We facilitate global registration in Saudi Arabia, ensuring regulatory compliance and efficient legal representation for your entry into the Saudi market.
You must also appoint an authorized representative in Saudi Arabia if you do not have an office or entity in Saudi Arabia.
Your Authorized Representative (AR) must obtain an Authorized Representative License, which is renewable annually, to legally represent you in KSA.
Your KSA authorized representative is also responsible for submitting all application documents to the SFDA to register your device. The SFDA assigns an official review period of 35 business days for applications; however, actual review times are often longer, especially if additional information is requested.
The recently established Saudi route by the SFDA requires a Technical File Assessment (TFA) for market authorization, and the SFDA has implemented its own classification system for medical devices.
Prior approval in the country of origin is not a prerequisite for registration in KSA, and reference country approval is not required for MDMA registration; however, any proof of existing approvals in other markets is requested as part of the registration documentation.
CMC can assist you in entering the Arab market by registering your products with the SFDA.
