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General MAH Licence (Ippan MAH)

Application process​

A general MAH licence application is filed with the prefectural government where the MAH's principal office is located. For most companies in Tokyo, this is the Tokyo Metropolitan Government Health and Welfare Bureau.

Required documentation:

  1. Application form (prescribed format, Japanese)
  2. Articles of incorporation of the applicant company
  3. Curriculum vitae and qualifications of the proposed Responsible Technical Officer
  4. Floor plan and description of the MAH's office facilities
  5. Description of the QMS to be maintained

Timelines​

The prefectural government review typically takes 1–3 months after submission of a complete application. Complex applications or requests for clarification by the prefecture can extend this timeline.

Responsible Technical Officer (RTO) requirements​

The RTO must hold qualifications specified in MHLW ordinances:

  • For devices: typically a degree in pharmacy, medicine, dentistry, veterinary science, or equivalent science/engineering discipline
  • Plus a minimum period of relevant practical experience (typically 3 years in a quality or regulatory role for medical devices)

The RTO does not have to be a Japanese national, but must be accessible in Japan.

Renewal — 5-year cycle​

MAH licences expire every 5 years and must be renewed. Renewal requires:

  • Evidence of continued QMS compliance
  • Confirmation of current Responsible Technical Officer
  • Payment of renewal fee

If the MAH licence lapses, all Shonin approvals and Ninsho certifications held by that MAH are invalidated — a significant commercial and regulatory risk. Set up reminders well in advance of the renewal date.