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 (CMD) provides the regulatory, CRO, and market intelligence to help companies access China’s fast-growing $80-billion MedTech market. CMD has partnered to create over 1,200 success stories for manufacturers of medical devices, IVDs, combination products and more.
U.S. and European companies can be frustrated by China’s National Medical Products Administration (NMPA), a regulatory system that differs greatly from FDA, EU and other international markets. CMD focuses solely on China, so we can help companies overcome regulatory hurdles as well as significant language and cultural differences that can impact your business.
Our team has decades of clinical/technical experience, previously working for MedTech companies or in auditing roles with regulatory agencies. This deeper understanding of medical device development and how NMPA applies requirements in real life allows CMD to deliver clear guidance and practical solutions.
Why Choose CMD
- 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 the U.S. (Boston) and China (Beijing)
Which Services We Can Support You With
CMD has offices in both Boston and Beijing to give our clients quick access to a local, bilingual and bicultural team. Count on CMD as your partner throughout the complete product life cycle. Here are our key services and areas of expertise:
- Registration, renewal and modification
- Local type testing coordination
- Quality Management System (QMS)
- Post-market surveillance/Local Agent representation
Clinical Research Organization (CRO)
- Clinical trial management / CER
- Overseas clinical data acceptance
- Real-World Data / Evidence (RWD/E)
Business & Commercialization
- China market assessment and due diligence
- Reimbursement analysis
- Class I – III, active/passive, implants software/SaMD, combination products
- IVD/Diagnostics: reagents, CDx, systems, test kits, assays
- Clinical indications: orthopedics, ophthalmology, cardiovascular, IVF, oncology, radiology, imaging