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What is Not a Medical Device?

Not every health-related product falls under the PMD Act as a medical device. Products that do not meet the definition in Article 2 — or are not listed in the Cabinet Order — are not regulated as medical devices, even if they are used in healthcare settings.

Quasi-drugs (医薬部外品)​

Quasi-drugs (iyakubu-gaihin) are a Japan-specific product category defined in PMD Act Article 2, Paragraph 2. They include products intended for mild physiological effects such as hair tonics, skin conditioners, deodorants, and certain disinfectants. They are not drugs and not medical devices, but are still subject to MHLW licensing requirements.

Products that may look like medical devices — certain adhesive bandages, for example — may instead be classified as quasi-drugs. The intended use and the Cabinet Order listing determine the classification.

Cosmetics​

Cosmetics are regulated under the PMD Act Article 2, Paragraph 3 as products intended to clean, beautify, or maintain the skin, hair, or teeth. They are subject to a separate cosmetics licensing regime administered by MHLW/prefectural governments. A product with both cosmetic and medical device claims requires careful evaluation of its primary intended purpose.

General consumer products with health claims​

Products sold with general wellness claims (improving sleep, promoting relaxation) but without specific medical device intended uses are not regulated under the PMD Act. However, MHLW enforces restrictions on what health and functional claims can legally be made. Products that cross into disease diagnosis, treatment, or prevention claims are likely to require medical device regulation.

Research-use-only (RUO) products​

Products explicitly labelled and sold solely for research purposes, with no diagnostic or therapeutic claims, are generally not classified as medical devices. However, MHLW has issued guidance cautioning that RUO labelling does not automatically exclude a product if it is in fact being used clinically.

How PMDA handles borderline determinations​

If the regulatory status of a product is genuinely unclear, the manufacturer or MAH can request a borderline determination from PMDA through a formal consultation process. PMDA will assess:

  1. The intended use as described in labelling and promotional materials
  2. The physiological effect of the product
  3. Whether the product falls within a Cabinet Order category

PMDA's determination is not legally binding in the sense of a formal MHLW approval, but it provides a strong indication of how a formal application would be assessed. Getting an early determination avoids the risk of marketing a product that later requires regulatory action.