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Annex XVI Aesthetic Devices — SFDA Treatment

What are Annex XVI-type devices?​

In EU MDR terminology, Annex XVI refers to a list of devices that have no medical intended purpose but are regulated as medical devices because they present comparable risks to equivalent medical devices. The SFDA applies a similar concept under its Medical Devices Law and guidance document MDS-G008, Chapter 1.

Which devices does the SFDA regulate as medical devices without a medical purpose?​

The SFDA follows the approach established in MDS-G008, mirroring the EU MDR Annex XVI categories. Devices regulated as medical devices despite having no medical intended purpose include:

Device typeExample
Contact lenses without corrective purposeColoured cosmetic contact lenses
Laser or intense pulsed light (IPL) equipment for skin treatmentHair removal lasers, skin resurfacing devices
Equipment using electrical stimulation for non-medical useTranscranial stimulators marketed for wellness
Liposuction, lipolysis or lipoplasty equipmentBody-contouring devices
High-intensity electromagnetic radiation devicesNon-therapeutic energy-based body treatment devices
Dermal fillers and injectable aesthetic products (device component)Hyaluronic acid fillers for aesthetic augmentation
Brain stimulators for non-medical enhancementNeurostimulators for cognitive enhancement claims
Verify against MDS-G008

The SFDA's list in MDS-G008 may differ from the EU MDR Annex XVI list in scope or detail, and may be updated independently. Always verify the current SFDA guidance rather than assuming exact alignment.

Regulatory treatment​

Devices falling within the SFDA's scope under this category are:

  • Subject to MDMA requirement — they must be registered before market entry in KSA
  • Classified using the same classification rules as medical devices under MDS-REQ 1
  • Required to meet the Essential Principles of Safety and Performance
  • Subject to the same QMS, UDI, and post-market obligations as medical devices

Common misconceptions​

"My device is purely cosmetic — it's not regulated in Saudi Arabia." This is incorrect for devices in the categories above. Aesthetic and wellness devices using lasers, energy-based technologies, injectables, or body-shaping equipment are regulated as medical devices in Saudi Arabia and require MDMA.

"My device is sold as a beauty device, not a medical device." Marketing labelling does not determine regulatory classification. The SFDA assesses the device based on its characteristics and risks, not solely the manufacturer's marketing intent for non-medical purpose devices.

Borderline determination​

If you are uncertain whether your aesthetic or wellness device falls within the regulated scope in Saudi Arabia, request a formal borderline determination from the SFDA via your AR before commencing MDMA preparation. This avoids both unnecessary registration costs and the risk of marketing a device that should have been registered.

Further reading​