Article 8 of the Saudi Medical Devices Law

While Article 6 requires a license for the establishment, this article requires a separate authorization for each medical device or supply. None may be circulated except after:

• Registration in the national register kept by the Authority.
• Obtaining the marketing authorization, which under Article 1 is a document the Authority issues allowing the device to be circulated in the markets.

Circulation under the Law includes making a device available free of charge or for a fee, for distribution or for use, so free distribution also needs the authorization.

The exception: the Authority may exempt some devices and supplies from the marketing authorization requirement, but on two conditions:

1. That it confirms their safety.
2. That they are not used for commercial purposes.

The exemption is under rules approved by the Authority's board of directors, so an exemption should not be assumed without a decision. Note that the exemption concerns the marketing authorization, and the text does not mention registration within it.

Article 9 provides a special rule for innovative devices, and Article 10 refers the conditions for registration and issuing the marketing authorization to the Regulations. To ask about the status of a particular product, you can consult a lawyer who specializes in health and commercial regulations.