Post-Marketing Performance Evaluation: Survey Obligations as Approval Conditions

1. Key takeaways

Post-marketing performance evaluation is the system by which Japan makes post-approval data collection a condition of the approval itself: for designated items, the approval and the investigation obligation arise simultaneously. It is both an accelerated-launch tool and a long-term compliance burden. From 1 May 2026, items designated for performance evaluation must submit, as related information, tabular lists of malfunctions and infection cases occurring abroad. This is the concrete operational change introduced in the latest revision cycle.

• Article 23-2-9(1) of the PMD Act empowers the Minister of Health, Labour and Welfare to designate medical devices or in vitro diagnostics subject to performance evaluation.
• Paragraph (6) obliges designated holders to conduct performance-related and other ordinance-defined investigations and report the results to the Minister.
• The operative notice is Yakushokukisanhatsu No. 1121-44 of 21 November 2014, on the handling of performance evaluation for approvals.
• A partial revision of that notice applies from 1 May 2026, driven by Act No. 37 of 2025 and MHLW Ordinance No. 117 of 2025.
• GRZAN’s assessment: the evaluation clock runs from the approval date, and managing it separately from the five-year QMS cycle is the discipline most holders lack.
• For Chinese manufacturers the practical weight of the system is double: it can shorten the road to an approval for designated items, and it simultaneously creates a standing investigation and reporting workload that must be resourced from the first day on the market.

2. Legal basis

Designation power. Under Article 23-2-9(1) of the PMD Act, the Minister of Health, Labour and Welfare may designate medical devices or in vitro diagnostics for which performance evaluation must be conducted. Designation attaches to the item and follows it through the approval.

Investigation and reporting duty. Under paragraph (6), a designated holder must conduct investigations relating to use results and other investigations specified by MHLW ordinance, and report the results to the Minister. The obligation begins with the approval and persists for as long as the designation stands.

Operative notice. The notice of the Counsellor’s Office (medical device and regenerative medicine products review management) on the handling of performance evaluation relating to manufacturing and sales approvals, Yakushokukisanhatsu No. 1121-44 of 21 November 2014, sets the operational detail.

2026 partial revision. A partial revision of that notice, issued jointly by the MHLW Pharmaceutical and Medical Device Evaluation Management Division and the Pharmaceutical Safety Countermeasures Division, was made upon the enforcement of Act No. 37 of 2025, promulgated on 21 May 2025, and MHLW Ordinance No. 117 of 2025, and applies from 1 May 2026 (Reiwa 8).

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

3. Expert insights

Performance evaluation is the institutional prototype of conditional approval. Article 23-2-9 predates conditional approval and shares its logic: investigation obligations after the approval are exchanged for an earlier approval point. Understanding this explains what the conditions of Article 23-2-6-2 actually look like in operation, since performance evaluation is one existing species of such a condition. For applicants weighing the conditional route, the mature practice built around Article 23-2-9, from protocol design to reporting formats, is the closest available preview of the obligations they would assume.

The 2026 revision performs both subtraction and addition. The subtraction: Act No. 37 of 2025 and MHLW Ordinance No. 117 of 2025 render the 30-day malfunction reporting for known deaths or serious cases from foreign medical devices no longer necessary. The addition: for items designated for performance evaluation, malfunctions and infection cases occurring abroad must be compiled in a tabular list in the prescribed format and submitted as related information for the evaluation. The reporting architecture shifts from individual-case reports toward aggregated information, and holders must rebuild their foreign-case collection to feed the list format rather than the old per-case flow. Collection procedures, case definitions and the internal handover from overseas markets to the Japanese holder all need revision before the new format applies, since a tabular list is only as complete as the case feed beneath it.

Bind the reporting clock to the approval date. The investigation and reporting obligations of performance evaluation run from the approval. GRZAN advises treating the approval date as the anchor of the compliance calendar, with the performance-evaluation reports, the periodic QMS conformity investigations on their five-year cycle and the periodic safety reports each kept in separate tables, so that the cycles do not overwrite one another. Where the approval date drifts in planning, every downstream obligation drifts with it silently.

4. Practical recommendations

• Assess the likelihood of designation for performance evaluation at the project stage. New medical devices and high-risk implants carry a higher likelihood, and the investigation cost belongs in the project budget from the start.
• Build the compliance calendar on the approval date, with performance-evaluation reports, QMS periodic investigations and periodic safety reports in separate tables.
• From 1 May 2026, submit foreign-case information in the new tabular list format, following the annexed formats of the revised notice.
• Complete the investigation protocol design before the approval, aligning the design and sample size with PMDA at the consultation stage.
• When citing the original notice, quote the full reference: Yakushokukisanhatsu No. 1121-44 of 21 November 2014.

5. Verification checklist

• □ Has the likelihood of designation for performance evaluation been assessed and budgeted?
• □ Has the switch to tabular-list submission of foreign-case information from 1 May 2026 been confirmed?
• □ Is the compliance calendar anchored on the approval date and managed separately from the QMS periodic cycle?
• □ Was the investigation protocol designed before approval and aligned with PMDA?
• □ When citing the original notice, are the full number and date (Yakushokukisanhatsu No. 1121-44, 21 November 2014) used?

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