Our Services

For KSA 

Medical Devices Registration:

  • Submitting Medical Device Establishment License (MDEL) with the Saudi FDA.
  • Submitting 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.

 

Cosmetic Registration:

  • Applying for new manufacturer initial approval
  • Applying for new manufacturer license request
  • Submitting Update of manufacturer license request
  • Submitting Update of manufacturer location/Physical Address
  • Submitting Update of manufacturer ownership
  • Submitting Cosmetic Classifications
  • Obtaining Cosmetic License from SFDA

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)