Foreign Manufacturer Certification under Article 23-2-23 of the Japanese PMD Act

1. Key takeaways

The foreign special approval holder system is not confined to the approval pathway. An overseas manufacturer that goes through the certification pathway can also obtain the certification itself, through an appointed Japanese marketing authorisation holder, under Article 23-2-23, paragraph 1 of the PMD Act. When the appointed party changes, notification must be given to the Registered Certification Body within 30 days under Article 23-3, paragraph 2. GRZAN places this pathway on the priority evaluation list for Chinese manufacturers of Class II devices and certifiable Class III devices.

• Article 23-2-23, paragraph 1 lets an overseas manufacturer obtain certification from a Registered Certification Body itself, through an appointed Japanese marketing authorisation holder holding the corresponding licence.
• Changes to the appointed party are notified to the Registered Certification Body within 30 days under Article 23-3, paragraph 2.
• Certification is implemented by Registered Certification Bodies under Article 23-2-13 of the PMD Act.
• The essential requirements and certification standards rest on Article 41, paragraph 3 and Article 42, paragraph 2 of the PMD Act.
• Notification of general medical devices, under Article 23-2-12, may only be filed by a Japanese marketing authorisation holder, so there is no self-holding space below Class II.
• The certification pathway mirrors the approval pathway in structure: overseas self-holding plus an appointed Japanese marketing authorisation holder.
• Change notifications on the certification pathway go to the Registered Certification Body, not to the ministry.

2. Legal basis

Article 23-2-23, paragraph 1 of the PMD Act provides that a person who manufactures medical devices in a foreign country and exports them to Japan may, by appointing a Japanese marketing authorisation holder holding the licence for the corresponding product, obtain certification from a Registered Certification Body in its own name. This provision mirrors, for the certification pathway, the self-holding mechanism that Article 23-2-17 provides for the approval pathway.

Article 23-3, paragraph 2 of the PMD Act requires notification to the Registered Certification Body within 30 days when the appointed marketing authorisation holder or other particulars change. Article 23-2-13 of the PMD Act provides that certification is implemented by Registered Certification Bodies. Article 41, paragraph 3 of the PMD Act grounds the essential requirements, and Article 42, paragraph 2 grounds the certification standards.

Article 23-2-12 of the PMD Act governs the notification of general medical devices, and such notification may be filed only by a Japanese marketing authorisation holder. An overseas manufacturer has no space to hold a notification in its own name at this tier. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: the approval and certification pathways are equally open to overseas manufacturers, but the notification pathway is not. The approval pathway has Article 23-2-17 and the certification pathway has Article 23-2-23, and the two provisions share the same structure: the overseas manufacturer holds the authorisation itself and appoints a Japanese marketing authorisation holder. The notification pathway, under Article 23-2-12, is different: only a Japanese marketing authorisation holder can file. The space for overseas self-holding therefore exists at Class II and above, and it does not exist at Class I. Portfolio planning should reflect this boundary from the outset rather than discovering it during registration.

Insight 2: on the certification pathway, the QMS investigation is implemented by the RCB. Unlike the approval pathway, where the investigation is implemented by the PMDA, the QMS conformity investigation of the manufacturer on the certification pathway is implemented by the Registered Certification Body. An overseas manufacturer preparing a certification application therefore has to manage two threads with the same body: the certification review and the QMS investigation. Aligning the preparation of both threads with a single RCB timetable avoids duplicated effort and scheduling mismatches.

Insight 3: the 30-day change notification goes to the Registered Certification Body, not to MHLW. Article 23-3, paragraph 2 designates the Registered Certification Body as the recipient of the change notification, in contrast to the approval pathway, where notification goes to the Minister of Health, Labour and Welfare. Internal processes need to distinguish these two reporting lines, because sending a certification-pathway change to the ministry, or an approval-pathway change to the RCB, creates avoidable compliance noise and delay.

4. Practical recommendations

• Give priority to evaluating self-holding for Class II and certifiable Class III devices, obtaining the certification through Article 23-2-23, paragraph 1 so that ownership of the authorisation stays stable.
• Separate the recipients of change notifications: certification changes go to the RCB, approval changes to the Ministry of Health, Labour and Welfare, with separate reminders for the two lines.
• Start the certification application and the QMS investigation together, submitting both to the same RCB to avoid scheduling mismatches.
• Do not pursue self-holding for Class I devices; the notification pathway offers no overseas self-holding space, so arrange them under the MAH model.
• Confirm that the appointed Japanese marketing authorisation holder licence class covers the target product before filing.
• Record the appointment particulars so that any later change event can be identified and notified without delay.
• Keep the certification review and QMS investigation document sets aligned, since the same RCB assesses both.
• Reflect the certification pathway structure in portfolio planning, so that notification-tier products are not pushed into a self-holding route that does not exist.

5. Verification checklist

• □ Has the applicability of Article 23-2-23, paragraph 1 to the product been confirmed?
• □ Does the licence class of the appointed Japanese marketing authorisation holder cover the target product?
• □ Can the change notification be completed within 30 days to the Registered Certification Body under Article 23-3, paragraph 2?
• □ Have the certification application and the QMS conformity investigation been submitted to the same RCB in step?
• □ Are Class I products arranged under the MAH model, without misuse of the self-holding pathway?

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