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.
QA/Recall/AE
- CFDA announced recall notices from 4 manufacturers:
- Edwards Lifesciences: transcatheter heart valve
- Boston Scientific: venous endoprosthesis
- Dako North America: trichrome stain kit
- Smith Medical ASD: intravascular administration set
- CFDA published adverse event notification for reusable uterine sound.
New Approval
CFDA announced innovation approvals to 7 medical devices, covering orthopedics, cardiology, hematology, oncology, etc. No foreign manufacturers are on the list. Read More
- Microport: eluting coronary stent
- Anhan Medtech: capsule endoscopy system
- Chunli Orthopedic: unicompartmental knee prosthesis
- Chunli Orthopedic: joint replacement prosthesis
- Origin Medtech: polymer clamp
- ZhiGeno: echinococcus spp. serological reagent
- NovoGene: EGFR t790m mutation reagent
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.