Japan Marketing Authorisation Licence Classes: Type 1, Type 2 and Type 3

1. Key takeaways

The manufacturing and marketing business licence is the entry threshold for any licensed entity in the Japanese medical device system. It is granted by class according to the risk of the devices handled, and in this guide the classes are referred to as Type 1, Type 2 and Type 3, corresponding to highly controlled, controlled and general medical devices. The licensing authority is the prefectural governor, who exercises the affairs delegated by the Minister of Health, Labour and Welfare. GRZAN reminds readers that the licence class must cover the classification of the target device: this is the first screening condition when selecting a D-MAH, and it is a qualification that foreign manufacturers cannot hold on their own account.

• Licence classes follow the risk of the devices handled, not the size or status of the company.
• The prefectural governor is the licensing authority, and fees are charged under each prefecture’s fee ordinance.
• Published prefectural examples show Type 1 licence application at 149,800 yen, Type 2 at 131,600 yen and Type 3 at 95,200 yen, with renewals at 140,000, 116,800 and 74,700 yen respectively.
• Lack of the required licence is a statutory ground for refusing approval, so licence coverage sits upstream of every product approval.
• Foreign manufacturers cannot hold this licence, but they can hold approvals themselves through the foreign special approval holder route, in which the licence requirement is expressly excluded.
• Licences carry a renewal cycle, and missing a renewal directly affects the continuity of the products covered.

2. Legal basis

Article 23-2, paragraph 1 of the PMD Act provides that a person who intends to engage in the manufacturing and marketing business must obtain a licence from the prefectural governor. This is the founding provision for the entire licensed entity structure described in this section.

Article 2, paragraphs 5 to 7 of the PMD Act establish the classification of devices into general, controlled and highly controlled medical devices. This classification corresponds to the licence classes, which is why the licence class of a candidate partner must be checked against the classification of the device in question.

Article 114-2 of the Implementing Rules sets out the application forms and the required particulars for manufacturing and marketing business licence applications. Article 23-2-5, paragraph 2 of the PMD Act lists the ground for refusing approval, which includes the case where the applicant has not obtained the relevant licence.

Fees are charged under the fee ordinances of the individual prefectures. Published examples show a Type 1 manufacturing and marketing business licence application at 149,800 yen, Type 2 at 131,600 yen and Type 3 at 95,200 yen, and renewal applications at 140,000, 116,800 and 74,700 yen respectively. These are public examples only: the amount actually payable must be confirmed against the current ordinance of the prefecture where the application is filed.

The current statutory basis of the regime is Act No. 145 of 1960, as amended.

3. Expert insights

Insight 1: licence classes are tied to device classification, not to enterprise status. The three classes answer the question of what risk level of devices the holder may handle. They are not a ranking of corporate capability. A single company may hold several classes at once, or may hold only the Type 3 licence and focus on general medical devices. For this reason, the core verification point when selecting a D-MAH is not how impressive the partner looks on paper, but whether its licence class covers the classification of the specific product. A partner with an extensive portfolio but the wrong licence class cannot serve as the licensed entity for the device at hand.

Insight 2: the licensing authority sits at the prefecture, and fees follow local ordinances. Manufacturing and marketing business licences are issued by prefectural governors, and the fees are charged under the fee ordinance of each prefecture. Amounts therefore differ from one filing location to another. GRZAN recommends that budgeting be based on the current ordinance of the actual prefecture of application, rather than on figures copied from another jurisdiction or from older materials. Treating prefectural fee data as transferable between prefectures is a common and avoidable budgeting error.

Insight 3: the licence is a common prerequisite for approval and certification, yet foreign special approval holders are carved out. Article 23-2-5, paragraph 2 lists the absence of a licence among the grounds for refusing approval. However, when this refusal ground is applied mutatis mutandis through Article 23-2-17, paragraph 5, the licence requirement is expressly excluded. This exclusion is precisely the technical mechanism that allows an overseas manufacturer to hold an approval in its own name without holding a Japanese manufacturing and marketing business licence. Understanding this carve-out is essential for designing a structure in which approval ownership stays stable.

4. Practical recommendations

• Screen candidate D-MAHs first on licence class coverage. Record the licence class, licence number and licence date in the due diligence checklist for every candidate.
• Verify fees against the fee ordinance of the actual prefecture of application. Treat the amounts as a separate budget line and refresh the check whenever the ordinance changes.
• Evaluate the self-holding path in parallel. If stable ownership of the approval is a priority, consider a structure combining a foreign special approval holder with a D-MAH arrangement.
• Build licence renewal into the compliance calendar. Licences run on a renewal cycle, and a lapse affects the continuity of every product that depends on the licence.
• Keep the licence documentation current. Application forms and particulars should follow the formats of Article 114-2 of the Implementing Rules.

5. Verification checklist

• □ Does the licence class of each candidate licensed entity cover the classification of the target device?
• □ Have the fees been checked against the current fee ordinance of the actual prefecture of application?
• □ For self-holding structures, has the exclusion of the licence requirement under Article 23-2-17, paragraph 5 been confirmed?
• □ Has licence renewal been entered in the compliance calendar with an advance reminder?
• □ Do the application documents follow the formats under Article 114-2 of the Implementing Rules?

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