Authorized Representative
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Authorized Representative
According to Saudi Food & Drug regulations, Medical Device manufacturers who are not based in the kingdom of Saudi Arabia (KSA) must appoint a local Authorized Representative. The Authorized Representative act as a liaison between you and the kingdom of Saudi Arabia Food & Drug Authority(SFDA), as specified by the Medical Devices Interim Regulation(MDIR), Decree No. 1-8-1429/2008. The Authorized Representative assumes regulatory representation for the products in the KSA Market and is responsible for submitting registration of your Device with the SFDA.
Medical Device Registration and regulations in Saudi Arabia is based on companies already having approval in one of the following reference markets: Australia, Canada, Europe, Japan, and/or the USA, and registration in one of these markets is mandatory in order to register in Saudi Arabia. Submit the Authorized Representation registrations with the Saudi FDA.
- Submit the obtaining Authorized Representation registrations with the Saudi FDA
- 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, in close liaison with you and distributors
- Assisting in device field corrective action plans (Recalls)
- Submitting and obtaining Product classification from SFDA
- Assisting local companies to register with Medical Device National Registration (MDNR) with the Saudi FDA
- : Assisting distributors to obtain import permit licenses (MDIL) prior to shipments