{"id":4386,"date":"2017-07-13T12:37:02","date_gmt":"2017-07-13T10:37:02","guid":{"rendered":"http:\/\/www.thema-med.com\/china-descubre-los-secretos-de-la-directriz-2016-para-los-dispositivos-x-ray\/"},"modified":"2023-01-24T14:59:49","modified_gmt":"2023-01-24T13:59:49","slug":"china-discover-the-secrets-of-the-2016-guideline-on-x-ray-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2017\/07\/13\/china-discover-the-secrets-of-the-2016-guideline-on-x-ray-devices\/","title":{"rendered":"CHINA: discover the secrets of the 2016 guideline on X-ray devices!"},"content":{"rendered":"<p>Knowing how to register a device in <a href=\"http:\/\/www.thema-med.com\/es\/registrazione-di-un-dispositivo-medico-in-cina\/\">China<\/a> is more and more difficult: finding texts is an mission impossible and even if some information is available, well, \u00a0it is in Chinese!<\/p>\n<p>And regarding class I radiation-emitting devices of (Attention! The classification is the Chinese one), the going gets though.<\/p>\n<p>However, we did succeed and we managed to find the guideline on class III X-ray devices registration with CFDA,\u00a0 last update in 2016.<\/p>\n<p>This guideline shows how to prepare and elaborate the dossier for such devices, to be submitted to the Chinese Regulatory Authority,\u00a0 and it provides also instructions for a proper documentation review.<\/p>\n<p>The guideline applies to class III X-ray devices for angiography, fluoroscopy and C-arms.<\/p>\n<p>The document is the 2010 Product Registration Guidance of Medical X \u2013 ray Diagnostic (Class III) Equipment for Technical Review <strong>revised version<\/strong> and the changes included refer to the following <strong>eight<\/strong> points:<\/p>\n<ol>\n<li><em>\u00a0<\/em>the content adjustment to the Notification on publishing the requirements for application documents of medical devices and the format of approval documents (CFDA NO.43 of 2014);<\/li>\n<li>the scope review;<\/li>\n<li>the introduction of the documents summary to be submitted for registration;<\/li>\n<li>extension of the requirements for the documentation to be submitted;<\/li>\n<li>the Technical Guidance for clinical evaluation of medical devices requirements adjustment;<\/li>\n<li>need to carry out on-site clinical trials \u00a0for interventional devices ;<\/li>\n<li>introduction of new technical product requirements (including the Chinese standards);<\/li>\n<li>changes to the classification.<\/li>\n<\/ol>\n<p>Therefore, if the medical device to be registered in the Chinese market is an X-ray device,\u00a0 the registration procedure is quite complex but it reserves success and satisfaction if you are ready to take up the challenge!<\/p>\n<p>Do you want other information about China? Go to the section Countries <a href=\"http:\/\/www.thema-med.com\/en\/registrazione-di-un-dispositivo-medico-in-cina\/\">China<\/a>.<\/p>\n<p>Do you want to keep up to date with Thema\u2019s work? Subscribe to our <a href=\"http:\/\/www.thema-med.com\/en\/newsletter\/\"><strong>newsletter<\/strong><\/a>!<\/p>\n<p style=\"text-align: justify;\"><strong><img decoding=\"async\" class=\" wp-image-10 alignleft\" src=\"https:\/\/publicationsthema.files.wordpress.com\/2012\/08\/thema-logo-trasparente_small.png\" alt=\"THEMA - Logo TRASPARENTE_small\" width=\"51\" height=\"51\" \/><\/strong><\/p>\n<p><em><strong>Marisa Testa<\/strong><strong><br \/>\n<\/strong>QA\/RA Manager<\/em><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Knowing how to register a device in China is more and more difficult: finding texts is an mission impossible and even  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[679,2],"tags":[],"class_list":["post-4386","post","type-post","status-publish","format-standard","hentry","category-blog-en","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CHINA: discover the secrets of the 2016 guideline on X-ray devices!<\/title>\n<meta name=\"description\" content=\"Knowing how to register a device in China is more and more difficult: finding texts is an mission impossible and even if some information is available...\" \/>\n<meta name=\"robots\" content=\"index, follow, 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