{"id":14486,"date":"2015-09-03T13:13:37","date_gmt":"2015-09-03T13:13:37","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=561"},"modified":"2023-02-09T11:45:09","modified_gmt":"2023-02-09T10:45:09","slug":"cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/","title":{"rendered":"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices"},"content":{"rendered":"

The China Food and Drug Administration (CFDA<\/a>, chin: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40) recently formulated and issued three appendixes for good manufacturing practice for medical devices.<\/strong> The purpose is to strengthen the supervision and management of medical devices, improve enterprises’ quality management level, and to ensure the safety and effectiveness of medical devices.<\/p>\n

The three appendixes on Promulgation of Good Manufacturing Practice for Medical Devices are the following:<\/p>\n

    \n
  1. Appendix for Sterile Medical Devices<\/strong> (No. 101 Announcement of 2015)<\/li>\n
  2. Appendix for Implantable Medical Devices<\/strong> (No. 102 Announcement of 2015)<\/li>\n
  3. Appendix for In Vitro Diagnosis Reagents<\/strong> (No. 103 Announcement of 2015)<\/li>\n<\/ol>\n

    These appendixes were created in accordance with the \u201cRegulations for the Supervision and Administration of Medical Devices<\/a>” (chin: \u533b\u7597\u5668\u68b0 \u76d1\u7763\u7ba1\u7406\u6761\u4f8b(\u4fee\u8ba2\u8349\u6848) (State Council Decree No. 650) and the Administrative Measures for the Supervision of Medical Device Manufacturing<\/strong> (CFDA Order No. 7).<\/p>\n

    In the three appendixes, there is particular emphasis on the Good Manufacturing Practice of sterile medical devices, implantable medical devices and in vitro diagnosis reagents, which will come into effect as of October 1, 2015<\/strong>.
    \n\"ChineseIt is expected that there will be more announcements, reforms and changes to the CFDA regulations in the near future. In our     News section<\/a> on our website, we will keep you informed regarding the official announcements.<\/p>\n

    If you want to learn more about CFDA certification for medical devices and products, please visit the CFDA section<\/a><\/strong> on our website. We also provide more detailed knowledge regarding CFDA in our free brochure \u201cCFDA China \u2013 The Booklet\u201d<\/strong> that can be downloaded here<\/a><\/strong>.<\/p>\n

    Please do not hesitate to call (UK: +44 2071931135, Rest of Europe: +49 69 2713769150, US: +1 773 654-2673)<\/strong> or email<\/a> and we will be happy to answer questions.<\/p>\n

     <\/p>\n

    <\/div>\n","protected":false},"excerpt":{"rendered":"

    The China Food and Drug Administration (CFDA, chin: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40) recently formulated and issued three appendixes for good manufacturing practice for medical devices. The purpose is to strengthen the supervision and management of medical devices, improve enterprises’ quality management level, and to ensure the safety and effectiveness of medical devices. The three appendixes on Promulgation of […]<\/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-14486","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-further-topics"],"acf":[],"yoast_head":"\nCFDA Issues Three Appendixes for Good Manufacturing Practice for 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-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices - MPR China Certification GmbH\" \/>\n<meta property=\"og:description\" content=\"The China Food and Drug Administration (CFDA, chin: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40) recently formulated and issued three appendixes for good manufacturing practice for medical devices. The purpose is to strengthen the supervision and management of medical devices, improve enterprises’ quality management level, and to ensure the safety and effectiveness of medical devices. The three appendixes on Promulgation of […]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/\" \/>\n<meta property=\"og:site_name\" content=\"MPR China Certification GmbH\" \/>\n<meta property=\"article:published_time\" content=\"2015-09-03T13:13:37+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-02-09T10:45:09+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-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/\"},\"author\":{\"name\":\"Julian Busch\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\"},\"headline\":\"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices\",\"datePublished\":\"2015-09-03T13:13:37+00:00\",\"dateModified\":\"2023-02-09T10:45:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/\"},\"wordCount\":270,\"image\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/#primaryimage\"},\"thumbnailUrl\":\"\",\"articleSection\":[\"Further Topics\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/\",\"url\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/\",\"name\":\"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices - MPR China Certification GmbH\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/#primaryimage\"},\"thumbnailUrl\":\"\",\"datePublished\":\"2015-09-03T13:13:37+00:00\",\"dateModified\":\"2023-02-09T10:45:09+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/#primaryimage\",\"url\":\"\",\"contentUrl\":\"\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices\"}]},{\"@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 Issues Three Appendixes for Good Manufacturing Practice for Medical Devices - 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-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/","og_locale":"en_US","og_type":"article","og_title":"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices - MPR China Certification GmbH","og_description":"The China Food and Drug Administration (CFDA, chin: \u56fd\u5bb6\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u603b\u5c40) recently formulated and issued three appendixes for good manufacturing practice for medical devices. The purpose is to strengthen the supervision and management of medical devices, improve enterprises’ quality management level, and to ensure the safety and effectiveness of medical devices. The three appendixes on Promulgation of […]","og_url":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/","og_site_name":"MPR China Certification GmbH","article_published_time":"2015-09-03T13:13:37+00:00","article_modified_time":"2023-02-09T10:45:09+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-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/#article","isPartOf":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/"},"author":{"name":"Julian Busch","@id":"https:\/\/www.china-certification.com\/fr\/#\/schema\/person\/4f5cd923141741b7fe96721b17c464bf"},"headline":"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices","datePublished":"2015-09-03T13:13:37+00:00","dateModified":"2023-02-09T10:45:09+00:00","mainEntityOfPage":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/"},"wordCount":270,"image":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/#primaryimage"},"thumbnailUrl":"","articleSection":["Further Topics"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/","url":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/","name":"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices - MPR China Certification GmbH","isPartOf":{"@id":"https:\/\/www.china-certification.com\/fr\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/#primaryimage"},"image":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/#primaryimage"},"thumbnailUrl":"","datePublished":"2015-09-03T13:13:37+00:00","dateModified":"2023-02-09T10:45:09+00:00","author":{"@id":"https:\/\/www.china-certification.com\/fr\/#\/schema\/person\/4f5cd923141741b7fe96721b17c464bf"},"breadcrumb":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/#primaryimage","url":"","contentUrl":""},{"@type":"BreadcrumbList","@id":"https:\/\/www.china-certification.com\/en\/cfda-issues-three-appendixes-for-good-manufacturing-practice-for-medical-devices\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/www.china-certification.com\/en\/"},{"@type":"ListItem","position":2,"name":"CFDA Issues Three Appendixes for Good Manufacturing Practice for Medical Devices"}]},{"@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\/14486","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=14486"}],"version-history":[{"count":1,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/posts\/14486\/revisions"}],"predecessor-version":[{"id":18971,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/posts\/14486\/revisions\/18971"}],"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=14486"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/categories?post=14486"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/tags?post=14486"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}