We provide turn-key solutions for Western medical device & In-Vitro Diagnostic companies with NMPA (CFDA) regulatory and commercialization services in China.
Accelerating western medtech companies’ entry into China.
China Med Device, LLC provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirements (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification. As a qualified NMPA legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Why Choose Us:
- 100+ year of combined management team experience
- 1000+ NMPA certificates issued
- Integrated regulatory, technical and clinical team approach
- Proven bilingual, bicultural international project management
- Extensive relationships with NMPA and China KOLs
- Office located in U.S. (Boston) and China (Beijing)