{"id":14482,"date":"2015-08-03T08:52:19","date_gmt":"2015-08-03T08:52:19","guid":{"rendered":"https:\/\/www.china-certification.com\/en\/?page_id=538"},"modified":"2023-02-09T11:45:10","modified_gmt":"2023-02-09T10:45:10","slug":"cfda-cfda-issues-measures-for-unannounced-inspection-of-drugs-and-medical-devices","status":"publish","type":"post","link":"https:\/\/www.china-certification.com\/en\/cfda-cfda-issues-measures-for-unannounced-inspection-of-drugs-and-medical-devices\/","title":{"rendered":"CFDA: CFDA Issues Measures for Unannounced Inspection of Drugs and Medical Devices"},"content":{"rendered":"

Certain medical products and devices are required to have CFDA registration 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 imported, bought, sold, used or traded in China. In an effort to insure safety and effectiveness of medical products, there have been numerous changes and revisions within the Chinese regulatory framework of the CFDA registration.<\/strong><\/p>\n

The CFDA<\/strong> has recently issued the Measures for Unannounced Inspection of Drugs and Medical Devices<\/strong>, which will take effect on September 1, 2015<\/strong>. The measures comprises of 35 articles in five chapters, including the general provisions, initiating, inspection, handling and supplementary provisions. The measures provide that development, production, operation and the processing of drugs and medical devices are included in the scope of unannounced inspections.
\n\"asianThe goal of these inspections is to make sure that manufacturers stay up to date with the current regulations and to promote the positive development of China\u2019s medical equipment industry, ensuring the quality and safety of medical products.<\/p>\n

Some of the more recent published updates are as follows<\/strong>:<\/p>\n