February 8, 2018
Monthly Updates Digest from CFDA edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services. News coverage area: CFDA policies, regulations, […]
February 8, 2018
CFDA issued medical device recall reports to 16 manufactures from Jan 28th to Feb 3rd. There are six foreign manufacturers on the list: • Edwards Lifesciences: venous sheath • […]
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 […]