Saudi Regulators Adjust Timeframes for Medical Device Market Application (MDMA) Submissions

EMERGO SUMMARY OF KEY POINTS:

• The Saudi Food and Drug Authority (SFDA) has announced updates to certain timeframes for Medical Device Market Application (MDMA) submissions.
• Revised MDMA deadlines pertain to registration payments and responses to SFDA requests for additional information.

Medical device regulators at the Saudi Food and Drug Authority (SFDA) have updated deadlines for pending Medical Device Market Application (MDMA) submissions.

According to Emergo by UL sources in Riyadh, new MDMA timeframes for manufacturers and their in-country representatives in Saudi Arabia set by SFDA entail the following:

• Saudi Arabia Authorized Representatives of overseas Saudi market applicants must submit payment for MDMAs within 30 days of receiving payment requests from SFDA. Missed payment deadlines will result in deleted applications.
• Applicants have 60 calendar days to respond to additional information requests from SFDA. Refunds will not be given for deleted applications if this deadline is missed.
• Returning MDMAs to SDFDA with incomplete responses to requests for additional information will also result in deleted applications.
• Applicants may formally ask for additional time beyond the 60-day timeframe to respond to SFDA information requests by emailing the regulator.

Emergo consultants will provide updated details regarding these changes as they become available from SFDA.

Related Saudi Arabia medical device market resources from Emergo by UL:

• Saudi FDA medical device registration and approval consulting
• Saudi Arabia Authorized Representative in-country representation
• Video overview: Saudi Arabia’s medical device approval process
• Regulatory process chart: Saudi Arabian registration for medical devices