China Med Device

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 and 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. 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: Regulatory • Registration, renewal and modification • Quality Management System (QMS) • Postmarket surveillance / Local Agent representation Clinical Research Organization (CRO) • Clinical trial management / CER • Overseas clinical data acceptance • Real World Data / Evidence (RWD/E) Business • China market assessment and due diligence • Reimbursement analysis Device Types • Class I – active/passive, implants software/SaMD, combination products • IVD/Diagnostics: reagents, CDx, systems, test kits, assays • Clinical indications: orthopedics, ophthalmology, cardiovascular, IVF, oncology, radiology, imaging Get FREE news and updates. Follow us on LinkedIn for the latest China news and invitations to our free webinars.