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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 (check licence status on MHLW public database)? What is the Responsible Technical Officer's education, training, and experience in medical device regulation? Does the company have documented experience managing approvals for the same or similar device types or therapeutic areas?

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