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)