MAH Licence Types and Requirements
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 categoriesβ
General MAH licence (δΈθ¬θ²©ε£²ζ₯θ β 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 requirementsβ
Staffing requirements β To hold an MAH licence, the entity must designate at least one Responsible Technical Officer. For higher-risk device categories (Class IV and specially designated Class III), additional qualified personnel may be required; confirm with the licensing authority.
Quality system requirements for the MAHβ
The MAH itself (not just the manufacturer) must maintain a quality system covering:
- Contracts with manufacturers β defining responsibilities under MO 169
- Post-market surveillance system β GPSP compliance
- Adverse event reporting system
- Change management system β evaluating changes for Ichibu Henko requirements
Licence issuance authorityβ
| Device type | Issuing authority |
|---|---|
| General medical devices (Class I, II, most Class III) | Prefectural government where MAH office is located |
| Class IV / specially designated Class III | MHLW (national level) |