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What is Not a Medical Device?

Not all healthcare or health-adjacent products are regulated as medical devices by the SFDA. Understanding the boundary is important to avoid unnecessary MDMA applications — or, conversely, to ensure your product is not inadvertently placed on the market without required authorization.

Products excluded from the medical device definition​

The following categories are generally not regulated as medical devices under the Medical Devices Law:

Medicinal products and pharmaceuticals​

Products whose principal intended action is pharmacological, immunological, or metabolic are regulated as medicinal products (drugs) by the SFDA's Drug Sector — not as medical devices. This includes medicines, vaccines, and gene therapies.

Combination products

A device that incorporates a medicinal substance as an integral part (e.g. a drug-eluting stent) is regulated as a medical device if the device component is the principal action. Products where the medicinal component is the principal action are regulated as medicines. See Devices Incorporating Medicinal Substances for details.

Cosmetics​

Products intended solely for cleansing, perfuming, altering appearance, or protecting the human body — without any medical intended purpose — are regulated under cosmetics regulations, not the Medical Devices Law.

Food and dietary supplements​

Nutritional products, dietary supplements, and functional foods are regulated under SFDA's Food Sector, not the Medical Devices Sector.

General laboratory equipment​

Instruments used in research or industrial settings without any specific human diagnostic or therapeutic purpose are not medical devices (e.g. general laboratory centrifuges used purely for research).

Personal protective equipment (PPE) — general purpose​

PPE such as safety gloves or dust masks for occupational protection, where there is no medical intended purpose, is not regulated as a medical device.

COVID-era PPE

Medical-grade PPE (e.g. surgical masks, medical gloves, protective gowns for clinical settings) is regulated as a medical device and requires MDMA.

Non-intended-purpose software and IT systems​

General-purpose software — hospital administration tools, electronic health record platforms not performing diagnostic analysis, accounting systems — does not qualify as a medical device. Only software with a specific medical intended purpose qualifies. See Software as a Medical Device.

Borderline cases​

When it is unclear whether a product qualifies as a medical device, the SFDA should be contacted via the Authorized Representative (AR) for a borderline determination before an MDMA application is submitted. The SFDA may also provide formal guidance in response to queries submitted through the GHAD portal.

Common borderline areas include:

  • Wellness devices (fitness trackers, sleep monitors) — may or may not qualify depending on intended purpose and claims made
  • Hospital furniture and patient handling equipment — not devices unless they serve a specific medical function
  • In vitro tests sold to general consumers — may qualify as IVDs depending on intended use

Practical guidance​

When assessing whether a product is a medical device:

  1. Review the manufacturer's intended purpose as stated on labelling, IFU, and marketing materials
  2. Apply the SFDA definition in Article 1 of the Medical Devices Law
  3. Consider whether the principal action is pharmacological, immunological, or metabolic (if so, likely a drug not a device)
  4. Consult MDS-G008 for borderline classification guidance
  5. If still uncertain, contact the SFDA via your AR

Further reading​