Special Approval under Article 23-2-8: Emergency Use and Supply Shortage Route

1. Key takeaways

Special approval under Article 23-2-8 of the PMD Act is a narrow gate Japan keeps for urgent situations with no alternative means. Its statutory requirements are narrower than conditional approval and lean toward public-health emergency and supply security. Act No. 37 of 2025 further brought in the situation where demand for an already approved item is markedly unmet. GRZAN’s judgment: this route is not a routine option for the overwhelming majority of Chinese manufacturers, but understanding its division of labour with conditional approval helps them correctly assess which one, if any, applies.

• Article 23-2-8(1) sets two requirements: urgent need to prevent the spread of health hazards, and no appropriate means other than using the item.
• The item must already be approved for sale, grant, storage and display, or provision over telecommunication lines in a foreign country designated by Cabinet Order.
• Act No. 37 of 2025, promulgated on 21 May 2025, added elements on identity with approved devices in designated countries and on markedly unmet demand for approved items.
• Article 23-2-6-2, conditional approval, is the contrast anchor: its anchor is predictability, while special approval’s anchor is urgency.
• GRZAN’s assessment: applicability hinges on the Cabinet Order list of designated countries, which can change, so it must be checked rather than assumed.
• Because the route is demand-driven rather than applicant-driven, the working assumption in any project plan should be that the route is unavailable unless the public-health or supply-shortage situation independently supports it.

2. Legal basis

Two statutory requirements. Under Article 23-2-8(1) of the PMD Act, special approval applies where, first, use is urgently needed to prevent the expansion of health hazards such as the spread of diseases seriously affecting the lives and health of the public, and there is no appropriate method other than using the item; and second, the item has already been approved for sale, grant, storage and display, or provision over telecommunication lines in a foreign country designated by Cabinet Order as being at a level equivalent to Japan in securing the quality, efficacy and safety of medical devices.

The 2025 amendment. Act No. 37 of 2025, promulgated on 21 May 2025, added to the special approval subject-matter the elements of identity with an already approved medical device and prior approval in a Cabinet Order-designated foreign country, and of markedly unmet demand for the approved item with no other medically appropriate method. This aligns the route with the same amendment’s broader direction of strengthening stable-supply responsibilities.

Contrast anchor. Article 23-2-6-2 of the PMD Act, conditional approval, provides the comparison point for assessing which narrow route, if any, an innovative or substitute product fits.

Current legal corpus. Act No. 145 of 1960 (the PMD Act); Act No. 84 of 2013, promulgated on 27 November 2013.

3. Expert insights

Special approval rests on urgency; conditional approval rests on predictability. Item 1 of Article 23-2-8(1) requires urgent need to prevent the expansion of health hazards, while item 2 of Article 23-2-6-2(1) requires reasonably predictable effect or performance. The former interrogates public-health urgency; the latter interrogates the predictability of evidence. The internal logic of the two routes differs, and they should not be conflated. A product that qualifies for one may fail the other entirely, so the first analytical step is to identify which question the product’s situation actually answers. GRZAN uses this division as the opening screen in every narrow-route assessment.

The designated-country list is a movable one. Item 2 of Article 23-2-8(1) restricts the relevant foreign countries to those designated by Cabinet Order as being at a level equivalent to Japan in securing the quality, efficacy and safety of medical devices. Usability of the route therefore depends on the Cabinet Order list, not on a company’s own assessment of its home regulator’s standing. The list can change, and a change directly alters the route’s availability. Before any planning that touches this route, verify the current list rather than relying on prior project knowledge.

The 2025 amendment wrote supply security into the requirements. The amended text of Act No. 37 of 2025 added the wording on markedly unmet demand for approved items. This sits consistently with the same amendment’s overall direction of strengthening stable-supply responsibilities: Japan is lifting supply shortage from the level of administrative guidance into a consideration of the approval system itself. For foreign manufacturers, this creates a narrow but real scenario where an approved item’s supply gap in Japan, combined with an identical product approved abroad, opens a discussion with the authorities that previously had no statutory footing.

4. Practical recommendations

• Do not build routine registration plans around special approval; its threshold depends heavily on public-health urgency and the Cabinet Order list.
• Track updates to the Cabinet Order list of designated foreign countries, because changes directly alter the route’s applicability.
• Where a supply shortage arises, assess the new elements and communicate with the authorities in advance if an identical approved product exists overseas and the approved item’s demand is markedly unmet in Japan.
• Run the comparison with conditional approval as a standing exercise: innovative items look first to conditional approval, urgent substitutes look first to special approval.

5. Verification checklist

• □ Is the project goal closer to urgent substitution or to early approval of an innovation?
• □ Has it been confirmed that the foreign country relied on falls within the Cabinet Order designation?
• □ Has the self-assessment against the two requirements of Article 23-2-8(1) been completed?
• □ In a supply-shortage scenario, has there been advance communication with the authorities on the new elements?
• □ Has special approval been kept out of the routine registration plan?

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