{"id":14484,"date":"2015-08-26T15:09:54","date_gmt":"2015-08-26T15:09:54","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=557"},"modified":"2023-02-09T11:45:09","modified_gmt":"2023-02-09T10:45:09","slug":"cfda-cfda-issues-working-procedures-for-the-audit-of-quality-management-systems-for-the-registration-of-medical-devices-2","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-cfda-issues-working-procedures-for-the-audit-of-quality-management-systems-for-the-registration-of-medical-devices-2\/","title":{"rendered":"CFDA: CFDA Issues Working Procedures for the Audit of Quality Management Systems for the Registration of Medical Devices"},"content":{"rendered":"<p><strong>Certain medical products and devices are required to have CFDA registration 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, used or traded in China. In an effort to insure safety and effectiveness of medical products, there have been numerous changes and revisions within the Chinese regulatory framework of the CFDA registration.<\/strong><\/p>\n<p>Recently the <strong>CFDA<\/strong> issued <strong>Working Procedures for the Audit of Quality Management Systems for the registration of Medical Devices<\/strong> in the \u201cDomestic Class III\u201d sector. The Working Procedures stipulate the work linkage between the CFDA technical evaluation institutions and provincial regulatory departments. They also set the formal framework of the auditing system including the required audit documents, the audit timeline, the audit results, and the relation between audit results and product registration evaluation.<\/p>\n<p>In an effort to control and increase the safety of medical devices in China, there have been many regulatory restructuring and revisions of the regulations in recent years. It is important that manufacturers stay up to date with the current regulations. Some of the more recent published updates are as follows:<\/p>\n<p>\u2022 March 2014 &#8211; The CFDA published a completely new version of their \u201c<strong><a href=\"https:\/\/china-certification.com\/en\/cfda-amended-regulations-pose-a-big-challenge-to-manufacturers-of-medical-devices\">Regulations for the Supervision and Administration of Medical Devices<\/a><\/strong>\u201d (Chinese: \u533b\u7597\u5668\u68b0 \u76d1\u7763\u7ba1\u7406\u6761\u4f8b(\u4fee\u8ba2\u8349\u6848)<br \/>\n\u2022 July 2014 &#8211; The CFDA launched &#8220;<strong>120 new industry standards for medical devices<\/strong>&#8221; (abbreviated as &#8220;YY-Standard&#8221;).<br \/>\n\u2022 2015 \u2013 The CFDA introduced <strong><a href=\"https:\/\/china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\">another 90 industry standards <\/a><\/strong> (you can find more information on these in our news section).<br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-2720 aligncenter\" src=\"https:\/\/china-certification.com\/wp-content\/uploads\/sites\/2\/2017\/10\/20150826151230782.jpg\" alt=\"medical healthcare test\" width=\"424\" height=\"283\" \/><strong>The purpose for these changes is to promote the positive development of China\u2019s medical equipment industry and to ensure the quality and safety of medical products.<\/strong> It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the future. In our \u201c<strong><a href=\"https:\/\/china-certification.com\/en\/news\">News<\/a><\/strong>\u201d section on our website, we will keep you informed regarding official announcements and changes to the regulations.<\/p>\n<p><strong>Please do not hesitate to call or <a href=\"mailto:info@china-certification.com\">email<\/a> with any questions you may have.<\/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 CFDA registration 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, used or traded in China. In an effort to insure safety and effectiveness of medical products, there have been numerous changes and revisions within the [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":2720,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[106],"tags":[],"class_list":["post-14484","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-further-topics"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CFDA: CFDA Issues Working Procedures for the Audit of Quality Management Systems for the Registration 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-working-procedures-for-the-audit-of-quality-management-systems-for-the-registration-of-medical-devices-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CFDA: CFDA Issues Working Procedures for the Audit of Quality Management Systems for the Registration of Medical Devices - MPR China Certification GmbH\" \/>\n<meta property=\"og:description\" content=\"Certain medical products and devices are required to have CFDA registration 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, used or traded in China. 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