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
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.
- 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)