Jul 23, 2018
EMERGO SUMMARY OF KEY POINTS:
The Saudi Food and Drug Authority (SFDA) has issued final guidance on its new Medical Device National Register or MDNR market authorization route for low-risk devices.
According to an analysis by Emergo sources and consultants in Riyadh, the SFDA final guidance does not deviate substantially from previous iterations of the MDNR market pathway. Additional information has been added to the guidance’s flowchart as well as declaration of conformity requirements, however.
SFDA’s additions and clarifications to the final guidance flowchart pertain to Random Review Process, Continuation of Medical Device listing, and Recall and Withdrawal sections:
In addition, the final SFDA guidance identifies required data for inclusion in declarations of conformity; such information should include device model names and/or numbers as well as classification rule numbers.
SFDA has pushed back implementation deadlines for the MDNR market pathway to September 2018. Following that deadline, Class I non-sterile, non-measuring devices will have to meet SFDA MDNR requirements to enter the Saudi market.
EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS