SFDA Regulatory Affairs
Our expert regulatory support in medical devices. Establishment License (MDEL):
Importers and Distributors, Manufacturers, or Authorized Representatives (AR).
We can be your Authorized Representative.
Medical Device Registration
1
Medical Device National Registration Number (MDNR).
2
Medical Device Establishment License (MDEL).
3
Medical Device Importation License (MDIL).
4
Medical Device Marketing Authorization (MDMA).
Compliance with the Saudi FDA’s General Provisions and Enforcement Surveillance and Biometrics.
1
Submission of a Medical Device Establishment License (MDEL) with the Saudi FDA.
2
Submission of a Medical Device Marketing Authorization (MDMA) with the Saudi FDA.
3
Informing the Saudi FDA of any changes in the product or any information about the manufacturer.
4
Assisting in adverse event reporting to the Saudi FDA.
5
Assisting in device field corrective action plans (Recalls).
6
Submission of a Medical Device Classification with the Saudi FDA.
7
Assisting local companies to register with Medical Device National Registration (MDNR) with the Saudi FDA.
Cosmetic Registration
1
Application for a new manufacturer’s initial approval.
2
Application for a new manufacturer’s license request.
3
Submission of an update of the manufacturer’s license request.
4
Submission of an update of the manufacturer’s location/physical address.
5
Submission of an update of manufacturer ownership.
6
Submission of a Cosmetic Classifications.
7
Obtaining a Cosmetic License from the SFDA.