JP
Risk tiers on GHTF principles, but reached the way the United States reaches them: by matching the device to a generic name in a nomenclature.
Japan sits with the United States on the far side of the structural divide. The risk tiers under the Pharmaceuticals and Medical Devices Act follow GHTF principles and will look familiar, but you do not arrive at them by applying rules. The device is matched to a generic name in the JMDN nomenclature, and that name carries the classification. What follows from the class is a three-way split in the route to market: notification for the lowest tier, certification by a registered body for the middle, and approval by the authority for the highest. As in the United States, the shared questionnaire cannot answer this market — the work is the match, not the cascade.
Classes I to IV, described as general, controlled and highly controlled devices. The numerals resemble the European ones and mean something different, and because the class is inherited from a nomenclature entry rather than derived from the device's properties, there is no calculation to compare against the EU result.
| CLASS | RISK | INDEPENDENT REVIEW |
|---|---|---|
| I | General | Notification (Todokede) |
| II | Controlled | Certification by a registered body (Ninsho) |
| III | Highly controlled | Approval (Shonin), some certification |
| IV | Highly controlled | Approval (Shonin) |
By matching it to a generic name in the JMDN nomenclature, which carries the classification. Like the United States, Japan uses a lookup rather than a rule cascade.
The route to market: notification for the lowest tier, certification by a registered certification body for the middle tier, and approval by the authority for the highest.
There is no engine for this market yet. Tick it in the questionnaire anyway — it is counted, and we build in the order people ask.
