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MAH vs Manufacturer — Splitting Responsibilities

The two-entity model in practice​

In Japan, the MAH and the manufacturer can be the same company, or they can be entirely different companies. For overseas manufacturers using a Kannin MAH, they are always different companies. MO 169 and the PMD Act explicitly contemplate this split and require the relationship to be governed by a formal contract.

What the manufacturer controls​

The manufacturer (overseas or domestic) is responsible for:

  • Manufacturing the device to the agreed specification
  • Maintaining the QMS at the manufacturing site to MO 169 standards
  • Manufacturing site FMR compliance
  • Implementing design and manufacturing changes within the agreed framework
  • Notifying the MAH promptly of any events that might trigger regulatory action (adverse events, changes, overseas regulatory actions, quality issues)

What the MAH controls​

The MAH (Japan-domiciled) controls:

  • All regulatory submissions in Japan (Shonin application, change applications, notifications)
  • All communications with MHLW and PMDA
  • Adverse event reporting to MHLW
  • Recall management in Japan
  • Japanese labelling content (within the approved scope)
  • Post-market surveillance programme
  • Customer relationships in Japan (as the legally responsible entity)

Practical contractual arrangements​

The Quality Agreement (品質契約) between the MAH and manufacturer must address:

  • How the manufacturer notifies the MAH of product changes (with lead time before implementation)
  • How adverse event information flows from the manufacturer to the MAH
  • How quality complaints received by the MAH are investigated by the manufacturer
  • How PMDA inspection requests for the manufacturing site are handled
  • What manufacturing data the MAH can access for regulatory purposes (batch records, QMS records)

Risk allocation​

The overseas manufacturer and the Kannin MAH share regulatory risk in Japan. The MAH bears the direct legal risk before MHLW. The contract governs how liability and indemnification flow between the parties when a regulatory problem occurs.