Ninsho Certification: RCB Conformity to Certification Standards for Mature Devices

1. Key takeaways

Certification (ninsho) is in essence confirmation by a private-sector body that a product conforms to standards already published by the Minister of Health, Labour and Welfare, which is why it is available only for mature items that already have certification standards. The correct judgment for Chinese manufacturers is procedural: first check whether a certification standard exists for the target generic name; if it exists, certify, and if not, seek Shonin (approval). Technical maturity of a product can never substitute for the existence of a standard.

• Article 41(3) of the PMD Act provides the essential requirements for medical devices set by the Minister.
• Article 42(2) empowers the Minister to set certification standards for designated devices.
• Article 23-2-13 requires designated items to be certified by a Registered Certification Body (RCB) registered with the Minister.
• Article 23-2-23(1) allows a foreign manufacturer to obtain certification through an appointed Japanese marketing authorization holder.
• Article 23-2-5(2) is the review-judgment provision for approval and serves as the contrast anchor for certification.
• GRZAN’s assessment: the single most valuable hour in this pathway is the one spent confirming that a certification standard exists and that an RCB currently covers the item.

2. Legal basis

Essential requirements. Under Article 41(3) of the PMD Act, the Minister of Health, Labour and Welfare establishes the basic requirements for the quality, efficacy and safety of medical devices. These essential requirements apply to both the certification route and the approval route.

Certification standards. Under Article 42(2), the Minister sets certification standards for designated medical devices. A product can be certified only against such a standard; where no standard exists, the certification route is legally unavailable regardless of the product’s maturity.

RCB certification. Article 23-2-13 provides that designated items must be certified by a Registered Certification Body registered with the Minister of Health, Labour and Welfare. The RCB judges conformity with the certification standard and with the essential requirements.

Foreign manufacturers. Under Article 23-2-23(1), a foreign manufacturer obtains certification through a Japanese marketing authorization holder it has appointed. The Japanese holder, not the foreign manufacturer, is the counterparty of the certification.

Contrast anchor. Article 23-2-5(2) sets the review-judgment requirements for approval, covering the applicant’s licence qualification, the registered manufacturing site, the manufacturing and quality management systems, and the judgment of quality, efficacy and safety. Certification performs only the last of these, and only against published standards.

Current legal corpus. Act No. 145 of 1960; Act No. 84 of 2013, promulgated on 27 November 2013, extended third-party certification to designated highly controlled medical devices.

Practical estimate: the number of active RCBs in Japan is around ten, and each body’s coverage differs markedly by item, so confirmation must be item-specific rather than category-level.

3. Expert insights

Certification judges conformity with a standard, not whether the product works. This is the watershed between certification and approval. On the approval route, PMDA judges quality, efficacy and safety under Article 23-2-5(2). On the certification route, the RCB judges conformity with the certification standard and the essential requirements. The judgment is narrower, the evidence burden is lighter, and this is precisely why certification timelines are typically shorter than approval. It also explains why a product with no standard cannot be forced onto this route: there is nothing to be conformant with. GRZAN treats the existence of a standard as a factual gate, not a strategic preference.

The RCB is a private body under double supervision. Registered Certification Bodies are registered by the Minister of Health, Labour and Welfare. PMDA conducts pre-registration review, registration renewal review and periodic on-site inspections of RCBs, and each RCB is obliged to report the grants and revocations of certifications to the ministry. Because of this supervision structure, an RCB’s scope of acceptance moves with its registration status and its own business adjustments. Before filing, the applicant must confirm with the specific RCB that it accepts the specific item and must check its current scheduling; assuming category-level coverage is a frequent and costly error.

Products clearly different from predicate items cannot be certified. Where a product differs markedly from existing items in shape, principle, method of use or performance, it cannot be evaluated against the certification standard and the application must fall back to approval. Innovation itself is a factor that pushes a product out of the certification route, not one that keeps it there. This is why GRZAN requires the sequence of checking the standard first and discussing the pathway second: the pathway discussion is meaningless until the standard question is answered with documentary evidence.

4. Practical recommendations

• Use the existence of a certification standard as the sole judgment criterion. Do not rely on industry experience such as claims that products of this type generally certify.
• Confirm the RCB’s scope of acceptance and current scheduling directly with the body. Coverage is registered item by item and may change (practical estimate: around ten active RCBs in Japan, with markedly different coverage).
• Submit the QMS conformity investigation on the certification route in parallel with the certification application. On this route the investigation is conducted by the RCB, and the two tracks advance in parallel.
• Keep material headroom for a fallback to approval. If the product is found not to fit a certification standard, the dossier must be rebuilt to approval requirements; organizing it to the higher standard from the start reduces switching cost.
• Record the standard check, the RCB coverage check and the version check as three separate pieces of evidence in the project file.

5. Verification checklist

• □ Has it been confirmed that a certification standard exists for the target generic name and that the item has been designated?
• □ Has the RCB’s coverage of this specific item been confirmed with the body, rather than inferred from the device category?
• □ Has the RCB’s QMS conformity investigation application been submitted in parallel?
• □ Have differences from predicate items in shape, principle, method of use and performance been assessed to predict any fallback-to-approval risk?
• □ Have materials and schedule headroom been reserved for the fallback-to-approval scenario?

Regulatory information verified as at 29 October 2026. Legal texts follow the current provisions published on e-Gov and the notices issued by MHLW and PMDA, and must be rechecked after amendment or repeal. Time limits and procedural details reflect the official position on that date; content marked practical estimate has no legal effect.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team manages PMDA premarket submissions and notification procedures, coordinates clinical evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com