{"id":14448,"date":"2015-02-20T08:29:01","date_gmt":"2015-02-20T08:29:01","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=454"},"modified":"2023-02-09T11:43:50","modified_gmt":"2023-02-09T10:43:50","slug":"cfda-new-regulation-published-for-quality-management-of-medical-devices","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-new-regulation-published-for-quality-management-of-medical-devices\/","title":{"rendered":"CFDA: New Regulation Published for Quality Management of Medical Devices"},"content":{"rendered":"<p>An ageing population and improved living standards have created a strong demand for medical devices in China. The safety of those products is ensured by <strong>the China Food and Drug Administration<\/strong> (<strong><a href=\"https:\/\/china-certification.com\/en\/cfda-chinese-medical\">CFDA<\/a><\/strong>, chin: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40). At the 16th and 17th minister\u2019s working meeting new and revised regulations governing the good practices in supply and medical device manufacturing were adopted. The new requirements are aimed at improving the quality and safety of related medical products.<br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-2565 aligncenter\" src=\"https:\/\/china-certification.com\/wp-content\/uploads\/sites\/2\/2017\/10\/20140411141645795.jpg\" alt=\"Team of surgeons in the operating room, female surgeon holding\" width=\"424\" height=\"283\" \/>The new supply practice went into effect <strong>December 12, 2014<\/strong> and includes 66 articles in 9 chapters. The new requirements are in regards to the quality management of companies producing medical devices. There are more stringent control process covering the purchase, acceptance, storage, sales, transportation and the after-sales service of medical devices.<\/p>\n<p>The revised practice for manufacturing medical devises includes 84 articles in 13 chapters and will go into effect <strong>March 1, 2015<\/strong>. The new requirements are aimed at improved quality management at the manufacturing level. These requirements cover personnel, manufacturing facilities, manufacturing equipment, document management, product design and development, procurement, production management, quality control, sales, after-sales service, control of non-conforming products, adverse event monitoring and more.<br \/>\nIt is the responsibility of the manufacturer of medical devices to keep up to date with the latest regulations and to maintain compliance. Manufacturers found out of compliance risk fines and\/or suspension or revocation of their CFDA registration. To avoid this, it is important to check the revised practices against your current procedures.<\/p>\n<p><strong>As soon as new announcements or information by the CFDA becomes available, we will provide the information in our <strong><a href=\"https:\/\/china-certification.com\/en\/news\">News-Area<\/a><\/strong>. There you can find all relevant information published by other Chinese authorities<\/strong>.<\/p>\n<p>Do you need more information about certifying medical devices through the CFDA? Learn more at our <strong><a href=\"https:\/\/china-certification.com\/en\/cfda-chinese-medical\">CFDA-Area<\/a><\/strong> on our homepage. For more detailed information you can download our <strong><a title=\"\" href=\"https:\/\/china-certification.com\/en\/cfda-booklet\">\u201cCFDA booklet\u201d<\/a><\/strong> free of charge.<\/p>\n<p>If you would like to know more, have questions or concerns, please contact us any time by phone or <strong><a href=\"mailto:usa@china-certification.com\">email <\/a><\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<div class=\"fb-like\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>An ageing population and improved living standards have created a strong demand for medical devices in China. The safety of those products is ensured by the China Food and Drug Administration (CFDA, chin: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40). At the 16th and 17th minister\u2019s working meeting new and revised regulations governing the good practices in supply and medical device [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":2565,"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-14448","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 v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CFDA: New Regulation Published for Quality Management 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-new-regulation-published-for-quality-management-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: New Regulation Published for Quality Management of Medical Devices - MPR China Certification GmbH\" \/>\n<meta property=\"og:description\" content=\"An ageing population and improved living standards have created a strong demand for medical devices in China. The safety of those products is ensured by the China Food and Drug Administration (CFDA, chin: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40). At the 16th and 17th minister\u2019s working meeting new and revised regulations governing the good practices in supply and medical device [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.china-certification.com\/en\/cfda-new-regulation-published-for-quality-management-of-medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"MPR China Certification GmbH\" \/>\n<meta property=\"article:published_time\" content=\"2015-02-20T08:29:01+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-02-09T10:43:50+00:00\" \/>\n<meta name=\"author\" content=\"Julian Busch\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Julian Busch\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-new-regulation-published-for-quality-management-of-medical-devices\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-new-regulation-published-for-quality-management-of-medical-devices\\\/\"},\"author\":{\"name\":\"Julian Busch\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\"},\"headline\":\"CFDA: New Regulation Published for Quality Management of Medical Devices\",\"datePublished\":\"2015-02-20T08:29:01+00:00\",\"dateModified\":\"2023-02-09T10:43:50+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-new-regulation-published-for-quality-management-of-medical-devices\\\/\"},\"wordCount\":332,\"image\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-new-regulation-published-for-quality-management-of-medical-devices\\\/#primaryimage\"},\"thumbnailUrl\":\"\",\"articleSection\":[\"Further Topics\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-new-regulation-published-for-quality-management-of-medical-devices\\\/\",\"url\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-new-regulation-published-for-quality-management-of-medical-devices\\\/\",\"name\":\"CFDA: New Regulation Published for Quality Management of Medical Devices - 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