Japan Three Key Officers: Sanyaku Roles of Marketing Authorisation Holders

1. Key takeaways

Every Japanese licensed entity must appoint three statutory officers: the general supervisor of manufacturing and marketing, the quality assurance supervisor, and the safety management supervisor. Collectively these positions are known as the three key officers, or sanyaku. They correspond respectively to overall responsibility, quality management, and post-market safety management. Act No. 37 of 2025 further strengthens the statutory footing of these positions and introduces a change order directed at responsible executive officers. GRZAN’s assessment is that once the 2025 amendment is fully in force, the nominee-holder model will be very difficult to sustain in Japan.

• The three key officers are a legally required structure for every Japanese licensed entity, covering overall duty, quality and post-market safety.
• The QMS ordinance for devices is MHLW Ordinance No. 169 of 2004, published on December 17, 2004; the GVP ordinance is MHLW Ordinance No. 170 of 2004.
• Act No. 37 of 2025, published on May 21, 2025, newly establishes the responsible executive officer change order and makes the quality assurance supervisor position statutory.
• The amendment takes effect in stages from November 20, 2025, with governance and supply responsibility provisions fully in force within two years of publication, that is by May 2027.
• After full implementation, accountability can reach named executives and specific responsible positions, not only the corporate entity.
• Nominee-style holding arrangements that rely on the licensed entity as a passive nameplate will not survive the amended governance regime.
• The supply system management supervisor is a newly introduced dimension, together with shipment-suspension notification and stable supply obligations.

2. Legal basis

Article 23-2, paragraph 1 of the PMD Act includes organisational and staffing requirements among the conditions for the manufacturing and marketing business licence. This is the anchoring provision for the three key officers: the licensed entity must be organised so that each statutory duty has a designated person behind it.

The GQP-related ordinance for medical devices, quasi-drugs, cosmetics and regenerative medicine products sets the quality management standards. For the device portion, the relevant standard is the QMS ordinance, MHLW Ordinance No. 169 of 2004, published on December 17, 2004. The GVP-related ordinance, the ordinance on standards for post-marketing safety management of medical devices, is MHLW Ordinance No. 170 of 2004, and it defines the duties of the safety management supervisor.

The partial amendment of the Act and related legislation on ensuring the quality, efficacy and safety of pharmaceuticals, medical devices and other products is Act No. 37 of 2025, published on May 21, 2025. It contains the new responsible executive officer change order and the statutory establishment of the quality assurance supervisor and related positions.

On timing, Act No. 37 of 2025 takes effect in stages from November 20, 2025, and the provisions on governance and supply responsibility are to be fully implemented within two years of publication, that is by May 2027. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: the three key officers are a separation-of-duties design, not three names on a form. The general supervisor carries overall responsibility, the quality assurance supervisor manages quality, and the safety management supervisor manages post-market safety. The legal duties and the ordinance standards for the three positions are set separately, and the design intent is that quality and safety each have an accountable owner. A practice sometimes seen among overseas manufacturers is to have one person hold multiple positions. This weakens the verifiability of the system, because the checks and balances that the statutory design assumes between the roles disappear when the roles collapse into a single individual.

Insight 2: the 2025 amendment pushes accountability from the corporate level up to management. Act No. 37 of 2025 newly establishes the responsible executive officer change order and makes the quality assurance supervisor and related positions statutory. The practical meaning is that when a quality event occurs, administrative measures can be directed at specific members of management and at specific responsible positions, not only at the legal entity itself. Compliance planning that treats the licensed entity as an anonymous shell therefore stops working under the amended regime.

Insight 3: the supply system management supervisor is a new dimension. The same amendment introduces the supply system management supervisor together with the obligation to notify shipment suspensions and the obligation to maintain a stable supply system. For overseas manufacturers that depend on a single overseas factory, this dimension feeds directly into the organisational requirements imposed on the licensed entity, and it should be factored into how the D-MAH relationship is structured and resourced.

4. Practical recommendations

• Ensure the licensed entity can produce written appointments and duty statements for all three key officers, with the boundaries between the three roles set out clearly in the organisational rules.
• Prepare in advance for full implementation by May 2027, and include the responsible executive officer change order and the statutory position requirements in the compliance gap analysis.
• Re-assess the governance capability of the existing D-MAH, looking not only at the licence class but also at whether its organisation can meet the strengthened governance requirements.
• Build an internal mechanism for supply responsibility, so that reporting flows for shipment suspension and supply shortfall are designed jointly with the Japanese licensed entity.
• Track the staged entry into force of Act No. 37 of 2025 so that each governance obligation is addressed before its effective date.

5. Verification checklist

• □ Has the licensed entity appointed the three key officers and issued written appointments and duty statements?
• □ Has the gap analysis against Act No. 37 of 2025, published on May 21, 2025, been completed for the governance requirements?
• □ Has the May 2027 full-implementation milestone been entered in the compliance calendar?
• □ Has the organisational capability of the existing D-MAH been re-assessed against the strengthened governance requirements?
• □ Are the reporting flows for shipment suspension and supply shortfall linked with the licensed entity?

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 coordinates In-Country Representative arrangements, marketing authorisation holder duties, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com