The Saudi FDA’s Post Market Surveillance is a centralized system that collects and
evaluates data on the safety and performance of medical devices in Saudi Arabia. It
allows stakeholders to report incidents by contacting the Authorized Representative
(AR) on behalf of the manufacturer.
Benefits of Saudi FDA Post Market Surveillance
Enhanced Patient Safety:
Identifies risks by collecting and analyzing Failure Safety Notices (FSNs),
adverse events, and device malfunctions.
Improved Device Quality:
Enables manufacturers to recognize and address quality or safety concerns in
their devices.
Regulatory Actions:
Facilitates timely Saudi FDA interventions like recalls, safety alerts, or
additional testing (performed only by the manufacturer).
Continuous Improvement:
Encourages ongoing safety improvements throughout the device lifecycle as
long as the product is available in the Saudi market.
Timeline: Response to Post Market Surveillance Based on Risk Level
Very High Risk:
Response within 2 working days
High Risk:
Response within 5 working days
Moderate Risk:
Response within 10 working days
Manufacturer Reporting Requirements
Serious public health threat:
Within 2 days of awareness
Unanticipated death or serious injury:
Within 10 days of awareness
Adverse events (non-high risk):
Within 30 days of awareness
SFDA-Initiated Reports:
Response required within 5 days of initiation
Service Details:
Validity
No fixed validity
Saudi FDA Fees
No fees apply for Post Market Surveillance processes.
