Conditional Approval: Notice No. 0331-23 Operational Requirements

1. Key takeaways

Article 23-2-6-2, newly created by Act No. 37 of 2025 (Reiwa 7), provides the statutory framework, and MHLW Notification Iyaku Kishinhatsu No. 0331-23 (March 31, 2026) provides the operational guidance; both apply from May 1, 2026. For Chinese innovative device manufacturers, two hard gates stand between them and the use of this system: completion of a PMDA pre-development consultation and preparation of a risk management plan. Both gates operate before any dossier is filed, which places the decisive work at the development stage rather than at submission.

• The statutory framework is Article 23-2-6-2; the operational guidance is Notification No. 0331-23.
• Both apply from May 1, 2026.
• A PMDA pre-development consultation is an entry requirement, not an optional service. A risk management plan is a principal vehicle for the conditions attached to approval. Together these two gates define where the real preparation work sits for any manufacturer considering this route.

2. Legal basis

The conditional approval regime rests on the amendment act, the new article, the operational notification and the related guidance listed below, reproduced in the same terms as the source guidance. Notification numbers and dates not fixed in the law are as published by MHLW for the time being and should be re-confirmed before reliance. Read together, the items below show that the regime combines a statutory route with operational guidance, and that both layers carry requirements the applicant must satisfy.

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; creating PMD Act Article 23-2-6-2 (conditional approval).
2. PMD Act Article 23-2-6-2, paragraph 1: the subjects are medical devices for rare diseases, pioneering medical devices, specific-use medical devices and other products of particularly high medical necessity; the requirements are that the efficacy or performance claimed in the application can reasonably be predicted, and that the product is not without use value on the ground that significantly harmful effects are reasonably predicted.
3. PMD Act Article 23-2-6-2, paragraph 2: a holder of conditional approval must submit materials prepared from studies conducted under the MHLW ordinance, and undergo investigations of quality, efficacy and safety.
4. MHLW notification on the handling of conditional approval of medical devices and in vitro diagnostic pharmaceuticals, Iyaku Kishinhatsu No. 0331-23, March 31, 2026, applicable from May 1, 2026.
5. Related notifications: those on risk management plans (the notification on preparation and publication of risk management plans and the risk management guidance, both issued August 31, 2020; and the former notification on conditional early approval) — numbers and dates as published by MHLW for the time being.
6. PMDA public material: an applicant for conditional approval must undergo a medical device pre-development consultation or an in vitro diagnostic pre-development consultation.
7. Current legal framework: Act No. 145 of 1960.

3. Expert insights

Insight 1: the advance consultation is the entrance to the system, not an optional service. PMDA makes clear that an applicant wishing to apply under conditional approval must undergo a medical device pre-development consultation or an in vitro diagnostic pre-development consultation. The traditional sequence of preparing the dossier first and applying afterwards does not hold here; the correct sequence is to consult first, then design the development plan and the study plan. Treating the consultation as the entry point also changes internal planning: The consultation slot, its preparation and its outcomes become early program milestones rather than late-stage advisory steps, and the study plan agreed at consultation effectively frames what the conditional approval will require afterwards.

Insight 2: the content of the conditions is studies plus measures to ensure proper use. Paragraph 1 provides that, in addition to conditions imposing the conduct of studies prescribed by MHLW ordinance, measures necessary to ensure proper use and other necessary conditions may also be attached. The risk management plan is an important vehicle for the latter category. In preparing it, the measures for proper use and the study obligations should be presented together, since the regulator evaluates the sufficiency of the condition package as a whole.

Insight 3: the eligible subjects overlap with pioneering designation and priority review, but neither substitutes for the other. The three categories of rare-disease, pioneering and specific-use devices overlap heavily with the subjects of pioneering designation, yet conditional approval answers the question of how to approve with insufficient evidence, while pioneering designation answers how to accelerate review. The two should be assessed separately and can be pursued simultaneously. A product can therefore hold several designations at once, and the application strategy should map which mechanism contributes what to review speed and to evidence expectations.

4. Practical recommendations

• Start the PMDA pre-development consultation early in development. System applicability and study design should be tabled together as consultation topics, since the answers to both determine whether the conditional route is viable for the product.
• Prepare the risk management plan in step with the application. Submit it with the application dossier rather than supplementing it after approval, since conditions attached at approval are expected to be executable from the outset.
• Write the capacity to execute post-approval studies into the feasibility assessment. Non-performance of conditions can affect the maintenance of the approval, which makes execution capacity a condition of the pathway itself rather than an operational afterthought.
• Assess alongside pioneering designation and priority review. The three acceleration mechanisms can be pursued together; it is not a choice of one out of three.

5. Verification checklist

• □ Is the PMDA pre-development consultation arranged (medical device or in vitro diagnostic pre-development consultation)?
• □ Is the risk management plan being prepared in step with the application?
• □ Are the applicable notification confirmed as Iyaku Kishinhatsu No. 0331-23 (March 31, 2026) and the application date May 1, 2026?
• □ Has the self-assessment been completed against the three requirements of Article 23-2-6-2, paragraph 1?
• □ Is the capacity to execute post-approval studies included in the feasibility assessment?

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