China accelerates medical device innovation. In February 2018, 7 products got approved through fast track pathway. Among them are two from Chunli Orthopedic, based in Beijing. No foreign manufacturers are on the list.
- 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
For January innovation approvals, please click HERE.
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.