Our Services

With 20 + years of experience and extensive knowledge of KSA Medical Devices market and regulations. MRG has registered 100,000+ medical devices with the SFDA, covering medical devices of all classifications and various jurisdictions.

MRG’s Consultation Services and Regulatory Services

For KSA:

We provide high quality regulatory services corresponding with SFDA on behalf of manufactures:

• Submitting and obtaining Medical Device Establishment License (MDEL) with the Saudi FDA.
• Submitting and obtaining Medical Device Marketing Authorization (MDMA) with the Saudi FDA.
• Inform the Saudi FDA of any changes in the product or any information about the manufacture.
• Assisting in adverse event reporting to the Saudi FDA.
• Assisting in device field corrective action plans (Recalls)
• Submitting Medical Device Classification with the Saudi FDA.
• Assisting local companies to register with Medical Device National Registration (MDNR) with the Saudi FDA.
• Assisting manufactures with consultation about SFDA, MOH.

For UAE:

• Submitting Product registration with the ministry of health (MOH)
• Listing of product with the health authority – Abu Dhabi (HAAD)
• Listing products with Dubai Health Authority (DHA)
• Registering all medical products, as well as fulfilling all the post-marketing requirements of Emirates standardization & Metrology for Authority (ESMA)