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What is Not a Medical Device?

Understanding exclusions is often as important as understanding the definition. Several common product categories are explicitly outside the scope of the Health Products (Medical Devices) Regulations 2010, or fall outside scope based on their intended purpose.

Explicitly excluded or separately regulated categories​

Therapeutic products​

Products that achieve their principal intended action by pharmacological, immunological, or metabolic means are regulated as therapeutic products under Part 3 of the Health Products Act, not as medical devices. This includes most medicines, vaccines, and biologics.

Where a device incorporates a pharmacological substance in a secondary role (e.g. a drug-eluting stent), it is generally regulated as a Class D medical device. See Borderline and Combination Products.

Health supplements​

Products regulated as health supplements (e.g. vitamins, minerals, nutritional products) fall under a separate regulatory pathway. A product that makes therapeutic or diagnostic claims, however, may be reclassified as a medical device or therapeutic product depending on those claims.

Traditional medicines and Chinese proprietary medicines​

Separately regulated under the Health Products Act. No overlap with the medical device pathway unless a product carries a medical device intended purpose.

Cosmetic products​

Products used solely to cleanse, perfume, change appearance, or maintain personal hygiene — without any medical or physiological claim — are regulated as cosmetics. The line is drawn by the manufacturer's intended purpose and label claims. A teeth whitening product claiming only cosmetic effect is a cosmetic; a product claiming to treat tooth sensitivity or disease is likely a medical device.

General laboratory equipment​

Equipment used for research or industrial purposes with no intended use on or with human specimens for diagnostic purposes falls outside scope. A laboratory centrifuge intended for general research is not a medical device; the same centrifuge sold specifically for processing human blood samples for diagnostic use may be.

Personal protective equipment (PPE)​

Standard PPE (gloves, gowns, face shields) sold for general occupational safety without medical claims is not regulated as a medical device. Surgical gloves, surgical drapes, and surgical masks that are supplied for use in a medical context and carry relevant intended purpose statements are medical devices.

Software — the carve-out for general purpose and administrative software​

Not all healthcare-related software is a medical device. Software is only within scope if it meets the intended purpose test described in the main definition.

Software that is generally not a medical device includes:

  • Administrative or workflow software (scheduling, billing, electronic health records that do not themselves perform diagnostic analysis);
  • General communication and messaging platforms;
  • Software that stores or displays data without providing clinical decision support;
  • General fitness and wellness apps that do not claim to diagnose, treat, or monitor a medical condition.

Software that is a medical device (SaMD) includes:

  • Software that analyses patient data to provide a diagnosis or recommend a treatment;
  • AI-powered imaging analysis tools that flag clinical findings;
  • Apps that calculate medication dosing based on patient parameters and clinical condition.

See Digital Health and SaMD for HSA's classification approach to software.

Using HSA's tools​

HSA provides two online tools to help determine product status and classification:

For genuinely borderline cases, HSA's Consultation Schemes (including the pre-submission product classification consultation) allow manufacturers and importers to seek HSA's view before committing to a regulatory pathway.

Official sources​