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Distributors and Retailers

Distributors and retailers of medical devices in Japan must comply with PMD Act requirements relating to business licensing, record-keeping, and reporting.

Distribution business licence​

Any business that sells medical devices to other businesses (wholesalers) or directly to healthcare providers must hold a distribution business licence (販売業許可 — hanbai gyō kyoka) or registration, depending on the device class. These are issued by prefectural governments.

The licensing requirements differ by device class:

  • Class III and IV — specific business licence required with higher requirements
  • Class II — distribution licence required
  • Class I — registration (届出) rather than full licence

Record-keeping obligations​

Distributors must maintain records of purchases and sales of medical devices for a minimum period specified in MHLW notifications. These records must be available for inspection by prefectural government inspectors.

Maintenance and repair​

Entities that repair medical devices must hold a repair business licence if the repair activity falls within the definition in PMD Act Article 40-2. Unlicensed repair of medical devices is a PMD Act violation.

Advertising restrictions​

Distributors are prohibited from advertising medical devices in ways that exceed the claims in the approved product labelling, or in ways that make false or misleading representations about safety and efficacy. The PMD Act's advertising provisions (Articles 66–68) apply to all parties in the supply chain, not only the MAH.