GVP Ordinance and Post-Market Safety Management in Japan

1. Key takeaways

Post-market safety management in Japan is borne by the marketing authorization holder (MAH, the seizo hanbai gyosha) as the single responsible entity, and the organizational framework for that duty is the GVP Ordinance (MHLW Ordinance No. 170 of 2004). The reporting obligations run in both directions: the MAH must report device malfunctions to the Ministry of Health, Labour and Welfare (MHLW) — in practice through PMDA — while medical professionals are also under a duty to report when they consider it necessary. GRZAN treats the construction of a GVP-compliant safety system as a mandatory work package to be completed before a Japan project is approved, not as a remedial item to be patched together after approval. In other words, the safety system is part of the approval-readiness package itself: the organization, its responsibilities and its information flows must be demonstrably in place at the point the product enters the Japanese market, because the same system then carries every post-market duty that follows.

• The MAH is the single responsible party for post-market safety; a foreign manufacturer cannot discharge this duty directly.
• Reporting is bidirectional: the MAH reports malfunctions, and medical professionals report when they deem it necessary.
• The GVP Ordinance governs the safety system as an organization, while reporting deadlines and formats come from other instruments.
• GRZAN schedules GVP system building before first shipment and before approval is granted.

2. Legal basis

The obligations summarized above rest on the following provisions of the current legal framework (Act No. 145 of 1960, the PMD Act) and its subordinate instruments. Each item is cited in the same terms as the source guidance, and the numbering should always be re-confirmed against the current text on e-Gov before it is quoted in any submission.

1. PMD Act Article 68-10, paragraph 1: the MAH and related parties must report when they come to know of a device malfunction, a disease, injury or death suspected to have been caused by a malfunction, or an infection suspected to result from use of the device.
2. PMD Act Article 68-10, paragraph 2: medical professionals who come to know of malfunctions suspected to be related to a device, and who consider it necessary to take active measures to prevent or contain harm to health, must report to PMDA.
3. PMD Act Article 68-13, paragraph 3: since April 2004, these reports are to be submitted to PMDA.
4. The Ordinance on Standards for Post-Marketing Safety Management of Medical Devices (the GVP Ordinance), MHLW Ordinance No. 170 of 2004.
5. PMD Act Article 68-12: the Minister of Health, Labour and Welfare must report each year to the Pharmacy Council on the status of reporting under the two preceding articles, and must hear opinions and take harm-prevention measures as needed.
6. Current legal framework: Act No. 145 of 1960.

3. Expert insights

Insight 1: the reporting party is the MAH, and a foreign manufacturer cannot report to the regulator directly. Article 68-10, paragraph 1 imposes the duty on the marketing authorization holder. Even where a foreign manufacturer holds an approval as the recipient of special foreign approval, the reporting act itself is performed in Japan by the designated MAH (D-MAH). This makes it essential to establish a verifiable information-transfer channel between the foreign manufacturer and the D-MAH, because the timeliness of that transfer directly determines when the reporting clock starts to run. In practical terms, every malfunction known to the overseas manufacturer must reach the D-MAH quickly enough for the statutory deadline to be met, which is why the transfer channel should be contractual, documented and testable rather than informal.

Insight 2: the reporting duty of medical professionals is one of the information sources feeding the Japanese vigilance system. Article 68-10, paragraph 2 sets out the duty of medical institutions independently and directs it to PMDA. The practical consequence is that a company cannot assume the hospital will tell it first; an active information-collection mechanism on the clinical side must be built deliberately. Complaint intake, structured follow-up with users and monitoring of publicly reported events complement what the regulator receives directly from hospitals and give the company its own complete picture of the device’s behavior in use.

Insight 3: the GVP Ordinance governs the system, not the reporting act. The GVP Ordinance sets the implementation standards for organizational structure, information collection, assessment and the execution of safety-assurance measures; the specific reporting deadlines and formats are set by the implementing rules and MHLW notifications. When building the system, companies should construct the system documentation and the reporting workflow as two separate bodies of work and then cross-reference them. In practice this separation keeps the system documents stable across organizational checks while the operational documents evolve with each change in notification practice.

4. Practical recommendations

• Complete the GVP system before approval. Organization, responsibilities, information-collection channels, assessment processes and safety measures — all five elements should be in place before the first shipment, so that no device reaches a Japanese user under a safety system that exists only on paper.
• Put a written information-transfer agreement in place between the foreign manufacturer and the D-MAH. Define transfer deadlines, the data fields to be conveyed and the responsible persons on each side.
• Build an information-collection mechanism directed at the clinical side. Do not rely on passive receipt; set up proactive follow-up and complaint-handling channels.
• Include the annual report and publicly available Pharmacy Council information in intelligence gathering. Monitor the reporting status published by MHLW and use it for peer benchmarking.

5. Verification checklist

• □ Is the GVP system (organization, responsibilities, collection, assessment, measures) in place before the first shipment?
• □ Has a written information-transfer agreement been concluded between the foreign manufacturer and the D-MAH?
• □ Has an active information-collection mechanism toward the clinical side been established?
• □ Do the system documents distinguish the system itself (GVP Ordinance) from the reporting workflow (implementing rules and notifications)?
• □ Is the reporting duty-holder clearly identified as the MAH (Article 68-10, paragraph 1)?

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