Medical Device Advertising License (MDAL) in Saudi Arabia

SFDA Approval for Medical Device and IVD Advertising and Promotion

Ensure Your Medical Device Advertising Materials Comply with SFDA Requirements

Advertising and marketing activities for medical devices and In-Vitro Diagnostic Devices (IVDs) in Saudi Arabia are strictly regulated by the Saudi Food & Drug Authority (SFDA). Any promotional content  including digital marketing, social media campaigns, educational events, product awareness materials, or healthcare professional promotions  requires prior SFDA approval before publication or distribution.

At Bio-Standards, we help manufacturers obtain Medical Device Advertising License (MDAL) approvals efficiently and compliantly  ensuring your marketing activities align with SFDA regulatory requirements and Saudi market standards.

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Scope

The requirement to obtain a Medical Device Advertising License (MDAL) applies to:

• Advertising and promotion of medical devices and supplies directed to the public in Saudi Arabia.

• Organizers of awareness or charitable campaigns involving medical devices.

• Medical devices displayed at exhibitions for demonstration or promotional purposes.

• Workshops and presentations that include claims related to medical devices.

• Advertising medical devices through influencers or social media content creators.

This requirement does not apply to imported samples intended solely for display purposes, which are governed under separate SFDA importation permit requirements.

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How Bio-Standards Supports Your MDAL Approval

Our team supports you through the full MDAL approval process, including:

• Reviewing advertising materials for SFDA compliance.

• Aligning promotional claims with approved Medical Device Marketing Authorization (MDMA) documentation.

• Managing the SFDA submission process.

• Assisting with social media and influencer campaign compliance.

• Supporting awareness and educational campaign approvals.

• Coordinating directly with the SFDA during the review process.

• Advising on Arabic and English content compliance requirements.

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Why Medical Device Manufacturers Choose Bio-Standards as Their Regulatory Compliance Partner

• Deep expertise in SFDA medical device regulations.

• Strong command of Saudi advertising compliance requirements.

• Proven experience supporting international and local manufacturers.

• Integrated support across the full medical device lifecycle.

• Faster, smoother communication with the SFDA.

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Promote Your Products Confidently in Saudi Arabia

Obtaining MDMA approval is only the first step. Ensuring your marketing and promotional activities comply with SFDA requirements is essential for successful market expansion in Saudi Arabia.

Partner with Bio-Standards to manage your MDAL approval process compliantly and efficiently.

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