China's National Medical Products Administration regulates one of the world's largest and fastest-growing medical device markets. For international manufacturers seeking to enter China, obtaining NMPA registration is not merely a regulatory requirement — it is a strategic imperative. The NMPA has been continuously refining its regulatory framework, aimed at providing manufacturers with greater clarity in type testing, non-clinical and clinical evaluation, and regulatory submission.

Our NMPA Services

l Registration Strategy Consulting — Comprehensive pathway analysis for Class I, II, and III devices, including classification determination and regulatory roadmap development

l Technical Document Preparation — Compilation and translation of all required submission dossiers in compliance with NMPA requirements

l Type Testing Coordination — Liaison with NMPA-designated testing laboratories for product type testing

l Clinical Evaluation — Preparation of clinical evaluation reports (CER) and, where required, clinical trial management in China

l Submission & Follow-up — Complete management of the submission process, including responding to NMPA review questions and supplementary requests

l Registration Certificate Maintenance — Renewal and post-market compliance support

Import Registration for Foreign Manufacturers

For overseas medical device manufacturers, China requires a domestic agent or legal entity to handle registration affairs. HLONGMED serves as the authorized representative for numerous international companies, providing:

l Qualified Person / Agent Services — Acting as the legal agent for foreign manufacturers with NMPA

l Dossier Localization — Adapting existing regulatory submissions (FDA, CE, etc.) to NMPA requirements

l GMP Inspection Support — Preparation and on-site support for NMPA GMP inspections of manufacturing facilities

l Post-Market Obligations — Adverse event reporting, recall coordination, and ongoing compliance monitoring

With deep expertise in both international regulatory systems and NMPA requirements, HLONGMED bridges the gap between global standards and Chinese regulatory expectations. Our team maintains close working relationships with NMPA review centers and testing laboratories, enabling efficient navigation of the registration process.