Use-Results Evaluation and Periodic Safety Reporting in Japan

1. Key takeaways

Japanese post-market obligations contain two separate periodic regimes with different start points: use-results evaluation runs from the approval date and is an individual condition attached at the time of approval, while periodic reporting under Article 228-20, paragraph 2 of the Implementing Rules aggregates collected unknown, non-serious malfunctions and similar events on a periodic basis. GRZAN recommends maintaining the two timetables as separate tables rather than merging them into a single annual reporting list. A third timetable — the QMS periodic conformity review — also runs on its own cycle and must be tracked independently. Each regime answers a different question: use-results evaluation examines how the product performs in actual use, while periodic reporting ensures that unknown signals are not lost between individual reports, and the two cannot be consolidated without losing information.

• Use-results evaluation is an individually designated approval condition running from the approval date.
• Periodic reporting under Article 228-20, paragraph 2 aggregates unknown non-serious events.
• The QMS periodic conformity review runs at intervals not exceeding 5 years from the approval date.
• Different start events, cycle lengths and recipients mean the timetables must never be merged. A merged calendar hides the differing anchors and produces missed dates precisely because the regimes look similar on the surface.

2. Legal basis

The two periodic regimes, and the third QMS timetable referenced in the source guidance, rest on the following provisions of the current framework (Act No. 145 of 1960) and related instruments. Citations are reproduced in the same terms and should be verified against the current text before use. The three obligations differ not only in trigger and length but also in what they ask the company to produce, which is why each needs its own owner within the compliance function.

1. PMD Act Article 23-2-9, paragraph 1: the Minister of Health, Labour and Welfare may designate items for which use-results evaluation must be conducted.
2. PMD Act Article 23-2-9, paragraph 6: a designated holder must conduct surveys of use results and other surveys prescribed by ordinance, and report the results to the Minister.
3. Implementing Rules Article 228-20, paragraph 2: depending on the degree of health damage, reporting within 15 days or 30 days from the day of awareness, or submission as a periodic report.
4. MHLW notification on the handling of use-results evaluation relating to manufacturing and marketing approval of medical devices and in vitro diagnostic pharmaceuticals, Yakushoku Kisanhatsu No. 1121-44, November 21, 2014; and its 2026 partial revision (applicable from May 1, 2026).
5. PMD Act Article 23-2-5, paragraph 7 and the Implementation Order Article 37-21: the QMS periodic conformity review cycle (at intervals not exceeding 5 years) — the third timetable.
6. Current legal framework: Act No. 145 of 1960.

3. Expert insights

Insight 1: three timetables, three start points — mixed management will fail. Use-results evaluation runs from approval; periodic reporting runs on the cycle set by the Implementing Rules; the QMS periodic conformity review runs at intervals of not more than 5 years from the approval date. The triggering events, cycle lengths and submission recipients all differ. In practice GRZAN typically builds a relative-date table anchored on the approval date, expressing all three obligations in the form of approval date plus N months or years. A relative-date table also survives later procedural changes better than a list of absolute dates, because the obligations re-anchor automatically whenever the anchor event changes. It also makes dependencies visible: a delay at one obligation never silently shifts another, because each line carries its own anchor and its own owner.

Insight 2: use-results evaluation is an individual designation system, not a universal duty. Article 23-2-9, paragraph 1 vests the designation power in the Minister of Health, Labour and Welfare, so only designated items carry this obligation. A company should confirm at the time of approval whether its product has been designated, and record the designation in its compliance calendar. The check belongs in the approval-handling procedure itself, not in an after-the-fact review, because the obligation attaches from the moment of designation.

Insight 3: the 2026 revision brings foreign case information into the related information of the evaluation. As revised, the notification requires designated items to prepare a list of foreign malfunctions and infection occurrences in the prescribed format and submit it as related information for the use-results evaluation. The composition of the use-results evaluation package therefore changed after May 1, 2026. The evaluation dossier now carries a standing foreign-case component, and the ledger feeding it must be maintained continuously rather than assembled at submission time.

4. Practical recommendations

• Build a relative-date table anchored on the approval date. Express all three obligations as approval date plus N, avoiding misrecorded absolute dates.
• Confirm designation for use-results evaluation immediately upon approval. Make the designation entry the first item in the compliance calendar, so that every downstream schedule derives from it.
• Keep the aggregation scope of periodic reports strictly separate from individual reports. Unknown non-serious events go into periodic reporting and never through the 15-day or 30-day workflow, since mixing the two tracks distorts both the aggregate data and the deadline management.
• Build the foreign-case ledger on the field structure of the post-2026 format. The fields should correspond to the appended form, so that the ledger can be rendered into the required list without manual re-mapping at submission time.

5. Verification checklist

• □ Was designation for use-results evaluation confirmed at the time of approval?
• □ Is the compliance calendar anchored on the approval date, with the three obligations expressed as approval date plus N?
• □ Are the aggregation scopes of periodic reporting and individual reporting (15 days / 30 days) strictly separated?
• □ Are the foreign-case ledger fields built on the post-2026 revised format?
• □ Is the 5-year QMS periodic conformity review cycle tracked in its own table (Implementation Order Article 37-21)?

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