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Borderline & Combination Products

Borderline products​

A borderline product is one where it is unclear whether it qualifies as a medical device or falls under another regulatory category (drugs, cosmetics, food). The SFDA addresses borderline classification through guidance document MDS-G008 (Chapter 1).

If you are uncertain whether your product is a medical device, you should:

  1. Review the SFDA definition in Article 1 of the Medical Devices Law
  2. Apply the decision framework in MDS-G008
  3. Request a formal borderline determination via your AR through the GHAD portal

Combination products — device + medicinal substance​

A product that incorporates both a device component and a medicinal substance as an integral part is classified based on the principal mode of action:

  • If the device component is the principal action → regulated as a medical device (the medicinal component is accessory)
  • If the medicinal component is the principal action → regulated as a medicine by SFDA's Drug Sector

Examples of device-principal combination products: drug-eluting stents, antibiotic-loaded bone cement, insulin delivery pens with drug prefilled.

Annex XVI devices (non-medical purpose)​

Certain devices without a medical intended purpose are nonetheless regulated as medical devices by the SFDA, mirroring the EU MDR Annex XVI approach. These include aesthetic devices such as:

  • Contact lenses without corrective purpose
  • Lasers for skin resurfacing, hair removal, or tattoo removal
  • Body shaping and liposuction equipment
  • Non-invasive brain stimulation devices for non-medical use

These devices are classified and registered via MDMA like standard medical devices.

Further reading​