Conditional Approval under Article 23-2-6-2: Statutory Route from May 2026

1. Key takeaways

Japan’s conditional approval has passed through three stages: operation by notification in 2017, legalization in 2020, and statutory reconstruction in 2026. Act No. 37 of 2025 newly established Article 23-2-6-2 of the PMD Act, writing approval granted subject to the conduct of studies into the statute itself, effective from 1 May 2026. For Chinese innovative-device manufacturers this converts the previous deadlock of unfeasible clinical studies into a negotiable submission condition.

• Article 23-2-6-2(1) sets three requirements: high medical necessity, reasonably predictable efficacy or performance, and no prediction that serious adverse effects render the product worthless.
• Paragraph (2) obliges the conditional holder to submit data from studies conducted under MHLW ordinance and to undergo investigations of quality, efficacy and safety.
• The operational notice Iyakukishinhatsu No. 0331-23 of 31 March 2026 applies from 1 May 2026.
• The prior conditional early approval scheme ran under Yakuseihatsu No. 0731-1 of 31 July 2017 and was legalized on 1 September 2020.
• GRZAN’s assessment: the decisive gate is PMDA’s requirement of a prior development consultation; applicants who skip it cannot access the route at all.

2. Legal basis

Amending statute. The Act Partially Amending the Acts to Secure the Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices and Related Products, Act No. 37 of 2025, promulgated on 21 May 2025, newly established Article 23-2-6-2 of the PMD Act, conditional approval. The Act takes effect in stages from 20 November 2025, with conditional approval in the part effective on 1 May 2026.

Three requirements. Under Article 23-2-6-2(1), the item must be a medical device with particularly high medical necessity, such as a device for rare diseases, a pioneering medical device or a device for specified uses; its effect or performance must be reasonably predictable; and it must not be reasonably predicted to have no value in use because of serious adverse effects. Paragraph (2) requires the holder to submit materials produced from studies conducted under MHLW ordinance and to undergo investigations of quality, efficacy and safety.

Conditions content. Beyond the condition of conducting the studies specified by MHLW ordinance, the Minister may attach measures necessary to ensure proper use and other necessary conditions. These are real post-approval obligations of investigation and risk management, not documentary formalities.

Operational notice. The MHLW notice on the handling of conditional approval for medical devices and in vitro diagnostics, Iyakukishinhatsu No. 0331-23 of 31 March 2026, applies from 1 May 2026, together with the related notices on risk management plans.

Predecessor scheme. PMDA’s public materials record that the original conditional early approval scheme, targeting innovative devices for diseases with major life impact, no existing effective therapy and extremely difficult clinical development, operated under the notice Yakuseihatsu No. 0731-1 of 31 July 2017 and was legalized on 1 September 2020. Act No. 37 of 2025 rebuilt the provisions, extended the scope and clarified the supporting measures.

Current legal corpus. Act No. 145 of 1960 (the PMD Act).

3. Expert insights

The three requirements combine necessity, predictability and a veto line. Item 1 of paragraph (1) restricts the subjects to items of high medical necessity; item 2 lowers the evidentiary standard from proven to reasonably predictable; item 3 sets the veto line, excluding items for which serious adverse effects are reasonably predicted to leave no value in use. The decisive element is item 2: it converts the demand for clinical evidence from a judgment of certainty into a judgment of reasonable prediction. This is precisely why the route matters for products whose pivotal studies are infeasible, and why the argument must still be built rigorously around what can be predicted from existing data.

The conditions are study conduct plus proper-use safeguards. Paragraph (1) allows the Minister to attach, in addition to the condition of conducting studies specified by ordinance, the measures necessary to ensure proper use and other necessary conditions. GRZAN’s reading for clients: these conditions are executed obligations with consequences. Failure to perform the post-approval studies affects the maintenance of the approval. The feasibility of genuinely running the post-marketing study, with budget and operational capacity, belongs in the route decision, not after approval.

The 2017 notification scheme is the direct predecessor. PMDA’s public materials record that the earlier scheme for innovative devices with major life impact and no effective existing therapy, where clinical development was judged extremely difficult, ran under the 31 July 2017 notice and was legalized on 1 September 2020. Act No. 37 of 2025 then reconstructed the provisions, extended the applicable scope and clarified the supporting measures. Understanding the lineage matters because the operational guidance accumulated under the predecessor remains the best available indication of how the authorities weigh necessity and predictability.

4. Practical recommendations

• Add conditional approval to the route-assessment list for innovative devices, evaluating its applicability at the route-design stage for items where large randomized controlled studies are difficult.
• Treat PMDA consultation as a hard gate. The authority requires applicants for conditional approval to undergo a development consultation for medical devices or for in vitro diagnostics and to confirm the implementation method.
• Prepare the risk management plan in parallel with the application, since Iyakukishinhatsu No. 0331-23 applies together with the related risk-management notices.
• Build the real execution capacity and cost of post-approval studies into the feasibility judgment; non-performance affects maintenance of the approval and is not a formal condition.

5. Verification checklist

• □ Has the self-assessment against the three requirements of Article 23-2-6-2(1) been completed?
• □ Has the PMDA development consultation been arranged, with the consultation record retained?
• □ Has the risk management plan been prepared in step with the application?
• □ Has it been confirmed that the effective date is 1 May 2026 and the applicable notice is Iyakukishinhatsu No. 0331-23?
• □ Have the real execution capacity and cost of the post-approval study been assessed?

Regulatory information verified as at 29 October 2026. Legal texts follow the current provisions published on e-Gov and the notices issued by MHLW and PMDA, and must be rechecked after amendment or repeal. Time limits and procedural details reflect the official position on that date; content marked practical estimate has no legal effect.

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 PMDA premarket submissions and notification procedures, coordinates clinical evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com