Special Device Types
Radiation-emitting devices
Devices that emit ionising or non-ionising radiation (X-ray systems, CT scanners, MRI, laser therapy devices, ultrasound equipment) are regulated as medical devices under MDMA and are subject to additional oversight by the SFDA's Radiation Sector. Manufacturers may need to comply with both medical device and radiation protection requirements.
Devices incorporating medicinal substances
Where a device incorporates a medicinal substance as an integral component and the device component is the principal action, the product is regulated as a medical device. The technical file must address the safety and performance of the medicinal component in addition to the device component. Consultation with both SFDA Medical Devices and Drug sectors may be advisable for novel combination products.
Custom-made devices
A custom-made device is manufactured specifically to meet the prescription of a duly qualified medical practitioner for a specific patient. Custom-made devices:
- Are exempt from MDMA but must comply with applicable Essential Principles
- The manufacturer must maintain technical documentation demonstrating compliance
- Cannot be mass-produced under a "custom-made" label
Novel and innovative devices
The SFDA may authorise exemptions from specific MDMA requirements for novel or innovative devices where full technical documentation is not yet available. Such exemptions are granted at SFDA discretion and require a formal request via GHAD.
Single-use and reprocessed devices
Single-use devices (SUDs) must be labelled as such. Reprocessing of single-use devices in healthcare facilities is a separate compliance matter — the original manufacturer's SUD designation does not preclude third-party reprocessing, but the reprocessor assumes the manufacturer's obligations.
Export-only devices and MDIL
Devices not intended for the Saudi market but manufactured or held in KSA for export only may be exempt from MDMA. The SFDA also provides a Medical Device Importing License (MDIL) for certain exempted device categories (e.g. research samples, demonstration devices, semi-finished products for local manufacture). The list of MDIL-eligible categories is published on the SFDA website.