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)