About us

BiomenGroup – Your China Access Partner

BiomenGroup empowers global MedTech innovators to enter the Chinese market with confidence. Leveraging our deep regulatory expertise and local resources, we provide comprehensive support for imported medical devices seeking NMPA approval, helping clients navigate one of the most complex regulatory systems in the world.
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Core Services/strength

NMPA Registration
Strategic guidance for device classification, submission planning, and end-to-end regulatory execution.
Technical & Clinical Dossiers
Expert support for preparing NMPA-compliant dossiers and clinical evidence.
Localization Strategy
Become a domestic manufacturer through local partnerships or OEM.
Market Access & Tendering
Post-approval support for distribution, hospital listing, and provincial tenders.
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2025.07.18

Global Certification: Registered with China's NMPA

In China, the regulatory authorities for medical devices are the National Medical Products Administration and the drug regulatory authorities at the provincial and municipal levels. The National Medical Products Administration is abbreviated as NMPA.