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.
CFDA held industry forum for additive manufactured (3D printed) medical device. 70 technicians, manufacturers and CFDA reviewers attended the forum. Software issues, raw material powder issues, printer management and access requirements for 3D printed device were discussed for 3D printed device technical review draft guideline. Feedbacks need to be submitted by Mar 30. Read More
CFDA announced recall notices from 3 manufacturers:
- Philips: computed tomography x-ray system
- Smith & Nephew: surgical drill
- Becton Dickinson: Vacuum blood collection tube
CFDA announced imported medical device approval to 4 foreign manufacturers. GE and Johnson & Johnson are on the list.
- GE: computed tomography x-ray system
- Johnson & Johnson: high speed electric system
- Hill-Rom: electric bed
- Unimax Medical: nasal cannula
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.