Medical Device Advertising in Saudi Arabia: What Changed in MDS-REQ 8?

Version 4 turns advertising into a controlled regulatory record

On 20 July 2026, the Saudi Food and Drug Authority issued MDS-REQ 8 Version 4.0. Its final annex identifies changes from Version 3.0 dated 15 June 2022, so the main updates do not need to be inferred from wording alone. The operational message is clear: a medical-device advertisement should be controlled against the authorised device, approved claims, intended audience and exact published version. [1]

The first decision is whether the material falls within advertising. Version 4 defines advertising broadly as any written, audible, visual or other statement intended to promote and sell a medical device, supply or its technology, directly or indirectly. A website page, social post, creator script, video or product presentation may therefore fall within scope depending on its purpose and content. [1]

The documented changes in Version 4

The revised document explains two approval routes. Under the first, the manufacturer or authorised representative submits the advertising material within the technical documentation of the MDMA application. Under the second, an applicant seeks advertising approval through the electronic portal. The previous version described physical or email submission for the second route; the Version 4 change log expressly records the move to the electronic portal. [1] [2]

Version 4 also introduces an explicit requirement for social-media content creators. The creator must hold a Mawthooq licence for advertising-content creation, and the advertising material must still receive SFDA approval. An influencer contract or platform approval does not replace either requirement. [1]

The change log records added extension and renewal procedures and the requirement to pay the applicable fees for MDMA update requests. The current text distinguishes extending a valid approval from renewing an expired approval. For the second route, either may cover one or more years up to five years, subject to the applicable fees and evidence of the previous approval. First-route validity follows the MDMA certificate. [1]

For post-approval use, the change log notes an amendment to the item governing what appears on the material. The current rule requires the MDMA certificate number for first-route material, or the approval number and QR code for second-route material. Version 4 also changes the campaign rule on free samples and adds the MDMA certificate and the proposed awareness material to the documents required for an awareness or charitable campaign. [1]

The annex says that several general clauses were amended, added or removed, but it does not itemise every one of those edits. A precise clause-by-clause statement beyond the listed changes would require a documented comparison of both versions. This article limits its change claims to what the SFDA itself records. [1] [2]

What the current rule requires before publication

The Medical Devices Law and its Implementing Regulation establish the baseline: medical devices and supplies may not be advertised or promoted without SFDA approval. MDS-REQ 8 adds that the advertised device must hold a valid MDMA certificate. The material must not mislead users, conflict with the manufacturer’s claims, or include claims that the SFDA has not approved. It must not use the SFDA name or logo, disparage another device or make competitive comparisons with other companies’ products. [1] [3]

Audience selection affects the content. Arabic is required for material directed to laypersons, while English is required for healthcare professionals. Other languages may be used if they match the language of the material, and accessibility needs must be considered. Professional information must not be placed on websites intended for lay audiences. [1]

Creator-led social campaigns need additional control. The SFDA must receive the intended visual or audio material, or the proposed script, at least 12 hours before publication, together with the advertiser’s name, account and planned date and time. The contract must identify the content, display period, platform and contract duration. Replies to audience questions may not introduce information that was not previously approved. [1]

The highest risk is uncontrolled version drift

A campaign can begin with a supportable claim and become non-compliant during copywriting, translation or production. “Supports monitoring” becomes “prevents complications”; a time-to-result is added; the target user is shortened; or an Arabic adaptation broadens the intended purpose. Each change should be checked against the MDMA scope, the manufacturer’s approved claims and the underlying evidence. Approval of an initial layout is not permission to rewrite captions, scripts or responses later.

Channel changes need the same discipline. Version 4 requires a separate application for each advertising format when more than one format is used. It allows a change of display medium without a further approval only when the alternative medium was identified in the application, the approved content remains unchanged and the approval is still valid. A shortened video, new creator or revised claim may fall outside that allowance and should be assessed before use. [1]

A workable prepublication file

Start with one control record that identifies the device and models, MDMA certificate, audience, language, channel and format. Build a claim matrix that links every promotional statement to the intended purpose, supporting evidence and the version presented to the SFDA. Unsupported wording, or wording broader than the authorised scope, stays out until resolved.

Choose the approval route before fixing the launch date. Decide whether the material belongs in the MDMA technical documentation or needs a standalone portal application. Freeze the review package across copy, layout, audio, translation and the creator contract where relevant. Give each version a number and date, and record post-approval changes rather than silently replacing files.

Immediately before publication, verify the visible identifiers: device name, manufacturer name or trademark, and either the MDMA certificate number or the approval number and QR code, depending on the route. Confirm that the live asset is the approved version and that its validity, audience, channel and format still match the application. Retain evidence of the published version, date and channel, with a defined stop process if new safety or effectiveness information emerges. [1]

Where Basier fits

Basier reviews the consistency of the material and its claims against the product scope, regulatory documents and available evidence. A typical deliverable is a comment log and claim matrix showing the source for each statement, differences across copy, design and translation, and missing items that should be resolved before submission or publication. Version, channel and audience controls can be included in the same review record.

Basier does not issue advertising approval or guarantee acceptance or review time. The SFDA makes the decision, and the applicant remains responsible after approval. The best time to run this review is before filming and final production, when a claim or audience issue can still be corrected without rebuilding a finished campaign.

References: [1] [2] [3] [4]