CFDA Updates

February 8, 2018

CFDA: Be Prepared to Have Company Name in Chinese on Your Device Label

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 […]
February 8, 2018

Monthly CFDA News Roundup (January 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

6 Foreign Devices Recalled Last Week

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

Edwards Lifesciences got innovation approval from China CFDA

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

Chinese Central Government Wants to Reach Medical Device International Standardization Faster

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 […]