{"id":151,"date":"2013-11-06T15:31:43","date_gmt":"2013-11-06T15:31:43","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=151"},"modified":"2024-08-29T18:55:12","modified_gmt":"2024-08-29T16:55:12","slug":"cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/","title":{"rendered":"CFDA: Changes in requirement for the approval of medical devices for the P.R. China"},"content":{"rendered":"\n<p>Certain medical products and medical devices must be certified and registered by the China Food and Drug Administration (CFDA) before they can be exported to China. Until recently, CCC certification at CQC was also required for some of these products. The AQSIQ changed this policy with \u201cAnnouncement 52\u201d in April 2013, no longer requiring CCC certification (with the CQC) for medical products and devices as of May 2013. All certification for medical products and devices now falls under the CFDA certification and registration process.<br>This change affected the following devices: Implantable Pacemakers, Rubber Condoms, ECG Devices, Artificial heart-lung Machines, Extracorporeal Blood Circuit for Blood Purification Equipment, Hollow Fiber Dialyzers, Hemodialysis Equipment, Medical Diagnostic X-Ray Equipment.<br>Please click here for more information about <a href=\"https:\/\/china-certification.com\/en\/cfda-chinese-medical\">CFDA<\/a>.<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<br>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Certain medical products and medical devices must be certified and registered by the China Food and Drug Administration (CFDA) before they can be exported to China. Until recently, CCC certification at CQC was also required for some of these products. The AQSIQ changed this policy with \u201cAnnouncement 52\u201d in April 2013, no longer requiring CCC [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[106],"tags":[],"class_list":["post-151","post","type-post","status-publish","format-standard","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: Changes in requirement for the approval of medical devices for the P.R. China - 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-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CFDA: Changes in requirement for the approval of medical devices for the P.R. China - MPR China Certification GmbH\" \/>\n<meta property=\"og:description\" content=\"Certain medical products and medical devices must be certified and registered by the China Food and Drug Administration (CFDA) before they can be exported to China. Until recently, CCC certification at CQC was also required for some of these products. The AQSIQ changed this policy with \u201cAnnouncement 52\u201d in April 2013, no longer requiring CCC [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/\" \/>\n<meta property=\"og:site_name\" content=\"MPR China Certification GmbH\" \/>\n<meta property=\"article:published_time\" content=\"2013-11-06T15:31:43+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-08-29T16:55:12+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-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/\"},\"author\":{\"name\":\"Julian Busch\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\"},\"headline\":\"CFDA: Changes in requirement for the approval of medical devices for the P.R. China\",\"datePublished\":\"2013-11-06T15:31:43+00:00\",\"dateModified\":\"2024-08-29T16:55:12+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/\"},\"wordCount\":155,\"commentCount\":0,\"articleSection\":[\"Further Topics\"],\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/\",\"url\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/\",\"name\":\"CFDA: Changes in requirement for the approval of medical devices for the P.R. China - MPR China Certification GmbH\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#website\"},\"datePublished\":\"2013-11-06T15:31:43+00:00\",\"dateModified\":\"2024-08-29T16:55:12+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/fr\\\/#\\\/schema\\\/person\\\/4f5cd923141741b7fe96721b17c464bf\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/www.china-certification.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"CFDA: Changes in requirement for the approval of medical devices for the P.R. China\"}]},{\"@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: Changes in requirement for the approval of medical devices for the P.R. China - 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-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/","og_locale":"en_US","og_type":"article","og_title":"CFDA: Changes in requirement for the approval of medical devices for the P.R. China - MPR China Certification GmbH","og_description":"Certain medical products and medical devices must be certified and registered by the China Food and Drug Administration (CFDA) before they can be exported to China. Until recently, CCC certification at CQC was also required for some of these products. The AQSIQ changed this policy with \u201cAnnouncement 52\u201d in April 2013, no longer requiring CCC [&hellip;]","og_url":"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/","og_site_name":"MPR China Certification GmbH","article_published_time":"2013-11-06T15:31:43+00:00","article_modified_time":"2024-08-29T16:55:12+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-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/#article","isPartOf":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/"},"author":{"name":"Julian Busch","@id":"https:\/\/www.china-certification.com\/fr\/#\/schema\/person\/4f5cd923141741b7fe96721b17c464bf"},"headline":"CFDA: Changes in requirement for the approval of medical devices for the P.R. China","datePublished":"2013-11-06T15:31:43+00:00","dateModified":"2024-08-29T16:55:12+00:00","mainEntityOfPage":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/"},"wordCount":155,"commentCount":0,"articleSection":["Further Topics"],"inLanguage":"en-US","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/","url":"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/","name":"CFDA: Changes in requirement for the approval of medical devices for the P.R. China - MPR China Certification GmbH","isPartOf":{"@id":"https:\/\/www.china-certification.com\/fr\/#website"},"datePublished":"2013-11-06T15:31:43+00:00","dateModified":"2024-08-29T16:55:12+00:00","author":{"@id":"https:\/\/www.china-certification.com\/fr\/#\/schema\/person\/4f5cd923141741b7fe96721b17c464bf"},"breadcrumb":{"@id":"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.china-certification.com\/en\/cfda-changes-in-requirement-for-the-approval-of-medical-devices-for-the-p-r-china\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/www.china-certification.com\/en\/"},{"@type":"ListItem","position":2,"name":"CFDA: Changes in requirement for the approval of medical devices for the P.R. China"}]},{"@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\/151","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=151"}],"version-history":[{"count":2,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/posts\/151\/revisions"}],"predecessor-version":[{"id":23989,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/posts\/151\/revisions\/23989"}],"wp:attachment":[{"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/media?parent=151"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/categories?post=151"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.china-certification.com\/en\/wp-json\/wp\/v2\/tags?post=151"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}