Final Guidance on Saudi Arabia’s Medical Device National Registry (MDNR) Route Published
Regulatory Updates | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- The Saudi Food and Drug Authority (SFDA) has issued final guidance on its Medical Device National Registry (MDNR) market pathway for low-risk devices.
- The final guidance includes additions and clarifications to MDNR flowchart and declaration of conformity requirements.
- MDNR listing requirements for Class I non-sterile, non-measuring devices will go into effect in September 2018.
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.
MDNR flowchart additions
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:
- Random Review Process: Although SFDA has yet to provide any additional details regarding what type of data would be reviewed, this process may target Essential Principles of Safety in Performance described in Annex 3.
- Continuation of Medical Device Listing: SFDA has no renewal process in place for MDNR listings, so once a three-year MDNR listing expires, a manufacturer must reapply for listing through its Saudi distributor.
- Recall and Withdrawal: SFDA has not yet established a formal recall process for devices with MDNR listings, but any eventual recall process may be similar to the MDS-G22 Guidance on Requirements for Following Up and Closing Medical Devices Field Safety Notices.
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.