The Saudi FDA's NCMDR gathers and assesses data on medical device safety and performance, allowing stakeholders to report incidents for improved safety and compliance in Saudi Arabia by contacting the Authorized Representative (AR) on behalf of the manufacturer.
This data-driven system enhances safety standards, identifies issues, and facilitates necessary regulatory actions.
Enhanced Patient Safety: By collecting and analyzing reports of Failure Safety Notice (FSN), adverse events, and malfunctions, the NCMDR helps identify risks associated with medical devices.
Improved Device Quality: The feedback from the NCMDR allows manufacturers to identify and resolve issues with their devices.
Regulatory Actions: The Saudi FDA uses data from the NCMDR to take timely and appropriate regulatory actions, such as issuing recalls, safety alerts, or additional testing which can be only performed by the manufacturers.
Continuous Improvement: The NCMDR facilitates continuous monitoring and improvement of medical devices throughout their lifecycle as long as they have access to the Saudi market.
The Saudi FDA's NCMDR gathers and assesses data on medical device safety and performance, allowing stakeholders to report incidents for improved safety and compliance in Saudi Arabia by contacting the Authorized Representative (AR) on behalf of the manufacturer.
This data-driven system enhances safety standards, identifies issues, and facilitates necessary regulatory actions.
Enhanced Patient Safety: By collecting and analyzing reports of Failure Safety Notice (FSN), adverse events, and malfunctions, the NCMDR helps identify risks associated with medical devices.
Improved Device Quality: The feedback from the NCMDR allows manufacturers to identify and resolve issues with their devices.
Regulatory Actions: The Saudi FDA uses data from the NCMDR to take timely and appropriate regulatory actions, such as issuing recalls, safety alerts, or additional testing which can be only performed by the manufacturers.
Continuous Improvement: The NCMDR facilitates continuous monitoring and improvement of medical devices throughout their lifecycle as long as they have access to the Saudi market.
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