CFDA quality requirements have escalated. From Mar 18 to Mar 24, CFDA announced Medical Device Recall Notices from 17 foreign manufacturers for 22 medical devices. Boston Scientific, Siemens, Becton Dickinson, GE, Smith & Nephew are on the list.
If you are not clear about CFDA recall process, or need model information and reasons for recall, email gpalma@ChinaMedDevice.com
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.