Recall Reporting and Urgent Safety Information in Japan

1. Key takeaways

Recall reports and malfunction reports in Japan are two parallel statutory reporting lines: malfunction reports rest on Article 68-10 and recall reports on Article 68-11, and neither can substitute for the other. The executing party is the marketing authorization holder, the reports go to the Ministry of Health, Labour and Welfare (in practice through PMDA), and MHLW aggregates the status annually and reports it to the Pharmacy Council. A malfunction can exist without any product being recalled, and a recall can be decided without a reportable malfunction having occurred, so the two lines each require their own trigger analysis, their own documentation and their own submission. Treating them as one undifferentiated reporting duty is the root cause of most missed filings in this area.

• Article 68-10 governs malfunction reporting; Article 68-11 governs recall reporting.
• The two lines cover different facts and can be triggered by the same event independently.
• The MAH executes both lines; reports go to MHLW, in practice via PMDA.
• MHLW reports the annual status to the Pharmacy Council under Article 68-12. The dual-line design means a company needs two procedures, two trigger lists and two sets of records even where the underlying event is the same.

2. Legal basis

The dual-line structure described in the source guidance rests on the following provisions of the current framework (Act No. 145 of 1960) and on the MHLW notification governing recall judgment and implementation. Citations are reproduced in the same terms and should be verified against the current text before they are relied on in an actual case. The recall judgment criteria and the implementation procedure in the notification are the operational reference for both the decision whether to recall and the execution of the recall once decided.

1. PMD Act Article 68-11: recall reporting by the MAH and related parties.
2. PMD Act Article 68-10: malfunction reporting by the MAH and related parties, and by medical professionals — the parallel line alongside recall reporting.
3. PMD Act Article 68-12: the Minister of Health, Labour and Welfare must report each year to the Pharmacy Council on the status of malfunction and recall reporting, and must hear opinions and take harm-prevention measures as needed.
4. PMD Act Article 68-13, paragraph 3: reports are submitted to PMDA.
5. PMDA / MHLW notification on recalls of pharmaceuticals and medical devices, PFSB Notification No. 1121-10, November 21, 2014: the judgment criteria for the necessity of a recall and the implementation procedure (software devices are subject to the same criteria).
6. Current legal framework: Act No. 145 of 1960.

3. Expert insights

Insight 1: the two reporting lines cover different facts. Malfunction reporting covers the occurrence of a malfunction, or health damage suspected to have been caused by a malfunction; recall reporting covers the taking of a recall as a measure. A single event may trigger both reporting duties at once, or only one of them, and the determination must be made expressly for each line rather than assumed from the other. The common failure mode is that a company completes the malfunction report and overlooks the recall report. Keeping the trigger analysis for the two lines in a single combined list, with a marker showing which line each fact activates, prevents the second line from being forgotten once the first has been filed.

Insight 2: reporting status is aggregated annually and reported to the Pharmacy Council. Article 68-12 requires the Minister to report each year to the Pharmacy Council on the status of reporting under the two preceding articles. This mechanism gives recall and malfunction data annual traceability, which companies can use to understand the vigilance posture of their peers and product categories. For an individual company, the published aggregate is also a benchmarking input: the categories and volumes of recalls within a product class indicate where regulatory attention is concentrated, and where a company’s own internal thresholds may need to be examined.

Insight 3: software devices are subject to the same recall criteria. The PMDA notification on the handling of software-based medical devices makes clear that the criteria for judging the necessity of a recall of a software device, and the implementation procedure, are the same as for other medical devices. Cloud-delivered software can equally trigger a recall; only the execution method differs. What changes is the mechanics of carrying it out — withdrawing physical units, rolling back versions, or deactivating remotely — not the standard applied when deciding whether a recall is necessary.

4. Practical recommendations

• Build a dual-line trigger list covering recalls and malfunctions. Specify which facts trigger which reporting line, so that the filing of one report does not silently close the analysis of the other.
• Rehearse the recall procedure before it is ever executed. Notification routing, determination of recall scope and effectiveness confirmation should all be documented in advance, since all three tend to fail under time pressure if they are being designed for the first time during an actual event.
• Pre-design recall execution methods for software products. Version rollback, remote deactivation and user notification are the three paths to design ahead of time, each with its own verification step to confirm the corrective action actually reached the deployed population.
• Monitor the reporting status published by PMDA. Use it for peer benchmarking and for calibrating internal vigilance thresholds, particularly for product classes where published recall activity is high.

5. Verification checklist

• □ Has a dual-line trigger list for recall reports and malfunction reports been built?
• □ Is the recall procedure (notification, scope determination, effectiveness confirmation) documented and rehearsed?
• □ Are recall execution paths pre-designed for software products (version rollback, remote deactivation, notification)?
• □ Is the recall reporting basis confirmed as Article 68-11 and the malfunction reporting basis as Article 68-10?
• □ Is the annual aggregation and Pharmacy Council reporting mechanism of Article 68-12 understood?

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