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Eligibility β€” Japan Domicile Requirement

JP-unique

MAH applicants must have a principal office in Japan. Foreign companies without a Japan business presence cannot hold an MAH licence directly, even through a subsidiary established solely for the purpose.

What the domicile requirement means in practice​

"Japan domicile" for MAH licence purposes means:

  • A registered corporate entity in Japan (ζ ͺ式会瀾, 合同会瀾, or other corporate form registered with the Japanese Legal Affairs Bureau)
  • A physical office address in Japan where business is conducted β€” not a virtual office or mail forwarding address
  • Sufficient organisational capability at the Japan office to fulfil MAH obligations (staffing, systems, records)

A foreign company cannot hold an MAH licence in its own name. Only a Japan-registered entity can corporate apply; however, a foreign company may apply jointly with a Japan-domiciled entity, or may apply through a Japan-registered subsidiary.

Options for overseas manufacturers​

Option 1 β€” Establish a Japan subsidiary. The overseas manufacturer incorporates a wholly or partially owned subsidiary in Japan. The subsidiary applies for and holds the MAH licence. The subsidiary is fully controlled by the parent but operates as a Japan legal entity.

  • Advantages: full control, aligned incentives, builds Japan regulatory capability
  • Disadvantages: incorporation costs, time to establish, requirement for Japan-based staffing

Option 2 β€” Contract with a Kannin MAH service company. A Japan-based third-party specialist company acts as the MAH on behalf of the overseas manufacturer.

  • Advantages: faster market access, lower fixed costs, immediate access to established regulatory expertise
  • Disadvantages: less direct control, contractual relationship risk, ongoing fees, changing MAH later requires a formal transfer process

Option 3 β€” Use an existing Japan distribution partner as MAH. A Japan distributor who already holds an MAH licence can add the overseas manufacturer's product to its licence.

  • Advantages: leverages existing Japan business relationship
  • Disadvantages: distributor's commercial interests and regulatory obligations may not always align; transferring the approval later if the distribution relationship ends is complex

Setting up a Japan legal entity β€” key considerations​

  • Allow 2–4 months for incorporation and staffing
  • The Responsible Technical Officer must meet MHLW qualification requirements
  • The MAH licence application to the prefectural government takes approximately 1–3 months after submission

The subsidiary must have a physical Japan office and Japan-based staff who are capable of executing MAH responsibilities. A subsidiary with only virtual office space or minimal Japan staffing may not satisfy regulatory expectations, and MHLW may request evidence of actual operational capacity during licence application review.