Article 23 of the Saudi Medical Devices Law

This article restricts the dispensing of one specific type of device and supply: those classified as high-risk under the classification system.

The rule: these devices may not be dispensed for use outside the health care provider's establishment without a medical prescription.

To understand the scope of the rule:

• The restriction covers high-risk devices only, not all medical devices.
• The restriction covers dispensing for use outside the health care establishment, for example where a patient uses it at home.
• The required condition is a medical prescription.
• The Authority issues a list of these devices, so whether a particular device is covered is learned by referring to this list.

The article is linked to Article 21, which requires the manufacturer to classify devices under the classification system, which assesses the degree of risk. The classification is what determines whether a device falls within this restriction.

The rule protects users from using dangerous devices without medical supervision. Pharmacies and distributors who dispense devices to the public must check the list. Anyone with a question about a particular case can consult a lawyer who specializes in health and commercial regulations.