The 2025 PMD Act Amendment (Act No. 37 of 2025): Key Changes

1. Key takeaways

Act No. 37 of 2025 (Reiwa 7), promulgated May 21, 2025, is the largest amendment to the PMD Act in roughly a decade. For medical device companies its impact concentrates in three areas: the codification of conditional approval, the strengthening of governance and supply responsibility, and the clarification of the duty to publish information on priority review. Enforcement proceeds in stages, beginning November 20, 2025, with May 1, 2026 as the principal enforcement date, and the governance and supply responsibility provisions in full force by May 2027. Because the provisions arrive at different dates, different parts of the compliance program mature at different times, and the remediation plan must be sequenced accordingly. A single amendment-wide remediation project would waste the window that the staged design deliberately provides.

• Act No. 37 of 2025 was promulgated on May 21, 2025 and is enforced in stages.
• Conditional approval is codified in the new Article 23-2-6-2.
• Governance and supply responsibility provisions are fully enforced by May 2027.
• Item numbers were rearranged, so citations must be re-confirmed on e-Gov. The staged design also means an obligation that is not yet enforced should already appear in the compliance plan, since the enforcement dates are fixed and known.

2. Legal basis

The amendment and its supporting instruments are cited below in the same terms as the source guidance. Because the amendment rearranged multiple provisions, every article and item number must be verified against the current text on e-Gov before it is quoted in any document.

1. Act Partially Amending the Acts Related to Assurance of Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc., Act No. 37 of 2025 (Reiwa 7), promulgated May 21, 2025.
2. New PMD Act Article 23-2-6-2 (conditional approval): For items with high medical necessity, such as those for rare diseases, pioneering products and specific-use products, approval is granted subject to conditions including the conduct of studies, where efficacy or performance can reasonably be predicted. This converts what was previously a notification-based practice into a statutory route with defined subjects and defined conditions.
3. Amendment of PMD Act Article 23-2-5: new publication requirements when approval is granted after a priority review; the related item numbers were rearranged accordingly.
4. Amendment of PMD Act Article 23-2-8 (special approval): the constitutive requirements are adjusted for products identical to an approved item and already approved in cabinet-order-designated foreign countries, and for situations where demand for an approved item is significantly unmet.
5. Governance and supply: a new order to replace the responsible officer; statutory codification of the appointment of quality assurance officers and related posts; establishment of a supply-system management officer; a notification duty upon shipment suspension; and a duty to maintain a stable supply system.
6. Supporting ordinance: MHLW Ordinance No. 117 of 2025 (Reiwa 7); the amendment of the Implementing Rules was promulgated on November 28, 2025 (for the provisions enforced from May 1, 2026).
7. Current legal framework: Act No. 145 of 1960.

3. Expert insights

Insight 1: the legislative drivers were governance failure and supply shortfall. The background of the amendment is summarized in two points: in successive misconduct incidents at pharmaceutical and device companies, management lacked the grasp and corrective capacity over on-site violations, exposing governance as hollow; and shortages centered on generics became chronic, while responses to shipment suspensions and similar events long depended on companies’ voluntary cooperation, leaving the state without the legal authority to grasp supply and demand quickly and accurately. Understanding the drivers allows the enforcement priorities to be anticipated. Both drivers point in the same administrative direction: requirements that previously lived in practice or ordinance now sit in the act itself, with enforcement powers behind them, and inspections can be expected to test precisely those requirements that the two failures exposed.

Insight 2: conditional approval writes early approval with post-market verification into the law itself. Article 23-2-6-2 gives genuine statutory form to the conditional early approval previously operated through notifications, and expands the eligible subjects. For Chinese innovative devices this constitutes a substantive addition to the available pathways. The route matters most where the evidence package at application is inherently incomplete, as is typical for innovative devices addressing unmet medical needs.

Insight 3: staged enforcement leaves a preparation window for compliance. Enforcement begins on November 20, 2025, reaches its principal milestone on May 1, 2026, and completes by May 2027, giving companies a phased preparation window. GRZAN recommends planning remediation backward from each milestone rather than waiting to remediate everything at once after full enforcement. Each milestone should trigger a defined package of internal work: a provision comparison at the start of enforcement, a pathway and workflow update at the principal date, and a final gap closure before full enforcement.

4. Practical recommendations

• Plan remediation backward from the three enforcement milestones. November 20, 2025; May 1, 2026; May 2027.
• Reassess the pathway combinations for innovative devices. Evaluate conditional approval alongside pioneering designation and priority review.
• Remediate the governance structure of the license holder early. Implement the responsible officer, the quality assurance officer and the supply-system management officer one by one.
• Check item numbers when citing provisions. The amendment rearranged many provisions; confirm against the current text on e-Gov before citing.

5. Verification checklist

• □ Is the promulgation date of the act confirmed as May 21, 2025?
• □ Has remediation been planned backward across the three milestones of November 20, 2025 / May 1, 2026 / May 2027?
• □ Has conditional approval (Article 23-2-6-2) been included in the pathway assessment for innovative devices?
• □ Have the three governance posts (responsible officer, quality assurance officer, supply-system management officer) each been implemented?
• □ Are item numbers checked against the current text on e-Gov when citing provisions?

Regulatory information verified as of October 29, 2026.

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 adverse event reporting and recall coordination with PMDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com