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.