{"id":1940,"date":"2016-05-20T13:28:34","date_gmt":"2016-05-20T13:28:34","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=662"},"modified":"2024-03-27T17:49:17","modified_gmt":"2024-03-27T16:49:17","slug":"cfda-announces-186-new-industry-standards-for-medical-products","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-announces-186-new-industry-standards-for-medical-products\/","title":{"rendered":"CFDA Announces 186 New Industry Standards for Medical Products"},"content":{"rendered":"\n<p><strong>Certain medical products and devices are required to have prior approval by the CFDA (China Food and Drug Administration Chinese: <\/strong><strong>\u56fd\u5bb6\u98df\u54c1<\/strong><strong>\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40<\/strong><strong>) before they can be sold or used in China.<\/strong> In an effort to insure continued safety and effectiveness of medical products, there have been several changes and revisions within the Chinese regulatory framework for CFDA certification.<br>In March of 2014 the CFDA published a new version of the <a href=\"https:\/\/china-certification.com\/en\/cfda-amended-regulations-pose-a-big-challenge-to-manufacturers-of-medical-devices\"><strong>\u201cRegulations for the Supervision and Administration of Medical Devices\u201d<\/strong><\/a> (Chinese: \u533b\u7597\u5668\u68b0 \u76d1\u7763\u7ba1\u7406\u6761\u4f8b(\u4fee\u8ba2\u8349\u6848). In its announcement No. 25 and No. 74 of 2016 the CFDA introduced <strong>186 new Industry Standards<\/strong> (abbreviated as \u201cYY Standards\u201d). These industry standards are split in 42 mandatory and 144 recommended standards. However, recommended changes are often a precursor to future mandatory changes to come. Compliance with these new recommended \u201cYY\u201d standards is highly recommended since they may become mandatory at any time with very short notice.<br><br>The new standards apply to the following products:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Implants for surgery<\/li>\n\n\n\n<li>Disinfection equipment<\/li>\n\n\n\n<li>Medical extracorporeal circulation equipment<\/li>\n\n\n\n<li>Dental equipment<\/li>\n\n\n\n<li>Ophthalmic equipment<\/li>\n<\/ul>\n\n\n\n<p><strong>The purpose for these changes is to promote further improvement of China&#8217;s medical device standards system, and build a solid foundation for ensuring the safety and effectiveness of medical devices.<\/strong> It is expected that there will be more announcements, reforms and changes to the CFDA regulations in the future.<br>\u00a0<\/p>\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 sold or used in China. In an effort to insure continued safety and effectiveness of medical products, there have been several changes and revisions within the Chinese regulatory framework for [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":2722,"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-1940","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 Announces 186 New Industry Standards for Medical Products - 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-announces-186-new-industry-standards-for-medical-products\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CFDA Announces 186 New Industry Standards for Medical Products - 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 sold or used in China. In an effort to insure continued safety and effectiveness of medical products, there have been several changes and revisions within the Chinese regulatory framework for [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.china-certification.com\/en\/cfda-announces-186-new-industry-standards-for-medical-products\/\" \/>\n<meta property=\"og:site_name\" content=\"MPR China Certification GmbH\" \/>\n<meta property=\"article:published_time\" content=\"2016-05-20T13:28:34+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-03-27T16:49:17+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-announces-186-new-industry-standards-for-medical-products\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-announces-186-new-industry-standards-for-medical-products\\\/\"},\"author\":{\"name\":\"Julian Busch\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\"},\"headline\":\"CFDA Announces 186 New Industry Standards for Medical Products\",\"datePublished\":\"2016-05-20T13:28:34+00:00\",\"dateModified\":\"2024-03-27T16:49:17+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-announces-186-new-industry-standards-for-medical-products\\\/\"},\"wordCount\":218,\"image\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-announces-186-new-industry-standards-for-medical-products\\\/#primaryimage\"},\"thumbnailUrl\":\"\",\"articleSection\":[\"Further Topics\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-announces-186-new-industry-standards-for-medical-products\\\/\",\"url\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-announces-186-new-industry-standards-for-medical-products\\\/\",\"name\":\"CFDA Announces 186 New Industry Standards for Medical Products - 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