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Saudi Arabia1. Authorities The Saudi Food & Drug Authority (SFDA) is responsible for regulating the sale and distribution of medical devices and in vitro diagnostic devices in Saudi Arabia. For most medical devices, a medical device marketing authorization (MDMA) approved by the SFDA is required before they can be put on the Saudi market.
2. Relevant Regulations Due to the reform on January 1, 2022, Saudi Arabia's registered country of origin approval is not a prerequisite. If your company needs to be listed, it needs to meet the certification requirements of one of the five GHTF countries (US, Japan, Australia, Canada, EU), but at this stage only CE Mark or FDA's Clearance Letter can basically meet the above requirements. Classification confirmation is carried out according to the Saudi Medical Device Classification Guide MDS-G008 as the standard, and the entire review requirements are very similar to the EU MDR.
3. Time estimation The average processing time for all risk levels is 4-6 months.
4. Local Representatives If an overseas manufacturer does not have a physical presence in Saudi Arabia, it must appoint a local authorized representative to serve as a bridge between the MF and the authorities. The main responsibilities of the Saudi local authorized representative are:
Submit AR application to SFDA authorities and assist in paying AR fees;
Submit MDMA registration application to SFDA authorities and assist in paying application fees;
Report any product changes to SFDA on behalf of MF;
Assist in reporting adverse events to SFDA and assist in taking equipment field safety corrective actions (recalls) in close contact with MF and distributors;
Serve as a bridge of communication between MF and SFDA at any time;
5. Successful Cases 3 0+Customer Success Cases |
