SFDA MDMA Registration (Medical Device Marketing Authorization)

Medical Device Marketing Authorization (MDMA) is the official approval granted by the Saudi FDA (SFDA) that allows companies to market and sell medical devices and In-Vitro Diagnostics (IVDs) in Saudi Arabia. It confirms that your medical devices meet the required quality and safety standards before they enter the market.

Authorization attaches to the device rather than to the company, although devices may be bundled or grouped within a single application where they meet the SFDA grouping criteria. An application is submitted by the manufacturer, or by the Authorized Representative (AR).

If you are unsure how your product is classified, our Product Classification System (PCS) service can confirm the correct SFDA pathway first.

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The SFDA MDMA pathway

An MDMA application follows a defined sequence, and the depth of evidence required at each stage scales with the risk class of the device:

• Device classification. Devices are sorted into four risk classes, A to D, under the SFDA classification rules, with in vitro diagnostics classified under their own separate set of rules. Classification determines the documentation required. Our Product Classification System (PCS) service confirms the class before you apply.
• Technical documentation. Evidence that the device meets safety and performance requirements. For higher risk devices this includes product descriptions, risk assessments, clinical evaluations, and test reports. We assemble this as a complete technical file.
• Labeling. Labels must carry the particulars set out in the SFDA essential principles, including the details needed to identify the device and, where it is not obvious, its intended purpose. Instructions for use are supplied with the device, except that class A and class B devices can be exempt where they are safe to use without them. For devices intended for lay users, the information supplied by the manufacturer must be in both Arabic and English.
• Clinical and performance evaluation. The results of a clinical evaluation and the clinical evidence behind them are documented in a clinical evaluation report, which forms part of the technical documentation and supports the assessment of the device conformity. IVDs must demonstrate analytical and clinical performance through performance evaluation.
• Authorized Representative. A manufacturer based outside the Kingdom may apply directly or through an AR. Where an AR is appointed, it must already hold an SFDA licence covering that manufacturer, and it represents the manufacturer in its dealings with the SFDA.

After MDMA approval

Approval is the start of an ongoing obligation rather than the end of the process. Manufacturers must monitor how the device performs in use, report adverse events to the SFDA, and notify changes affecting the safety or performance profile. Our post-market surveillance and Saudi vigilance (NCMDR) reporting services cover these duties. Establishment and importation licensing through MDEL and MDIL then allows approved devices to be imported and distributed.

Our MDMA Application Process:

Step 1: Document Review: We carefully assess your technical documentation for Saudi FDA compliance.

Step 2: Translation Assistance: We advise on any required translations. Both Arabic and English are required for devices intended for lay users or for self-testing, and for implant card information. Manufacturer instructions for handling, storage, installation, maintenance and disposal must be available in English and, when requested, in Arabic.

Step 3: Saudi FDA Submission: We manage the entire online application submission process.

Step 4: Saudi FDA Communication: We represent you throughout the SFDA review process.

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Benefits of MDMA Approval:

• Market Access: Sell your medical devices legally and safely throughout Saudi Arabia.

• Credibility: Demonstrate product quality and full regulatory compliance.

• Growth Potential: Tap into one of the region’s fastest-growing healthcare markets.

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Why Choose Bio-Standards?

• Expertise: We understand the Saudi FDA’s requirements and bundling criteria for MDMA applications.

• Full Support: We handle everything, from document review and translation to submission and communication with the Saudi FDA.

• Submission-Ready Documentation: We prepare and review your technical documentation against current Saudi FDA requirements, so gaps are resolved before submission rather than during review.

MDMA approval is part of our end-to-end medical device registration services in Saudi Arabia. Download the MDMA e-book for the full process, or contact Bio-Standards for MDMA support.

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