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Appointing a Japan-Based MAH

Due diligence checklist​

When selecting a Japan-based Kannin MAH, assess:

Regulatory credentials:

  • Does the company hold a valid MAH licence for the relevant device class?
  • What is the Responsible Technical Officer's experience and qualification?
  • Does the company have experience with the specific device type or therapeutic area?

Operational capability:

  • Does the company have the capacity to manage the post-market obligations for your device?
  • What GPSP infrastructure does the company have (survey management, data collection)?
  • How does the company manage adverse event reporting?
  • What languages does the company work in? Can they work in English with your team?

Financial stability:

  • How financially stable is the company? MAH licence lapsing due to the Kannin's financial failure is a risk
  • What insurance does the company carry?

Contractual terms:

  • What are the transition terms if the relationship ends?
  • Who controls the dossier and approval documents?

References:

  • Can the company provide references from other overseas manufacturer clients?

Key contract provisions​

A well-drafted Kannin MAH agreement must specify:

  • Information sharing obligations (timelines for manufacturer to notify MAH of adverse events, changes, and overseas regulatory actions)
  • Responsibility allocation for each PMD Act obligation
  • Data ownership — especially rights to the approval dossier
  • Approval transfer obligations on termination (both parties must cooperate in the transfer process)
  • Indemnification provisions
  • Term, renewal, and termination triggers