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Marketing Authorization Holders (MAH)

JP-unique

The MAH (製造販売業者 — Seizouhanbaigyo-sha) requirement — that a Japan-domiciled entity must hold every device approval or certification — has no direct parallel in EU MDR, US FDA, or Australian TGA frameworks, where overseas manufacturers can hold authorisations directly.

What an MAH is​

The MAH is the legal entity in Japan that:

  1. Holds the Shonin (approval), Ninsho (certification), or Todokede (notification) for a device
  2. Bears primary regulatory responsibility for the device throughout its market life
  3. Is the entity to which MHLW and PMDA direct all communications regarding the device

The MAH must hold an MAH business licence issued by the prefectural government (or MHLW for certain higher-risk categories). The licence requires a physical business presence in Japan.

What an MAH is not​

An MAH is not necessarily the manufacturer. For most overseas manufacturers, the MAH is a separate Japan-based entity — either a subsidiary, a trading company, or a specialist regulatory service company — that acts on their behalf.

An MAH is also not a representative or agent in the EU/US sense. The MAH is the legal licence holder with full regulatory responsibility. If there is a recall, MHLW communicates with the MAH, not the overseas manufacturer.

Core MAH obligations​

The MAH is responsible under the PMD Act for:

  • Pre-market: preparing and submitting the Shonin/Ninsho application; obtaining and maintaining the approval
  • Quality oversight: establishing contracts with manufacturers; overseeing their QMS compliance under MO 169; conducting supplier audits
  • Post-market surveillance: operating a GPSP programme; collecting use-results data; submitting re-examination applications
  • Adverse event reporting: receiving reports from healthcare settings; filing reports to MHLW within statutory timelines
  • Recalls: notifying MHLW; executing and documenting recall actions; verifying effectiveness
  • Labelling: ensuring labels and IFUs comply with MHLW requirements; maintaining labelling change records
  • Regulatory submissions: filing Ichibu Henko (partial change approvals) and minor change notifications when the device or its manufacturing changes

MAH vs manufacturer — the split​

In Japan's model, the MAH and manufacturer can be the same company, or they can be different companies with a contractual relationship. When they are different:

  • The manufacturer is responsible for production, QMS at the manufacturing site, and product conformity
  • The MAH is responsible for the regulatory approval, post-market surveillance programme, adverse event reporting, and regulatory submissions

This split is codified in MHLW guidance and requires a formal contract between the MAH and the manufacturer setting out each party's responsibilities.