Abolition of 30-Day Reporting for Foreign Known Cases

1. Key takeaways

From May 1, 2026, Japan no longer requires a 30-day malfunction report for foreign-origin, known (already described in the package insert) cases of death or serious health damage. This is a concrete burden reduction delivered by Act No. 37 of 2025 (Reiwa 7) and the accompanying MHLW Ordinance No. 117 of 2025 (Reiwa 7). The substitute obligation is that, for items designated for use-results evaluation, a list of malfunction and infection occurrences must be prepared in the prescribed format and submitted as related information for that evaluation. The reporting duty is thus reshaped rather than removed: what disappears is the individual 30-day submission, and what appears in its place is structured aggregate information feeding the use-results evaluation.

• The 30-day individual report is abolished for foreign-origin known death and serious cases from May 1, 2026.
• Legal basis: Act No. 37 of 2025 and MHLW Ordinance No. 117 of 2025.
• Replacement duty: a formatted occurrence list submitted as related information for designated use-results evaluation items.
• Domestic cases, unknown cases and trend-change situations remain fully reportable.

2. Legal basis

The change is a statutory amendment with a dedicated implementing ordinance and a revised MHLW notification. The citation list below reproduces the source guidance item by item, and each element should be re-confirmed against the current text on e-Gov before it is relied on.

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. The MHLW ordinance-arrangement ordinance accompanying enforcement of that act, MHLW Ordinance No. 117 of 2025 (Reiwa 7).
3. MHLW notification on the partial revision of the handling of use-results evaluation relating to manufacturing and marketing approval of medical devices and in vitro diagnostic pharmaceuticals (original notification: Yakushoku Kisanhatsu No. 1121-44, November 21, 2014); the revised portion applies from May 1, 2026 (Reiwa 8).
4. Core of the revision: with the enforcement of the act and ordinance above, a 30-day malfunction report is no longer required for known cases of death or serious health damage occurring in foreign countries.
5. Substitute obligation: for items designated for use-results evaluation, in respect of (i) cases reported under Article 228-20, paragraph 2 of the Implementing Rules as revised, and (ii) deaths and cases of serious health damage listed in Article 228-20, paragraph 1, item 1 of the Implementing Rules, a list of malfunction and infection occurrences is prepared in the format of appended form 4-2 and submitted as related information for the use-results evaluation.
6. Current legal framework: Act No. 145 of 1960.

3. Expert insights

Insight 1: this is a subtraction-plus-addition package, not a simple abolition. The subtraction is clear: foreign-origin known death or serious cases no longer go through a 30-day individual report. The addition is equally clear: items designated for use-results evaluation must submit the occurrence status of foreign malfunctions and infections in list form. For Chinese manufacturers, the first half lowers operational frequency, while the second half requires the capability to aggregate overseas cases. Operationally the two halves must be implemented together; deleting the old branch from the triage table without standing up the aggregation ledger would leave a gap in which such cases are neither individually reported nor aggregated.

Insight 2: the scope is limited to foreign origin and known status. What is exempted is death or serious cases that occurred abroad and that are known, meaning already described in the package insert. Cases occurring inside Japan, unknown cases, and situations showing a change in trend are not within the exemption. A company must not read this provision as foreign cases no longer matter. The practical test at every case is therefore twofold: where did the event occur, and is it described in the package insert. Only when both answers point to foreign origin and known status does the exemption apply.

Insight 3: the change is consistent with PMDA’s overall direction of vigilance efficiency. PMDA public material shows that foreign reports account for a markedly higher share of device malfunction reports than domestic reports. This adjustment concentrates individual-report resources on unknown events and trend-change signals in terms of total volume management; it is a reallocation of vigilance resources, not a relaxation of oversight. The resource rationale also explains why the substitute obligation takes list form: aggregate data allow trend analysis without consuming the individual-report channel.

4. Practical recommendations

• Update the internal reporting triage table. Remove the 30-day branch for foreign known death and serious cases, and retain the branches for unknown events and trend changes, so that no foreign case is silently dropped from any track.
• Build an overseas-case aggregation ledger for items designated for use-results evaluation. Collect data according to the fields of appended form 4-2 on an ongoing basis, capturing each case as it arises in the source country rather than reconstructing records in a year-end catch-up exercise.
• Retain the 15-day and 30-day workflows for domestic Japanese cases and unknown cases. The two tracks should not be merged.
• After the verification date, confirm the regime is in force and check for follow-up notifications. This milestone took effect on May 1, 2026; it is prudent to re-confirm the current state before relying on it in practice.

5. Verification checklist

• □ Has the internal reporting triage table removed the foreign-known-death-and-serious 30-day branch?
• □ Has an overseas-case aggregation ledger been set up for items designated for use-results evaluation?
• □ Are the 15-day and 30-day workflows for domestic cases and unknown cases fully retained?
• □ Has the legal basis of this change been confirmed as Act No. 37 of 2025 and MHLW Ordinance No. 117 of 2025?
• □ Has the application date of May 1, 2026 been confirmed, and have follow-up notifications been re-checked?

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