Overview — What is Ninsho?

JP-unique

Ninsho (認証) is Japan's pre-market certification pathway for Class II devices (and some Class III devices) that fall within the scope of an MHLW-designated recognised standard. Unlike Shonin (where PMDA reviews and MHLW decides), Ninsho is issued entirely by a Registered Certification Body (RCB) — a private third-party organisation accredited by MHLW.

What Ninsho authorises

A Ninsho certificate authorises the Japan-domiciled MAH to place the certified device on the Japanese market. The certificate specifies the device, the applicable recognised standard, the MAH, and the manufacturing site. The RCB maintains a register of its certifications.

Ninsho certificates do not expire in the same way as EU CE certificates — they remain valid as long as the RCB's ongoing surveillance confirms continued conformity and the MAH's business licence is current. However, the RCB conducts periodic surveillance audits.

Which devices are eligible for Ninsho

• Class II devices for which an applicable MHLW-recognised standard exists — the most common case
• Some Class III devices specifically designated by MHLW as Ninsho-eligible (listed in MHLW Cabinet Order)

If a device does not fall within the scope of any recognised standard, Ninsho is not available regardless of class.

The Ninsho holder — MAH obligations

The MAH that holds a Ninsho certificate has the same core post-market obligations as a Shonin holder — adverse event reporting, recall management, labelling compliance — but does not have a re-examination period requirement. Post-market surveillance is still required under GPSP, but the re-examination data submission process that applies to Shonin devices does not apply to Ninsho devices.

Ninsho vs Shonin — when to use which

Scenario	Pathway
Class II device with an applicable recognised standard	Ninsho (preferred — faster and lower cost)
Class II device with no recognised standard	Shonin (required)
Class II device with features outside standard scope	Shonin (required)
Class III device on MHLW's Ninsho-eligible list	Ninsho (optional)
Class III device not on MHLW's list	Shonin (required)
Class IV device	Shonin only (always)