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类别: REGULATORY PATHWAYS
认证(日本第三方认证)
适用于符合已发布认证标准（认证基准）的日本II类器械的监管途径。审查由注册认证机构（RCB）而非PMDA进行。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.
WHEN IT APPLIES
Ninsho is third-party certification in Japan for many Class II devices that conform to published certification standards (Ninsho Kijun), reviewed by an RCB rather than full PMDA Shonin review.
PROCESS / STEPS
- Verify a certification standard exists for the device.
- Select a Registered Certification Body.
- Submit certification package and close findings.
- Maintain post-certification change control with the DMAL.
EXAMPLES
- Certain controlled Class II devices with clear standards use Ninsho for faster market access than Shonin.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to 认证(日本第三方认证) across 27 authorities in real time.
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