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MAH Licence Types and Requirements

JP-unique

Japan distinguishes between MAH licence categories based on the types of devices the entity will market. The licence class determines the regulatory requirements the MAH must meet and which regulatory authority (prefectural government or MHLW) issues the licence.

MAH licence categories​

General MAH licence (一般販売業者 — ippan hanbai gyosha): The standard MAH licence for entities marketing medical devices. Issued by the prefectural government where the MAH's principal office is located (in most cases).

Class III/IV MAH licence (for entities marketing Class III or Class IV devices under Shonin approvals): Higher QMS and staffing requirements apply. Issued by MHLW at the national level.

Staffing requirements​

Staffing requirements ​ To hold an MAH licence, the entity must designate at least one Responsible Technical Officer (RTO). For higher-risk device categories (Class IV and specially designated Class III), additional qualified personnel may be required — typically at minimum a QA manager and a post-market surveillance coordinator. Confirm specific staffing requirements with the licensing authority (prefectural government for General MAH; MHLW for Class IV/specially designated Class III MAH).

Quality system requirements for the MAH​

The MAH itself (not just the manufacturer) must maintain a quality system covering:

  • Contracts with manufacturers — defining responsibilities under MO 169
  • Post-market surveillance system — GPSP compliance
  • Adverse event reporting system
  • Change management system — evaluating changes for Ichibu Henko requirements

Licence issuance authority​

Device typeIssuing authority
General medical devices (Class I, II, most Class III)Prefectural government where MAH office is located
Class IV / specially designated Class IIIMHLW (national level)

Note on terminology: The General MAH licence is also referred to as 'ippan hanbai gyosha' (一般販売業者, literally 'general sales business operator'), not to be confused with 'ippan MAH' (一般製造販売業許可) which uses different characters. MHLW documentation uses both terms; ensure consistency when filing applications.