Overview — What is Shonin?
Shonin (承認) is Japan's pre-market approval pathway for Class III and IV devices, and for Class II devices without an applicable recognised standard. The formal approval decision is issued by MHLW following scientific review by PMDA. This two-agency structure — where one body reviews and another formally decides — has no direct parallel in EU, US, or Australian systems.
What Shonin authorises
A Shonin approval authorises a specific Japan-domiciled MAH to place a specifically described medical device on the Japanese market. The approval specifies:
- The MAH name and address
- The device name and model(s)
- The approved intended use
- The manufacturing site(s)
- Any conditions on the approval (e.g. post-market study requirements)
- The approval number (承認番号 — shonin bangō)
The approval number is publicly listed in PMDA's approval database.
Which devices require Shonin
- All Class IV devices (no exception)
- All Class III devices not covered by an MHLW-recognised standard (most Class III)
- Class II devices where no applicable recognised standard exists
- Class II devices where the MAH chooses not to pursue Ninsho (less common)
The Shonin holder — MAH obligations
The MAH that holds the Shonin:
- Is legally responsible for the device's safety and performance throughout its market life
- Must report adverse events to MHLW within statutory timelines
- Must collect post-market use-results data and submit a re-examination application
- Must file Ichibu Henko applications for significant device changes
- Must notify MHLW before withdrawing the device from the market
Shonin approvals do not expire — they remain valid until withdrawn by the MAH, revoked by MHLW, or lapsed due to non-renewal of the MAH's business licence.
Shonin vs Ninsho — key differences
| Feature | Shonin | Ninsho |
|---|---|---|
| Reviewing body | PMDA (review) + MHLW (decision) | Registered Certification Body (RCB) |
| Devices eligible | Class III/IV; Class II without recognised standard | Class II with recognised standard; some Class III |
| Typical timeline | 12–18+ months (standard); 6–9 months (priority) | 3–9 months |
| Re-examination requirement | Yes — typically 3–7 years | No re-examination period |
| Clinical evidence | Full package usually required | Standard conformity may suffice |
| Cost | Higher (PMDA review fees + application fees) | Lower (RCB fees only) |