MHLW notice continuing the pilot of prioritized review for software as a medical device (SaMD), conducted since FY2022 following a June 2022 Cabinet decision on the New Capitalism action plan, by setting designation requirements and accepting applications on a rolling basis. Eligible products are SaMD and physical medical devices with SaMD-equivalent program functions; products seeking approval under the rebalancing notice or the two-stage approval notice are excluded. All three requirements must be met: (1) innovativeness of the treatment, diagnostic or preventive method (programs that deliver content equivalent to clinical patient guidance to prompt behavior change at home are, in principle, not considered innovative); (2) medical usefulness for the target disease; and (3) intent and capability to file in Japan first or simultaneously (within three months), using the PMDA SAKIGAKE comprehensive evaluation consultation. Designated products receive priority consultation, priority review under Article 23-2-5, paragraph 10 of the PMD Act, coordination by a concierge, and eligibility for the support program for consultation and applications for innovative medical devices, with the aim of shortening the review period to six months or less after adequate pre-submission evaluation. The procedure runs from registration, hearing and preliminary screening to formal application and PMDA evaluation, with results reported to the Pharmaceutical Affairs Council and then published. Conditions for revoking designation are also specified.

Q&A (Part 3) issued by the Japanese Ministry of Health, Labour and Welfare (MHLW), clarifying when manufacturing/marketing and sales activities are deemed to begin for home-use medical device software (SaMD) distributed via app stores or download servers. Manufacturing/marketing is deemed to start when the software is made available on a download server or app store, while sales is deemed to start when the end user is able to use it. Issued 25 March 2026 in response to a growing number of approved home-use device programs. It also confirms that a company acting as both marketing authorization holder and seller needs both business licenses (or notifications), and that legally required labeling information may be provided via easily accessible electronic records rather than a printed insert, provided it is given to the user before use.

Notice (MHLW-PFSB-MDED-0306-No.1, 6 March 2026) issued by the Medical Device Evaluation Division setting out procedures for the registration and operation of Registered Conformity Assessment Bodies (RCABs) for medical devices and in vitro diagnostics in Japan. It principally implements a new succession-of-status scheme introduced by the 2025 amendment to the PMD Act (Act No. 37 of 2025), covering business transfers, inheritance, mergers, and demergers of RCABs. The notice also covers registration application procedures and the registration license tax (JPY 90,000), notification requirements for suspension or discontinuation of business (at least two weeks before the planned date), operating rules aligned with ISO/IEC 17021-1 and 17065, restrictions on consulting activities that could compromise confidentiality or impartiality, and detailed succession procedures beginning with prior consultation six months in advance. The notice takes effect on 1 May 2026.