Japan

The Ministry of Health, Labour and Welfare (MHLW) sets overall health policy and the regulatory framework, while the Pharmaceuticals and Medical Devices Agency (PMDA) handles marketing approvals, scientific review and QMS audits. For certain lower-risk device groups, Registered Certification Bodies (RCBs)carry out third-party conformity certification.

Yes. No device may be marketed without the appropriate authorisation. Higher-risk devices require marketing approval for each item from PMDA (PMD Act Art. 23-2-5(1)); designated lower-risk devices instead obtain certification from an RCB (Art. 23-2-23(1)); the lowest-risk devices require only a marketing notification to PMDA.

Japan uses a four-tier, risk-based scale (Class I to Class IV) mapped onto the PMD Act categories of general, controlled (Class II) and specially-controlled (Classes III–IV) medical devices. IVDs follow an aligned classification and, for the lowest class, a notification route, with certification or approval at higher classes.

You need someone local. Only a Marketing Authorisation Holder (MAH) resident in Japan, an individual or legal entity holding a marketing licence from the prefectural government, can hold the authorisation and take full responsibility for post-market activities. Japan operates a single-MAH-per-device model; the MAH cannot be a foreign entity, and the authorisation cannot be transferred or shared between MAHs. Foreign manufacturers must additionally obtain foreign manufacturer registration for each manufacturing facility exporting to Japan (Art. 23-2-4).

Japan requires a quality management system aligned with ISO 13485:2016, implemented domestically through MHLW Ministerial Ordinance No. 169 (the QMS Ordinance). A QMS conformity certificate is required for Class II–IV devices, registered manufacturing-site designation applies, and design & development controls apply to Classes II–IV. As an MDSAP market, Japan can accept an MDSAP audit report toward the QMS conformity assessment.

A marketing approval/certification remains effective for the approved device but is subject to ongoing obligations and periodic renewals of related registrations (for example, certain registrations renew on fixed multi-year cycles under the PMD Act). When a device changes, the route depends on significance: a partial-change application (审查/re-review) is required for significant changes affecting safety, efficacy or specifications, while minor changes are handled by notification.

Japanese-language labelling is mandatory. The MAH name and address must appear on the label, instructions for use must be provided in Japanese, and patient implant cards are required for applicable implantable devices (Essential Principle 13A). Technical documentation submitted to PMDA is generally expected in Japanese.