MDSAP in Japan: Additional Requirements and What Acceptance Does Not Replace

1. Key takeaways

An MDSAP audit report can be used to reduce the investigation burden in Japan, provided that it covers all the additional requirements of the Japanese QMS ordinance. It is not, however, an automatic pass of the conformity investigation: the PMDA and Registered Certification Bodies retain the discretion to require an on-site verification. GRZAN recommends positioning MDSAP as an investment that lowers the probability of on-site verification, not as a certificate of exemption from inspection.

• MDSAP acceptance depends on the audit covering the full set of Japanese additional requirements in the QMS ordinance.
• The Japanese module of the MDSAP audit programme requires registered sites to transmit promptly to the marketing authorisation holder the events defined in Article 228-20 of the Implementing Rules.
• Those events include serious incidents at home and abroad, unknown non-serious incidents occurring in Japan, foreign measures against equivalent devices, and study reports indicating serious disease or reduced effectiveness.
• MDSAP does not exempt the site from Foreign Manufacturer Registration, which is a separate obligation under Article 23-2-4, paragraph 1 of the PMD Act, on a 5-year cycle.
• The discretion to require on-site verification remains with the reviewing body, so MDSAP lowers probability but never removes the possibility.
• Preparation for the MDSAP audit should focus on the upward reporting interface to the licensed entity and the records that evidence it.
• MDSAP and the Japanese investigation run on separate 5-year rhythms that need to be deliberately aligned.

2. Legal basis

The QMS ordinance, MHLW Ordinance No. 169 of 2004, published on December 17, 2004, sets the standards for manufacturing management and quality management, including the additional requirements specific to Japan in Chapter 3 and beyond. These additional requirements are the portion that an MDSAP audit must cover for the report to serve its burden-reducing purpose in Japan.

Article 23-2-5, paragraph 7 of the PMD Act governs the QMS conformity investigation, and the investigation methods include both document-based investigation and on-site investigation. Article 37-21 of the Implementing Order fixes the periodic conformity investigation cycle at intervals of no more than 5 years. Article 23-2-4, paragraph 1 of the PMD Act establishes Foreign Manufacturer Registration, and MDSAP does not remove that registration obligation.

The Japanese additional requirements in the MDSAP audit programme oblige the relevant manufacturing site to transmit promptly to the marketing authorisation holder the events defined in Article 228-20 of the Implementing Rules. These include serious incidents, whether domestic or foreign, that could lead to health damage; non-serious incidents of a kind unknown domestically that have occurred in Japan; measures taken by foreign authorities against equivalent devices to prevent public health hazards; and study reports indicating serious disease or a decline in effectiveness. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: the Japanese additional requirements concentrate on the interface with the licensed entity. The Japanese module of the MDSAP audit programme requires the registered manufacturing site to pass promptly to the marketing authorisation holder the events defined in Article 228-20 of the Implementing Rules: serious incidents capable of leading to health damage, whether occurring in Japan or abroad; non-serious incidents of kinds not previously known domestically; measures taken by foreign authorities against equivalent devices, such as suspension of manufacture, import or sale, recalls and withdrawals; and study reports indicating serious disease or a decline in effectiveness. These are, at bottom, upward reporting interfaces, and they have no counterpart in ISO 13485. An audit that does not evidence this interface does not deliver the Japanese benefit.

Insight 2: MDSAP does not exempt the site from Foreign Manufacturer Registration. The registration obligation derives from Article 23-2-4, paragraph 1 of the PMD Act and stands independently of the quality system audit. Holding an MDSAP report does not substitute for FMR registration, and it does not alter the management requirements of the 5-year validity period. The two obligations run on separate tracks and need separate tracking, because the expiry of one does not signal anything about the other.

Insight 3: the discretion to verify on site stays with the reviewing body. For high-risk products, newly registered sites, or cases where the document investigation raises questions, an on-site verification can still be demanded. What MDSAP reduces is the probability of such a request, not the possibility itself. Planning that assumes no site visit will ever happen is therefore inconsistent with the way the discretion actually operates, and the sensible posture is to remain visit-ready even with an MDSAP report in hand.

4. Practical recommendations

• Complete the system remediation for the Japanese additional requirements before the MDSAP audit, focusing on the reporting interface towards the licensed entity and its records.
• Run FMR and MDSAP in parallel and never treat one as replacing the other, with the two timelines scheduled separately.
• Keep a contingency plan for on-site verification, reserving document retrieval, translation support and on-site accompaniment in the plan.
• Synchronise the MDSAP audit cycle with the Japanese investigation status on the 5-year cycle, so that the two periods do not drift apart.
• Avoid presenting MDSAP internally or externally as exemption from inspection, since the discretion of the reviewing body remains.
• Evidence the Article 228-20 reporting interface in the audit records, since its absence undermines the Japanese benefit of the report.

5. Verification checklist

• □ Does the quality system cover the additional requirements of the Japanese MDSAP module, namely the reporting interface to the licensed entity?
• □ Has it been confirmed that MDSAP does not exempt the site from Foreign Manufacturer Registration under Article 23-2-4, paragraph 1 of the PMD Act?
• □ Is the contingency plan for on-site verification, covering documents, translation and accompaniment, in place?
• □ Are the MDSAP audit cycle and the Japanese periodic investigation cycle aligned?
• □ Has the use of exemption-from-inspection language about MDSAP been avoided?

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 coordinates In-Country Representative arrangements, marketing authorisation holder duties, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com