Manufacturing and Marketing, Import and License-Holding Obligations

1. Key takeaways

Under Japanese law, the concept of manufacturing and marketing covers both producing and selling one’s own products and importing and then selling them. Consequently, any imported medical device sold in Japan must have a Japanese entity holding the manufacturing and marketing business license that carries the license-holding obligations, and an overseas manufacturer cannot stand aside on the ground that it is merely the exporting party. The only softening mechanism is for the overseas manufacturer to hold the approval itself as a foreign special approval holder, yet even then it must appoint a Japanese manufacturing and marketing business operator, so the presence of a local license-holding entity is never optional. Commercial teams should internalize this point before contract drafting begins, because every distribution structure built on the contrary assumption will need to be rebuilt once the licensing analysis lands.

• The statutory definition of manufacturing and marketing lists self-production and import side by side as sources.
• Providing device programs through telecommunications lines is also captured by the definition.
• The foreign special approval holder mechanism changes who holds the approval, not whether a Japanese entity is required.

2. Legal basis

The provisions below define the scope of the manufacturing and marketing concept and the licensing obligations that flow from it. The definition is the pivot: everything the definition captures triggers the obligation to hold a license.

1. PMD Act Article 2, Paragraph 13: the definition of manufacturing and marketing, covering the sale, rental, or gifting of drugs, quasi-drugs, cosmetics, medical devices, or regenerative medicine products after manufacturing (including commissioned manufacturing, but excluding manufacturing undertaken as a contract acceptor) or after import, as well as providing medical device programs through telecommunications lines.
2. PMD Act Article 23-2, Paragraph 1: a party intending to engage in the manufacturing and marketing business must obtain a license from the prefectural governor to whom the authority has been granted by the Minister of Health, Labour and Welfare.
3. PMD Act Article 23-2-5, Paragraph 2: among the grounds for refusal of approval is that the applicant has not obtained the manufacturing and marketing business license for the relevant item.
4. PMD Act Article 23-2-17: the foreign special approval holder system, under which an overseas manufacturer may itself obtain approval after appointing a Japanese manufacturing and marketing business operator.
5. PMD Act Article 2, Paragraphs 5 through 7: the correspondence between classification and license types.
6. The current statute: Act No. 145 of 1960 (Showa 35).

3. Expert insights

Insight one: the definition names two modes of acquisition, with import placed on a par with self-production.

Article 2, Paragraph 13 lists self-manufacture and import together as the antecedent sources of manufacturing and marketing. Japanese legislation treats import as an extension of the manufacturing stage rather than as a distribution stage independent of manufacturing. This is the fundamental difference between Japan and some other markets in how license-holding obligations are allocated, and it is the reason a foreign exporter cannot characterise itself as a mere supplier outside the regulatory perimeter. The allocation follows the statutory definition, not the wording of the supply contract between the parties.

Insight two: providing programs through telecommunications lines is also written into manufacturing and marketing.

Article 2, Paragraph 13 brings the provision of medical device programs through a network within manufacturing and marketing. This means that a business model in which software as a medical device is delivered as a cloud service triggers license-holding obligations in Japan in the same way as a boxed product. There is no room for the argument that only providing a software service does not count as selling, and subscription models inherit the full obligation set. The delivery channel is irrelevant to the analysis; what matters is that the program is provided as part of the business of dealing in the device.

Insight three: the foreign special approval holder changes who holds the approval, not the need for a Japanese entity.

Article 23-2-17 allows an overseas manufacturer to hold an approval itself, but it mandates the appointment of a Japanese manufacturing and marketing business operator holding the relevant license, which carries the obligation to take measures to prevent harm to health and hygiene. The institution therefore changes the attribution of the approval, not the existence of the license-holding obligation, and the appointed operator remains on the hook for the measures just described.

4. Practical recommendations

• Design the license-holding structure before commercial negotiations. Fix the MAH or D-MAH model first and discuss distribution terms afterwards, so that a change of distributor does not drag the attribution of the approval along with it.
• Treat software as a medical device projects as manufacturing and marketing. Cloud delivery, subscriptions, and per-use charging all need to be built into the license-holding and vigilance design in advance.
• Verify the coverage of the Japanese entity’s license types. The manufacturing and marketing business license is divided into the first, second, and third types, which must match the classification of the target items.
• Stipulate the attribution of the approval and the change mechanism in the agreement. In particular, under the MAH model the approval can only be transferred by succession, which differs markedly in efficiency from the change notification available under the D-MAH model.

5. Verification checklist

• □ Has the Japanese license-holding entity for this project and its manufacturing and marketing business license type been confirmed?
• □ For software as a medical device projects, has the provision through telecommunications lines been assessed against the manufacturing and marketing obligations?
• □ For projects using the foreign special approval holder route, has the designated manufacturing and marketing business operator been determined?
• □ Does the distribution agreement clearly state the attribution of the approval and the mechanism for changing entities?
• □ Has the understanding that the overseas exporting party bears no obligations under Japanese law been ruled out?

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 manages PMDA submissions across Shonin/Todokede routes, coordinates J-QMS conformity, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com