{"id":1922,"date":"2015-08-20T12:26:28","date_gmt":"2015-08-20T12:26:28","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=555"},"modified":"2023-02-09T11:45:09","modified_gmt":"2023-02-09T10:45:09","slug":"cfda-cfda-issues-rules-for-classification-of-medical-devices","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-cfda-issues-rules-for-classification-of-medical-devices\/","title":{"rendered":"CFDA: CFDA Issues Rules for Classification of Medical Devices"},"content":{"rendered":"<p><strong>Certain medical products and devices are required to have prior approval by the CFDA (China Food and Drug Administration Chinese: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40) before they can be imported, bought, sold, traded or used in China.<\/strong> In an effort to insure continued safety and effectiveness of medical products there have been ongoing changes and revisions within the Chinese regulatory framework for CFDA certification.<\/p>\n<p><strong>The CFDA recently issued the Rules for Classification of Medical Devices (Order No. 15), which will be implemented as of January 1, 2016.<\/strong><\/p>\n<p>The new order discusses how risk-based classification of medical devices will be used not only for registration but also for device production and supervision. This includes revisions and clarifications to classifications, terms, and definitions of medical products and devices.<br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-2719 aligncenter\" src=\"https:\/\/china-certification.com\/wp-content\/uploads\/sites\/2\/2017\/10\/20150820122722442.jpg\" alt=\"Team of surgeons in the operating room, female surgeon holding s\" width=\"424\" height=\"283\" \/><\/p>\n<p><strong>It can be difficult for medical device manufacturers to determine if their products will require certification, and if so, in which classification their products should be categorized.<\/strong><\/p>\n<p>A complete evaluation of CFDA-responsibility and classification simplifies your registration process and prevents additional, unplanned costs.<\/p>\n<p>If you have any questions or concerns, please do not hesitate to <strong><a href=\"mailto:info@china-certification.com\">Email<\/a><\/strong> or <strong>call<\/strong> us: <strong>Germany: +49 69 271 3769 150, UK: +44 2071931135, US: +1 773 654 2673<\/strong><\/p>\n<p>&nbsp;<\/p>\n<div class=\"fb-like\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Certain medical products and devices are required to have prior approval by the CFDA (China Food and Drug Administration Chinese: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40) before they can be imported, bought, sold, traded or used in China. In an effort to insure continued safety and effectiveness of medical products there have been ongoing changes and revisions within the Chinese [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":2719,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[106],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CFDA: CFDA Issues Rules for Classification of Medical Devices - MPR China Certification GmbH<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.china-certification.com\/en\/cfda-cfda-issues-rules-for-classification-of-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CFDA: CFDA Issues Rules for Classification of Medical Devices - MPR China Certification GmbH\" \/>\n<meta property=\"og:description\" content=\"Certain medical products and devices are required to have prior approval by the CFDA (China Food and Drug Administration Chinese: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40) before they can be imported, bought, sold, traded or used in China. 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