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CATEGORY: REGULATORY PATHWAYS

Marketing Authorization Holder (MAH)

The legal entity holding regulatory approval to market a medical device in a specific jurisdiction. In China (NMPA) and Japan (PMDA), foreign manufacturers must appoint a local MAH/DMAL holder.

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

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RELATED TERMS

Authorized Representative