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MAH Licence Renewal (5-year cycle)

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MAH licences in Japan expire every 5 years and must be actively renewed. Unlike some regulatory jurisdictions where licences automatically continue until revoked, Japan's MAH licence lapses if not renewed — and with it, all Shonin approvals and Ninsho certifications held by the MAH.

The 5-year renewal cycle​

MAH business licences expire on the anniversary of the original licence date, every 5 years. The renewal application must be submitted to the licensing authority (prefectural government or MHLW) before the expiry date.

Renewal requirements​

The renewal application requires:

  • Application form (prescribed format)
  • Updated Responsible Technical Officer information
  • Confirmation of QMS maintenance
  • Updated facility description if any changes have been made
  • Renewal fee payment

The licensing authority may conduct an inspection or desk review as part of the renewal process.

Consequences of lapsing​

If the MAH licence lapses — even briefly — the legal effect is serious:

  • All Shonin approvals held by the MAH are invalidated
  • All Ninsho certifications held by the MAH are invalidated
  • The device cannot legally be sold in Japan
  • Restoring market access requires re-application and re-approval — a lengthy process

This is not a theoretical risk. MAH licence lapses have occurred, typically due to administrative oversight or corporate changes. Put renewal date reminders in place at least 6 months in advance.

Practical renewal timeline​

  • 12 months before expiry: Confirm renewal date and begin internal preparation
  • 6 months before expiry: Prepare renewal documents and confirm RTO status
  • 3 months before expiry: Submit renewal application
  • Before expiry: Confirm receipt and processing by the prefectural government or MHLW