Governance and Supply Responsibility Under the 2025 Amendment

1. Key takeaways

Act No. 37 of 2025 (Reiwa 7) writes management-level responsibility and supply responsibility into the PMD Act: it creates a new order to replace the responsible officer, elevates posts such as the quality assurance officer to statutory status, requires the establishment of a supply-system management officer, and codifies a notification duty upon shipment suspension together with a duty to maintain a stable supply system. The relevant provisions enter into full force within two years of promulgation, that is, by May 2027. For Chinese manufacturers this directly narrows the viability of the nominee-license-holder model. The design intent is visible in the instruments themselves: each new duty attaches either to a named individual within the MAH or to a defined supply event, so that both persons and processes fall within the reach of the regulator. A license arrangement that separates the license from the real decision-makers survives this structure far less well than one where the holder genuinely governs.

• A new administrative order can compel replacement of the responsible officer.
• Quality assurance officer and related posts are now statutory, not merely ordinance-level.
• Shipment-suspension notification and stable-supply obligations are codified. Full enforcement of these provisions comes by May 2027, which leaves a defined but finite period to restructure before the duties bite.

2. Legal basis

The governance and supply provisions stem from the same amendment act and its supporting ordinance. The items below reproduce the source guidance in the same terms and should be verified against the current text on e-Gov before any citation is used. Together they shift the compliance center of gravity from documents to people and to the observable state of the supply chain.

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. Creation of the order to replace the responsible officer: where a quality-related problem arises, the Ministry of Health, Labour and Welfare may require the MAH to replace its responsible officer.
3. Statutory codification of the appointment of the quality assurance officer and related posts: duties previously demanded mainly at ordinance level are elevated to the level of the act.
4. Establishment of the supply-system management officer, the notification duty upon shipment suspension, and the codified duty to maintain a stable supply system. Each of these elements gives the regulator a concrete point of contact for supply failures, rather than relying on voluntary cooperation after the event.
5. Supporting ordinance: MHLW Ordinance No. 117 of 2025 (Reiwa 7).
6. Enforcement rhythm: staged enforcement from November 20, 2025, with the governance and supply responsibility provisions in full force by May 2027.
7. Current legal framework: Act No. 145 of 1960.

3. Expert insights

Insight 1: the order to replace the responsible officer points administrative measures at individuals. Administrative dispositions against violative companies have traditionally targeted the legal entity, through business suspension orders and the like. The replacement order enables the authorities to require the removal of a specific member of management. This changes the compliance incentive structure: individual members of the executive now bear the direct consequences of compliance performance. For a foreign manufacturer, the practical consequence is that the quality of its D-MAH’s management team becomes a regulatory variable, not merely a commercial one. Choosing a holder solely on price or convenience carries a governance risk that this provision makes explicit.

Insight 2: statutory codification of posts means staffing becomes a verifiable item. Once the quality assurance officer, safety management officer and similar posts are elevated from ordinance-level requirements to the level of the act, whether the posts are filled becomes a direct object of legal conformity judgment, rather than one scored item within a system evaluation. Verification also becomes simpler for the regulator: an unfilled statutory post is observable directly, without the interpretive work that a graded system evaluation requires. For the company, this elevates appointment records, job descriptions and the actual authority of these posts into first-rank compliance evidence.

Insight 3: supply responsibility imposes requirements on the supply chain structure of Chinese manufacturers. The duty to maintain a stable supply system and the shipment-suspension notification duty demand the capability to grasp upstream supply conditions. An architecture that depends on a single overseas factory with no alternative capacity will appear fragile along this dimension. A structured monitor over upstream capacity, critical materials and single points of failure produces the evidence of a maintained stable supply system that the codified duty presupposes, and turns what would otherwise be a crisis response into a reportable, routine state.

4. Practical recommendations

• Complete governance gap remediation before May 2027. Advance along three lines: responsible officer, statutory posts and supply management, with each line carrying its own evidence package and its own owner.
• Reassess the governance maturity of the existing D-MAH. Look beyond the license categories held, to whether the organization can bear the strengthened responsibility structure, including whether its responsible officer can realistically perform the role the act now contemplates.
• Build internal monitoring of supply risk. Upstream capacity, critical materials and single points of failure should each produce a reportable status.
• Link the shipment-suspension and supply-shortage reporting workflows to the Japanese license holder. Define trigger conditions, reporting deadlines and responsible persons, so that the Japanese and overseas halves of the same supply event produce one coherent report rather than two disconnected ones.

5. Verification checklist

• □ Has a gap analysis been completed along the three lines of responsible officer, statutory posts and supply management?
• □ Has the governance maturity of the existing D-MAH been reassessed?
• □ Is supply-risk monitoring (capacity, critical materials, single points of failure) in place?
• □ Are the shipment-suspension and supply-shortage reporting workflows linked with the license holder?
• □ Is the full-enforcement milestone of May 2027 included in the remediation schedule?

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