We are an independent Authorized Representative and Medical Devices Regulatory Service provider in Saudi Arabia, Intelligent Regulations is a KSA licensed Authorized Representative and is operated by a highly experienced team specializing in SFDA regulations & Systems.
We are human counselling and assist you with to complete your requirement in SFDA
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. 8976. 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.
The Numbers Don’t Lie
Per SFDA process, All medical devices & IVDs intended to be marketed in the Saudi Arabia should have a valid Medical Device Marketing Authorization (MDMA) as per the enforcement dates.
Our services are based on medical devices regulation in Saudi Arabia in order to ensure your compliance with SFDA.
Designed By Mohmmad Alahmad 2020. All rights reserved.