6 Foreign Devices Recalled Last Week

Edwards Lifesciences got innovation approval from China CFDA
February 8, 2018
Monthly CFDA News Roundup (January 2018)
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

•             Hologic, Inc: nucleic acid detection system

•             Boston Scientific: implantable pacing lead

•             Biomet Orthopedics: shoulder joint prosthesis

•             Smith & Nephew: external fixation system

•             Philips Medical Systems: tomography X-ray system 

 

About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.