QMS Conformity Investigation in Japan: Four Types and the Five-Year Cycle

1. Key takeaways

The Japanese QMS conformity investigation is bound to the product, not merely to the factory, and it comes in four types: the pre-approval investigation, the pre-approval investigation for partial change approvals, the periodic investigation, and the additional investigation. The periodic investigation runs at intervals of no more than 5 years from the date of approval. GRZAN reminds readers that even where the product approval itself remains valid indefinitely, an interruption in QMS investigation status directly affects the ability to keep selling.

• Four investigation types exist, each triggered by a different event: new application, partial change, the 5-year cycle, and regulatory need.
• The periodic cycle is fixed by Article 37-21 of the Implementing Order: no more than 5 years from the approval date.
• Suitable implementation of manufacturing management and quality management is a condition of approval under Article 23-2-5, paragraph 2 of the PMD Act.
• The investigating body depends on the pathway: the PMDA, or a Registered Certification Body for certifiable Class II and III devices.
• Prefectural fee examples for the conformity investigation application at approval show 48,800 yen for the sterilisation category, 28,700 yen for the general category, and 13,300 yen for the packaging, labelling and storage category.
• A lapse in investigation status can leave an approval formally valid while the conditions for relying on it have fallen away.
• The investigating body should be confirmed at the application stage, since it determines the scheduling counterpart and the communication channel.

2. Legal basis

Article 23-2-5, paragraph 7 of the PMD Act provides the basis for the QMS conformity investigation. Article 37-21 of the Implementing Order sets the cycle of the periodic conformity investigation at intervals of no more than 5 years from the date of approval. Article 23-2-5, paragraph 2 of the PMD Act makes the suitable implementation of manufacturing management and quality management a condition of approval, which is what links the investigation to continued market presence.

On who conducts the investigation, the allocation depends on the pathway and the classification. Under the approval pathway the investigation is implemented by the PMDA, while for Class II and Class III devices for which certification standards exist it is implemented by a Registered Certification Body. The precise allocation follows the classification and the pathway of the product in question.

Fees for prefectural filings are charged under the fee ordinances of the prefectures. Published examples for the medical device conformity investigation application at the time of approval show 48,800 yen for the sterilisation category, 28,700 yen for the general category, and 13,300 yen for the packaging, labelling and storage category. These are public examples, and the applicable amount must be confirmed against the current ordinance of the prefecture concerned. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: the investigation type is determined by the triggering event, not by a single calendar. The pre-approval investigation is triggered by a new application; the pre-approval investigation for a partial change approval is triggered by events such as the addition of facilities or a change of sterilisation method; the periodic investigation is triggered by the 5-year cycle; and the additional investigation is triggered by regulatory need. Because the four triggers differ, a company needs separate monitoring points for each. A calendar that tracks only the 5-year periodic cycle will miss the change-driven and regulator-driven triggers entirely.

Insight 2: the investigation covers the system plus the manufacturing sites, and it is bound to the product. The investigation covers both the quality and safety management system of the marketing authorisation holder and the manufacturing management and quality management of the manufacturer, and it checks the registered manufacturing sites. This means that changing a manufacturing site or adding a contractor can each trigger a new investigation requirement. The binding to the product is what makes lapses so consequential: the approval may still exist on paper while the conditions for relying on it have fallen away.

Insight 3: the investigating body follows the pathway and classification, and this shapes the whole interface. For Class II and Class III devices for which certification standards exist, the investigation is implemented by a Registered Certification Body; for the remainder, including Class IV devices and new medical devices, it is implemented by the PMDA. The allocation determines which counterpart is scheduled, which documents are expected in which format, and how communication runs. It should be confirmed at the application stage, not discovered mid-project.

4. Practical recommendations

• Build a trigger monitoring table for the four investigation types, with a named owner for each trigger: application, change, periodic cycle and regulatory request.
• Set the periodic investigation reminder on the 5-year cycle, and plan to start preparation about 6 months ahead. This is a practical estimate, not a statutory figure.
• Update the FMR before pursuing the product change when a manufacturing site changes; reversing the order leaves the investigation unable to cover the actual production conditions.
• Map the investigation documentation one-to-one against the QMS ordinance, with particular attention to the evidence for the Japanese additional requirements in Chapter 3.
• Confirm early whether the PMDA or a Registered Certification Body will conduct the investigation, and organise the interface accordingly.
• Treat site additions and sterilisation method changes as investigation triggers, not only as product change events.

5. Verification checklist

• □ Has a trigger monitoring table for the four investigation types been built?
• □ Is the periodic investigation reminder set on the 5-year cycle of Article 37-21 of the Implementing Order?
• □ Has the investigating body for the product, the PMDA or a Registered Certification Body, been confirmed?
• □ Are site changes executed in the order of updating the FMR first, then changing the product?
• □ Does the investigation documentation cover the Japanese additional requirements of Chapter 3 of the QMS ordinance?

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