EMERGO SUMMARY OF KEY POINTS:

• The Saudi Food and Drug Authority plans to require more clinical data for some Medical Device Marketing Authorization (MDMA) applications.
• Details and timeframes for the new requirements are forthcoming from the SFDA.
• Additional clinical data the SFDA may require of applicants includes clinical evaluation reports (CER), post-market surveillance plans and post-market clinical follow-up (PMCF) reports.

Saudi Arabia’s medical device regulator, the Saudi Food and Drug Authority (SFDA), plans to introduce changes to the application process for obtaining market authorization in the country.

According to Emergo sources in Riyadh, some device manufacturers and their Saudi Arabia Authorized Representatives were recently informed of the SFDA’s pending changes to its Medical Device Marketing Authorization (MDMA) process, and that enforcement timeframes as well as additional details for the new requirements are forthcoming from the regulator.

Additional clinical data requirements for some MDMA submissions

In general, the SFDA will require additional documentation for certain devices whose MDMA submissions lack adequate clinical data regarding safety and efficacy. The SFDA may require clinical evaluation reports (CER), post-market surveillance (PMS) plans and reports, and post-market clinical follow-up (PMCF) plans and reports, our Riyadh office has been informed.

In cases where SFDA reviewers require additional clinical data, MDMA approval may take longer, according to the regulator.

We will report further on additional details and timeframes regarding MDMA changes as we learn them.

Learn more about Saudi Arabia MDMA resources and support:

• SFDA registration consulting for medical device companies
• Saudi Arabia Authorized Representative service for foreign manufacturers
• Whitepaper: SFDA medical device registration
• Video overview of Saudi Arabia’s registration process