Prefectural vs MHLW Licensing Authority
Licensing authority for MAHs and manufacturers in Japan is split between MHLW (national level) and prefectural governments (local level). Which authority issues a given licence depends on the device class and the nature of the activity. This split is unique to Japan's administrative structure.
Which authority issues which licencesβ
| Licence type | Issuing authority |
|---|---|
| General MAH licence (Class I, II, most Class III devices) | Prefectural government where MAH office is located |
| MAH licence for Class IV / specially designated Class III devices | MHLW |
| Domestic manufacturing licence β general | Prefectural government where facility is located |
| Domestic manufacturing licence β specially designated Class III/IV | MHLW |
| Class I Todokede notification | Prefectural government where MAH office is located |
Practical implicationsβ
For most medical device companies in Japan:
- The prefectural government of Tokyo is the issuing and oversight authority, since most MAHs and device companies are headquartered in Tokyo
- Interactions with MHLW directly (rather than through the Tokyo Metropolitan Government) occur for higher-risk device licences and for formal approvals/certifications
Understanding which authority to contact for a specific licence, change, or notification requires knowing both the device class and the MAH's office location.
Tokyo Metropolitan Government Health and Welfare Bureauβ
The Tokyo Metropolitan Government Health and Welfare Bureau (ζ±δΊ¬ι½η¦η₯δΏε₯ε± β now reorganised under Tokyo Metropolitan Government restructuring) is the most frequently encountered prefectural licensing authority in the medical device industry, given Tokyo's concentration of MAHs and device manufacturers. Their processes and timelines are broadly similar to other prefectures but may have Tokyo-specific administrative practices.
In addition to MAH licences, Japan also requires separate manufacturing licences for domestic manufacturing facilities. General domestic manufacturing licences are issued by the prefectural government where the facility is located. Manufacturing licences for specially designated Class III and all Class IV devices are issued by MHLW.