Navigating Medical Device Advertising in Saudi Arabia: A Guide to Regulatory Compliance

In Saudi Arabia, advertising medical devices is a carefully regulated activity, guided by specific rules to ensure compliance with both Sharia law and public decency standards. For companies looking to navigate this complex landscape, understanding the Saudi Food & Drug Authority's (SFDA) latest guidelines is crucial.

Regulatory Background

The SFDA's control over medical device advertising is stringent, with specific requirements and restrictions designed to prevent misleading information from reaching both healthcare professionals (HCPs) and the general public. The updated guidance, known as MDS-REQ 8, outlines the necessary steps for obtaining advertisement approval for medical devices, ensuring that all promotional activities adhere to regulatory standards.

Key Requirements for Advertising

1. Approval Process: All promotional materials related to medical devices must first receive approval from the SFDA. This includes advertisements aimed at both the general public and HCPs, and applies to digital platforms as well.
2. Mandatory Information: Advertisements must include the medical device's name, the manufacturer’s trademark, and the MDMA certificate or advertisement approval number. The language of the advertisement must be Arabic for the general public, while advertisements intended for HCPs should be in English.
3. Content Restrictions: Advertisements must not contradict Islamic Sharia law, societal norms, or the manufacturer's claims about the device. Misleading comparisons or unapproved claims are strictly prohibited.
4. Digital and Social Media Specifics: For digital advertisements, including those on social media, a prior notification to the SFDA is required 12 hours before publication. Information about the advertiser, social media account, and date of publication must be included in the notification.

Enforcement and Penalties

The SFDA actively monitors compliance with advertising regulations. Non-compliance can lead to severe penalties, including suspension or termination of licenses, product recalls, or withdrawal of marketing authorization. The enforcement mechanism ensures that advertisements do not mislead the user about a medical device's performance and that they adhere strictly to approved data.