Approval vs Certification vs Notification

JP-unique

Japan's three-pathway system — Shonin (承認), Ninsho (認証), and Todokede (届出) — maps loosely to device risk class but has its own logic that differs from all other major markets. The key differentiator between Shonin and Ninsho is not just class, but whether an applicable MHLW-recognised standard exists for the device type.

Quick reference

Pathway	Term	Applies to	Reviewed by	Typical timeline
Approval	Shonin (承認)	Class III, IV; Class II without recognised standard	PMDA → MHLW	12–18+ months
Certification	Ninsho (認証)	Class II (with recognised standard); some Class III	Registered Certification Body (RCB)	3–9 months
Notification	Todokede (届出)	Class I	Prefectural government	Days–weeks

Approval — Shonin

Shonin is Japan's full pre-market approval pathway. It is required for:

• All Class IV devices (highest risk — e.g. implantable cardiac devices, HIV IVDs)
• All Class III devices that do not fall within a recognised standard category
• Class II devices where no applicable recognised standard exists

The Shonin process involves submitting a full application dossier to PMDA, which conducts a scientific review and produces a review report. MHLW then issues the formal approval decision. The MAH receives a Shonin approval number.

Shonin approvals can have conditions attached — most commonly a requirement to conduct post-market studies or report certain outcomes to MHLW.

Certification — Ninsho

Ninsho is available for devices that fall within the scope of an MHLW-designated recognised standard. It is typically used for:

• Class II devices with an applicable recognised standard (the most common scenario)
• Some Class III devices specifically designated by MHLW as eligible for Ninsho

Ninsho is faster and less costly than Shonin because it does not involve PMDA review. The MAH selects an accredited RCB, submits a technical dossier demonstrating conformity with the recognised standard, and the RCB issues the certification if satisfied.

If a device changes significantly and falls outside its recognised standard, the MAH must switch from Ninsho to Shonin.

Notification — Todokede

Todokede is the simplest pathway, available only for Class I (general) medical devices. The MAH files a notification with the prefectural government providing basic product information. There is no scientific review. The MAH may begin marketing once the notification is acknowledged.

Post-market obligations for Class I devices are lighter than for Class II–IV, but the MAH still bears responsibilities for adverse event reporting and labelling compliance.

How to determine which pathway applies

1. Classify the device — determine the JMDN code and class (I–IV)
2. Check the recognised standards list — does an MHLW-recognised standard exist for this device type?
   • If Class I → Todokede
   • If Class II and recognised standard exists → Ninsho
   • If Class II and no standard, or Class III/IV → Shonin
3. Confirm with PMDA if uncertain — a pre-submission consultation can confirm the pathway before significant resource is committed

Borderline situations (e.g. a Class II device where an RCB determines it does not conform to the available standard) require case-by-case evaluation.