrative changes as per the announcement from CMDE China.\" \/>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" 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