{"id":14461,"date":"2015-04-24T15:27:59","date_gmt":"2015-04-24T15:27:59","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=487"},"modified":"2023-02-09T11:45:16","modified_gmt":"2023-02-09T10:45:16","slug":"cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/","title":{"rendered":"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products"},"content":{"rendered":"<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 numerous changes and revisions within the Chinese regulatory framework for CFDA certification.<\/p>\n<p>In March of 2014 the CFDA published a completely 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).<\/p>\n<p>Previously in our \u201cNews\u201d section we informed you (<strong>\u201cCFDA Announces 120 New Industry Standards for Medical Products<\/strong>\u201d) that the CFDA introduced <strong>120 new Industry Standards<\/strong> (abbreviated as \u201cYY Standards\u201d) in announcement No. 30 dated July 3, 2014.<\/p>\n<p>On April 8, 2015 the CFDA has released announcement No. 8 which introduced another <strong>90 new Industry Standards <\/strong>for medical products. The announcement includes 14 mandatory and 76 recommended industry standards. The issuance of these changes will further improve the medical device standards system of China and help improve the overall quality of medical devices.<br \/>\n<img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-2695 aligncenter\" src=\"https:\/\/china-certification.com\/wp-content\/uploads\/sites\/2\/2017\/10\/20150424153203662.jpg\" alt=\"Portrait of two surgeons wearing surgical masks in the operating\" width=\"424\" height=\"283\" \/>The new standards apply to the following products:<\/p>\n<ul>\n<li>Implants for surgery<\/li>\n<li>Medical electrical equipment<\/li>\n<li>In vitro diagnostic reagents<\/li>\n<li>Dentistry<\/li>\n<\/ul>\n<p><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>News<\/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 <\/strong><a href=\"mailto:usa@china-certification.com\"><strong>email <\/strong><\/a><strong>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 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 numerous changes and revisions within the Chinese regulatory framework for [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":2695,"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-14461","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 Announces 90 Additional 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-cfda-announces-90-additional-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: CFDA Announces 90 Additional 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 numerous changes and revisions within the Chinese regulatory framework for [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/\" \/>\n<meta property=\"og:site_name\" content=\"MPR China Certification GmbH\" \/>\n<meta property=\"article:published_time\" content=\"2015-04-24T15:27:59+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-02-09T10:45:16+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=\"1 minute\" \/>\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-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/\"},\"author\":{\"name\":\"Julian Busch\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\"},\"headline\":\"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products\",\"datePublished\":\"2015-04-24T15:27:59+00:00\",\"dateModified\":\"2023-02-09T10:45:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/\"},\"wordCount\":269,\"image\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/#primaryimage\"},\"thumbnailUrl\":\"\",\"articleSection\":[\"Further Topics\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/\",\"url\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/\",\"name\":\"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products - MPR China Certification GmbH\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/#primaryimage\"},\"thumbnailUrl\":\"\",\"datePublished\":\"2015-04-24T15:27:59+00:00\",\"dateModified\":\"2023-02-09T10:45:16+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/#primaryimage\",\"url\":\"\",\"contentUrl\":\"\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#website\",\"url\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/\",\"name\":\"MPR China Certification GmbH\",\"description\":\"Consulting and Implementation of Certification Projects for China, Korea and India.\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\",\"name\":\"Julian Busch\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6fee0d05478aa57d981a6df656f31db4d333de96110871cea6b777cef378a3a2?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6fee0d05478aa57d981a6df656f31db4d333de96110871cea6b777cef378a3a2?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/6fee0d05478aa57d981a6df656f31db4d333de96110871cea6b777cef378a3a2?s=96&d=mm&r=g\",\"caption\":\"Julian Busch\"},\"description\":\"About the author: Louis Gogger is Managing Director of MPR China Certification GmbH Publisher: MPR China Certification GmbH Tel.: +49 69 271 37 69 150 E-Mail: info@china-certification.com Web: www.china-certification.com\",\"url\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/author\\\/julian-busch\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products - MPR China Certification GmbH","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/","og_locale":"en_US","og_type":"article","og_title":"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products - MPR China Certification GmbH","og_description":"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 numerous changes and revisions within the Chinese regulatory framework for [&hellip;]","og_url":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/","og_site_name":"MPR China Certification GmbH","article_published_time":"2015-04-24T15:27:59+00:00","article_modified_time":"2023-02-09T10:45:16+00:00","author":"Julian Busch","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Julian Busch","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/#article","isPartOf":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/"},"author":{"name":"Julian Busch","@id":"https:\/\/www.china-certification.com\/fr\/#\/schema\/person\/4f5cd923141741b7fe96721b17c464bf"},"headline":"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products","datePublished":"2015-04-24T15:27:59+00:00","dateModified":"2023-02-09T10:45:16+00:00","mainEntityOfPage":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/"},"wordCount":269,"image":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/#primaryimage"},"thumbnailUrl":"","articleSection":["Further Topics"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/","url":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/","name":"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products - MPR China Certification GmbH","isPartOf":{"@id":"https:\/\/www.china-certification.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/#primaryimage"},"image":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/#primaryimage"},"thumbnailUrl":"","datePublished":"2015-04-24T15:27:59+00:00","dateModified":"2023-02-09T10:45:16+00:00","author":{"@id":"https:\/\/www.china-certification.com\/fr\/#\/schema\/person\/4f5cd923141741b7fe96721b17c464bf"},"breadcrumb":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/#primaryimage","url":"","contentUrl":""},{"@type":"BreadcrumbList","@id":"https:\/\/www.china-certification.com\/en\/cfda-cfda-announces-90-additional-new-industry-standards-for-medical-products\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/www.china-certification.com\/en\/"},{"@type":"ListItem","position":2,"name":"CFDA: CFDA Announces 90 Additional New Industry Standards for Medical Products"}]},{"@type":"WebSite","@id":"https:\/\/www.china-certification.com\/fr\/#website","url":"https:\/\/www.china-certification.com\/fr\/","name":"MPR China Certification GmbH","description":"Consulting and Implementation of Certification Projects for China, Korea and India.","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.china-certification.com\/fr\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.china-certification.com\/fr\/#\/schema\/person\/4f5cd923141741b7fe96721b17c464bf","name":"Julian Busch","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/6fee0d05478aa57d981a6df656f31db4d333de96110871cea6b777cef378a3a2?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/6fee0d05478aa57d981a6df656f31db4d333de96110871cea6b777cef378a3a2?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/6fee0d05478aa57d981a6df656f31db4d333de96110871cea6b777cef378a3a2?s=96&d=mm&r=g","caption":"Julian Busch"},"description":"About the author: Louis Gogger is Managing Director of MPR China Certification GmbH Publisher: MPR China Certification GmbH Tel.: +49 69 271 37 69 150 E-Mail: info@china-certification.com Web: www.china-certification.com","url":"https:\/\/www.china-certification.com\/en\/author\/julian-busch\/"}]}},"_links":{"self":[{"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/posts\/14461","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/comments?post=14461"}],"version-history":[{"count":1,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/posts\/14461\/revisions"}],"predecessor-version":[{"id":19001,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/posts\/14461\/revisions\/19001"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/media?parent=14461"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/categories?post=14461"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/tags?post=14461"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}