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CATÉGORIE: REGULATORY PATHWAYS

Titulaire d'autorisation de mise sur le marché (MAH)

L'entité juridique détenant l'autorisation réglementaire de commercialiser un dispositif médical dans une juridiction spécifique.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

In China, the Marketing Authorization Holder (MAH) is the legal entity responsible for device registration and post-market duties. Foreign manufacturers generally cannot hold NMPA certificates directly.

PROCESS / STEPS

  1. Select a qualified Chinese MAH partner or establish a local entity.
  2. Define contractual duties for registration, vigilance, and quality agreements.
  3. Submit dossiers under MAH identity; maintain change notifications.

EXAMPLES

  • A US OEM appoints a Chinese MAH for Class II registration and AE reporting.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

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