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February 8, 2018
China accelerates medical device innovation. In January 2018, four products got approved through fast track pathway in January. United Imaging: medical linear accelerator system Edwards Lifesciences: transcatheter heart valve and […]
February 1, 2018
CFDA implements this 3-year plan to support central government’s effort to make medical device regulations more consistent with international standards. 300 standards for medical devices and IVDs could be expected […]
January 31, 2018
CFDA policies, regulation updates, QA/recall/AE, and new approvals in medical device and IVD for the week of Jan 22-29, 2018: 1. Policy: CFDA announced Comprehensive Regulatory Plan for Medical […]
January 30, 2018
On December 29th 2017, CFDA issued Circular No. 226 of 2017, redefining the attributes and categories of IV diagnostic reagent products such as allergens, FACS, immunohistochemistry and in situ hybridization. […]