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 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).
Shonin MAH (the entity holding a specific Shonin approval for Class III or IV devices): Higher QMS and staffing requirements apply when the MAH holds approvals for high-risk devices.
Staffing requirements
To hold an MAH licence, the entity must designate a Responsible Technical Officer (総括製造販売責任者 — Sokatsu Seizouhanbaigyo Sekininsha). This individual:
- Must meet education and experience requirements specified in MHLW ordinances (typically a pharmaceutical or scientific degree plus relevant experience)
- Is personally responsible for QMS compliance
- Must be accessible to MHLW and PMDA
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 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) |