Designated Controlled Devices: Certification Scope Decided by MHLW Designation

1. Key takeaways

The scope of third-party certification is decided by the designation of the Minister of Health, Labour and Welfare, not automatically by risk class. Only designated controlled medical devices and designated highly controlled medical devices can use certification; items not designated fall back to Shonin (approval) without exception. GRZAN requires that whether an item is designated be treated as a question of fact supported by official evidence, not a matter of experienced judgment.

• Article 42(2) of the PMD Act empowers the Minister to set certification standards for designated medical devices.
• Article 23-2-13 requires designated items to be certified by a Registered Certification Body.
• Article 41(3) sets the essential requirements, which apply to both certification and approval.
• Article 23-2-5(1) requires non-designated items to obtain approval.
• Article 2(6) and (7) define controlled and highly controlled medical devices and vest the designation power in the Minister.
• GRZAN’s assessment: the designation question has three evidentiary layers, and skipping any one of them risks a return after submission.
• The practical corollary is that the pathway decision should be dated and sourced: designation status, RCB coverage and standard versions all move over time, so an undated pathway memo cannot be defended at review.

The consequence for project planning is direct: certification feasibility is a snapshot, and the snapshot must be retaken whenever the filing date moves. A route chosen from a year-old check cannot be assumed to survive to submission.

2. Legal basis

Certification standards for designated devices. Under Article 42(2) of the PMD Act, the Minister of Health, Labour and Welfare establishes certification standards for designated medical devices. The designation and the standard are the twin conditions of the certification route.

RCB certification. Article 23-2-13 requires that designated items be certified by a Registered Certification Body registered with the Minister. Certification outside the designated scope has no legal basis.

Essential requirements. Article 41(3) provides the basic requirements for medical devices. These apply jointly to the certification route and the approval route, so the essential-requirements file is needed either way.

Approval for the rest. Under Article 23-2-5(1), items that are not designated must obtain approval. Japan provides no case-by-case channel to argue for certification of a non-designated item.

Classification definitions. Article 2(6) and Article 2(7) of the PMD Act define controlled medical devices and highly controlled medical devices respectively, with the designation power held by the Minister.

Current legal corpus. Act No. 84 of 2013, promulgated on 27 November 2013 and effective on 25 November 2014, extended third-party certification to designated highly controlled medical devices; the underlying corpus remains Act No. 145 of 1960.

3. Expert insights

Designation is a separate administrative act, distinct from classification. Classification under Article 2(6) and (7) determines whether a product is controlled or highly controlled; designation under Article 42(2) and Article 23-2-13 determines whether it can be certified. Both acts are made by the Minister of Health, Labour and Welfare, but they are not synchronized: within the same class, some generic names are designated and others are not. A Chinese manufacturer that reasons from risk class to certification route commits a category error that the statute itself does not permit. GRZAN recommends building the pathway decision on the designation status of the specific generic name, evidenced from official listings.

The 2014 extension covered highly controlled devices, not all Class III. Act No. 84 of 2013 extended third-party certification from controlled medical devices to highly controlled medical devices, using the mechanism of setting standards and making designations. Class III items that can be certified do exist, but certifiability still depends on designation. Reading the 2014 extension as meaning that Class III is certifiable across the board is an incorrect inference. The correct reading is narrow: the extension enlarged the pool of potentially designated items, and each item must still be checked against current designations.

Official verification has three layers. First, check whether the generic name has a certification standard, using the MHLW public listings of certification standards. Second, check whether an RCB accepts the item, using each body’s published scope of certification. Third, check the current version and amendment status of the applicable standard. Missing any one layer can produce a return after submission. GRZAN treats the three checks as three separately archived pieces of evidence, because each answers a different objection: legal availability, practical availability and currency.

4. Practical recommendations

• Complete the three-layer verification and archive the evidence: existence of the standard, RCB coverage, and the current version of the standard.
• Where the item is not designated, prepare for approval immediately and do not wait. Japan has no routine channel to seek certification for an individual non-designated item.
• Monitor amendments to certification standards as part of the change-control watch, because revisions affect the maintenance obligations of already certified items.
• For borderline items, evaluate certification and approval side by side, comparing the dossier cost and schedule of both routes before fixing the submission strategy.
• Record the source and date of every designation check so the evidence remains re-verifiable at review.

5. Verification checklist

• □ Has the presence or absence of a certification standard for the generic name been confirmed through MHLW or PMDA public listings?
• □ Has current RCB coverage of this item been confirmed?
• □ Has the current version and latest amendment status of the applicable certification standard been confirmed?
• □ For non-designated items, has the dossier been prepared on the approval route?
• □ Are amendments to certification standards included in the company’s change-monitoring list?

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