Foreign Special Approval Holders and the Designated MAH in Japan

1. Key takeaways

The foreign special approval holder system allows an overseas manufacturer to hold the Japanese approval itself. The condition is that, at the time of application, the applicant appoints a Japanese marketing authorisation holder that holds the corresponding licence, known as the D-MAH. The value of this structure is stability of approval ownership: replacing the D-MAH requires only a notification within 30 days, rather than a transfer of the approval through succession as in the Japanese MAH model. The risk is equally clear: where the D-MAH position becomes vacant and no replacement is appointed, the approval may be rescinded, and no new approval may be granted for 3 years from the rescission.

• Article 23-2-17, paragraph 1 of the PMD Act lets the Minister grant approvals per product to overseas manufacturers exporting to Japan.
• The applicant must appoint a Japanese marketing authorisation holder holding the corresponding licence, which then carries the measures to prevent health and hygiene hazards.
• Changing the D-MAH requires notification to the Minister of Health, Labour and Welfare within 30 days under Article 23-2-18.
• Where the D-MAH position is vacant without replacement, the approval can be rescinded under Article 75-2-2, and re-grant can be refused for 3 years from the rescission date.
• The D-MAH must retain business records for 5 years and specified approval-related documents for 5 years from the date they cease to be used.

2. Legal basis

Article 23-2-17, paragraph 1 of the PMD Act provides that the Minister of Health, Labour and Welfare may, upon application by the manufacturer, grant an approval per product for medical devices manufactured abroad and exported to Japan. Article 23-2-17, paragraph 3 requires the applicant to appoint a Japanese marketing authorisation holder holding the licence for the corresponding product, which bears the measures to prevent the occurrence of health and hygiene hazards.

Article 23-2-17, paragraph 4 names the appointed party the designated marketing authorisation holder for foreign-manufactured medical devices and other products, the D-MAH, which may manufacture and market the approved product. Article 23-2-17, paragraph 5 applies the refusal grounds of Article 23-2-5, paragraph 2 mutatis mutandis, but expressly excludes the licence requirement among them.

Article 23-2-18 of the PMD Act requires notification to the Minister of Health, Labour and Welfare within 30 days when the D-MAH or its name and other particulars change. Article 75-2-2 provides that where the D-MAH position has become vacant and no replacement has been appointed, the approval may be rescinded, and that no new approval may be granted for 3 years from the date of rescission.

Article 114-74 of the Implementing Rules sets the compliance items for the D-MAH, including the retention of business records for 5 years, and the retention for 5 years from the date of last use of the approval particulars documents, copies of application data, report particulars documents and similar records. Form 54 of the MHLW forms is the notification form for changes to the appointed marketing authorisation holder or the foreign special approval holder. The system was introduced by Act No. 96 of 2022, published in December 2022, with the exact publication date to be confirmed against the official gazette and e-Gov Legislative Search. The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: what the system changes is the ownership of the approval, not the existence of holder duties. The overseas manufacturer acquires the position of holder of the approval itself, but the duty to take measures preventing the occurrence of hazards remains borne by the D-MAH in Japan. The D-MAH is therefore not a nominal role: its capability directly determines the real level of post-market compliance. Choosing a D-MAH purely on price or convenience while ignoring organisational depth transfers little of substance and leaves the structure fragile where it matters.

Insight 2: the record retention duty falls on the D-MAH, on a 5-year basis. Article 114-74 of the Implementing Rules requires the D-MAH to retain business records for 5 years, and to retain the approval particulars documents, copies of application data, copies of evaluation application data, report particulars documents and similar records of the foreign special approval holder for 5 years from the date they are no longer used. This means the D-MAH needs genuine document management capability, with controlled storage, defined retention and reliable retrieval over the full 5-year horizon.

Insight 3: the rescission risk and the 3-year bar hang over the structure. Article 75-2-2 provides that where the D-MAH position is vacant and no replacement is appointed, the approval may be rescinded, and under Article 23-2-17, paragraph 2 no new approval may be granted for 3 years from the rescission date. When GRZAN assists clients in designing this structure, a backup D-MAH is normally reserved in advance, precisely to avoid single-point dependency on one partner whose loss would put the whole approval at risk.

4. Practical recommendations

• Treat the D-MAH selection as a long-term partnership rather than a form-filing service, and verify the licence class, organisational capability and document management.
• Reserve a backup D-MAH so that a replacement can be appointed promptly if the primary partner develops a qualification or capability problem, avoiding the rescission risk.
• Complete change notifications within 30 days, using MHLW Form 54, and set internal triggers that fire whenever a change event occurs.
• Compare the transfer costs of the two structures: under the MAH-held model the approval moves through succession, while under the D-MAH model only a change notification is needed, and the difference in cost when changing partners is substantial.
• Audit the D-MAH record retention against Article 114-74 periodically, not only at onboarding.

5. Verification checklist

• □ Has the licence class of the proposed D-MAH been confirmed to cover the target product?
• □ Can the change notification be completed within 30 days under Article 23-2-18 of the PMD Act?
• □ Have the rescission risk of Article 75-2-2 and the 3-year re-application bar been assessed?
• □ Does the D-MAH have the 5-year record retention capability defined in Article 114-74 of the Implementing Rules?
• □ Has a backup D-MAH been reserved?

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