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2023 China NMPA Bluebook is here:

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 accessory
  • Bohui: Repair patch with anastomotic stoma
  • RaySoultion: positron emission and X-ray tomography scanning 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.

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