Blogs

CFDA has a new requirement that foreign applicants, registrants and filers shall use Chinese languages for company name in medical device registration. The Chinese company name should meet the following […]

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, […]

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 •             […]

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 […]

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 […]