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Licensed MAH (Kannin) for Overseas Manufacturers

JP-unique

The Kannin (管理) model — where a Japan-based third-party company acts as MAH on behalf of an overseas manufacturer — is the most common route for foreign companies entering the Japanese device market. The term "Kannin" refers to the managed/commissioned nature of the MAH arrangement.

How the Kannin arrangement works​

In a Kannin arrangement:

  1. The overseas manufacturer retains technical and commercial ownership of the device and is responsible for manufacturing
  2. The Kannin MAH (Japan company) holds the MAH licence and the Shonin/Ninsho in its own name
  3. A formal contract between the two parties defines each party's responsibilities
  4. The Kannin MAH fulfils all Japan regulatory obligations (filing, reporting, surveillance) on behalf of the overseas manufacturer

From MHLW's perspective, the Kannin MAH is the regulated entity — all regulatory communications are addressed to the Kannin MAH.

Contractual obligations​

The contract between the overseas manufacturer and the Kannin MAH must cover:

  • Clear statement of responsibilities for each party (manufacturing, regulatory filings, post-market surveillance, adverse event reporting)
  • Information flow obligations — the manufacturer must promptly notify the MAH of adverse events, safety information, and planned device changes globally
  • Data rights — who owns the approval dossier, and what happens if the relationship ends
  • Liability allocation
  • Term and termination provisions, including what happens to the approval on termination
  • Financial terms (MAH fees, regulatory submission costs)

What happens to the approval when the Kannin relationship ends​

If the overseas manufacturer and Kannin MAH part ways, the approval must be transferred to a new MAH before the termination takes effect — or the approval lapses. This transfer process takes time and planning. Poor management of Kannin transitions is a common cause of market access gaps in Japan.

Common Kannin service providers​

Specialist Kannin MAH companies exist in Japan offering regulatory, QMS, and post-market surveillance services to overseas manufacturers. Law firms and regulatory consulting companies also offer MAH services. Selection should be based on scope, expertise in the relevant device categories, and financial stability.