MAH and Business Licences
The Marketing Authorization Holder (MAH) system is the cornerstone of Japan's medical device regulatory framework. Every device approval or certification must be held by a Japan-domiciled MAH — the single most important structural difference between Japan and all other major markets.
Why the MAH system matters
For overseas manufacturers, the MAH requirement is the single most consequential feature of Japan's regulatory framework. It means:
- You cannot obtain a Japanese device approval directly — a Japan-domiciled entity must hold it on your behalf
- Your Japan regulatory obligations are primarily executed by your MAH — adverse event reports, recall notifications, and change applications all go through the MAH
- Your commercial relationship with your MAH is also a regulatory relationship — the quality agreement and commercial contract must both be carefully structured
Pages in this section
| Page | What it covers |
|---|---|
| What is an MAH? | Definition, legal basis, the Japan domicile requirement |
| MAH Licence Types | General MAH licence, staffing requirements, issuing authority |
| Eligibility and Domicile | What "Japan domicile" means; options for overseas manufacturers |
| General MAH Licence | Application process, RTO requirements, 5-year renewal |
| Licensed MAH (Kannin) | Third-party MAH model; contractual obligations; transition risks |
| MAH Responsibilities | Full list of PMD Act obligations; personal liability of responsible officers |
| Appointing a Japan-Based MAH | Due diligence checklist; key contract provisions |
| Foreign Manufacturer Registration | FMR process; annual confirmation; QMS inspection obligations |
| Contracted QMS Operations | Outsourcing manufacturing; MAH oversight obligations |
| MAH Licence Renewal | 5-year cycle; consequences of lapsing |
| Change Notifications | Changes requiring MAH licence amendment or notification |
| Licence Surrender and Transfer | Changing MAHs; transferring approvals; voluntary withdrawal |
| MAH vs Manufacturer | Split responsibilities; quality agreement essentials |
| Prefectural vs MHLW Authority | Which body issues which licence |