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

 

MRG’s Consultation and Regulatory Services in KSA: 

 

  • Registering Manufactures site for Medical Device Establishment License (MDEL) with the Saudi FDA.
  • Registering Medical Device Marketing Authorization (MDMA) with the Saudi FDA on behalf of the manufacture.
  • Communicating with Saudi FDA of any changes in the product or any information about the manufacturer.
  • Assisting manufacturers with their post-marketing and vigilance reporting.
  • Classifying products with the Saudi FDA
  • Assisting local companies to register with Medical Device National Registration (MDNR) with the Saudi FDA

 

MRG’s Consultation and Regulatory Services in 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)

 

MRG’s Consultation and Regulatory Services in Lebanon: 

 

  • Providing Consultation Services for overseas manufacturers with regard to Medical Devices Regulations in Lebanon.
  • Assisting overseas manufacturer with registration of  Implantable Devices and Para-Pharmaceutical Products with MoPH (Ministry of Public Health).
  • Assisting local companies with registering their Medical devices with MoPH.
  • Working closely with local companies for Post-Marketing requirements.

 

MRG’s Consultation and Regulatory Services in Egypt: 

 

  • Providing Consultation Services for overseas manufacturers with regard to Medical Devices Regulations in Egypt.
  • Assisting overseas manufacturer with registration of Medical Devices with Ministry of Health (MoH) & Egyptian Drug Authority (EDA)
  • Assisting local companies with registering their Medical devices with MoH.

 

MRG’s Consultation and Regulatory Services in Pakistan: 

 

  • Submitting and obtaining Medical Device Establishment License with the Medical Device Board (MDB).
  • Submitting and obtaining Certificate of Enlistment or Registration of Medical Devices from MDB.
  • Working closely with MDB for Post Marketing Requirements.
  • Assisting local companies with registering their Medical devices with MDB.
  • Providing consultation services for overseas manufacturers, local manufacturers and importers with regard to Medical Devices regulations in Pakistan.