Weekly CFDA News Roundup covers policies, regulations, QA/recall/AE, and new approvals in medical device and IVD in China. It is edited by China Med Device, LLC, a consulting firm specializing in China CFDA regulatory, CRO and market access services.
Guideline
CFDA issued technical review guideline on optical coherence tomography system (final).
QA/Recall/AE
CFDA announced recall notice from 9 manufacturers. Among them are 6 foreign manufactures:
• Howmedica Osteonics: knee joint prostheses
• Boston Scientific: endoprosthesis stent
• Edwards: pericardial aortic bioprosthesis
• Roche: procalcitonin immunoassay
• Abbott: clinical laboratory analyzer
• Smith & Nephew: hinge knee joint
New Approval
• Shanghai CFDA office published approval notice to portable ECG recorder. The device is registered by Yuanxin Medtech and manufactured by MicroPort EP MedTech. It is the first approval granted through marketing-authorization holder program.
• CFDA published imported device approval notice to 13 foreign manufacturers. 伊藤超短波株式会社, Atmos Medizin Technik, Stryker are on the list.
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.