Medical Device Marketing Authorization (MDMA)

What is MDMA?

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

MDMA is a must-have for selling medical devices and In-Vitro Diagnostics (IVDs) in Saudi Arabia.

Process:

Step 1 - Document Review: We meticulously assess your documents for compliance.

Step 2 -Translation Assistance: We advise on necessary translations (English is preferred, Arabic only for specific cases).

Step 3 - Saudi FDA Submission: We handle the online application submission process.

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

‍Benefits of MDMA Approval:

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

Credibility: Demonstrate product quality and regulatory compliance.

Growth Potential: Take advantage of a profitable and growing healthcare market.

‍Why Choose REG SOLUTIONS?

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.

Compliance Guarantee: We ensure your documents meet all Saudi FDA regulations, saving you time and hassle.