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Ministerial Ordinance on Advertising Standards

Advertising restrictions for medical devices are established in PMD Act Articles 66–68 and elaborated in MHLW notifications on advertising standards. Japan does not have a single "advertising ordinance" — the rules emerge from the combination of the PMD Act provisions and the MHLW notification guidance.

Official source

MHLW advertising guidance (Japanese)

The three criteria for prohibited advertising​

MHLW applies a three-part test for identifying prohibited medical device advertising. Advertising is prohibited when all three conditions are met:

  1. Named product — the communication refers to a specific device or brand
  2. Identified audience — the communication is directed at identifiable recipients (healthcare professionals, consumers, or the general public)
  3. Promotional intent — the communication is designed to promote the purchase or use of the product

Prohibited advertising practices​

Unapproved claims — any claim about an indication, intended use, or performance not included in the Shonin or Ninsho is prohibited. This includes off-label use suggestions.

Exaggerated efficacy or safety claims — representations that overstate a device's benefits or understate its risks.

False comparisons — claiming superiority over competitor products without evidence.

Advertising before regulatory clearance — promoting a device to potential purchasers before the required Shonin, Ninsho, or Todokede is obtained.

Advertising to the general public for prescription-only equivalent devices — devices that can only be used under medical supervision may have restrictions on consumer-directed advertising.

Enforcement​

PMD Act advertising violations are enforced by:

  • MHLW at the national level (for systematic or serious violations)
  • Prefectural governments (for local advertising violations)

Enforcement tools include warnings, orders to cease advertising, and in serious cases, penalties under the PMD Act. MHLW actively monitors both print and digital advertising, including social media and healthcare provider portals.