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Advertising and Promotional Claims

PMD Act advertising restrictions​

The PMD Act (Articles 66–68) places significant restrictions on how medical devices may be advertised in Japan. These restrictions apply to all parties — the MAH, importers, distributors, and agents.

What constitutes "advertising" under the PMD Act​

MHLW has issued guidance on what constitutes regulated advertising. It includes:

  • Published advertisements (print, digital, TV, radio)
  • Product brochures and promotional materials distributed to healthcare professionals
  • Website content promoting a specific device
  • Scientific symposia and presentations that include product promotion
  • Direct mail to healthcare institutions

Note that the advertising restrictions also apply to digital channels — websites, social media, and email marketing materials promoting devices for specific uses.

Claims that are prohibited​

Unapproved claims. Claims about indications, contraindications, or intended uses that are not part of the approved Shonin or Ninsho labelling are prohibited.

Exaggerated efficacy claims. Claims that the device is superior to alternatives without adequate evidence are prohibited.

False safety claims. Any claim that creates a false impression of safety is prohibited.

Advertising unapproved devices. Advertising a device before it has received the required Shonin, Ninsho, or Todokede is prohibited.

MAH responsibility for distributor advertising​

The MAH is responsible for ensuring that distributors and agents do not make advertising claims that violate the PMD Act. MAHs should include advertising compliance provisions in distribution agreements and monitor distributor communications.

Enforcement​

PMD Act advertising violations are enforced by MHLW and prefectural governments. Violations can result in warnings, orders to cease advertising, and in serious cases, penalties. MHLW actively monitors device advertising, including online content.