Objectives:
Executive Management of Surveillance and Biometrics objectives are to monitor the medical devices after being placed onto the market to insure its compliance with SFDA- Medical Devices rules and regulations; and rapidly reacting to crisis via taking all necessary actions as well as Protecting whom ever in contact from unsafe medical devices.
Responsibilities:
Surveillance department:
- Receiving and collecting:
- National and international recalls ) field safety corrective action)
- Adverse Event reports from healthcare facilities, authorized representative, International and local Manufacturer, and Saudi public complaint.
- Follow up with establishments that have field safety notice of medical devices to assure taking appropriate action.
- Establish and develop a network - database involving different stakeholders (consumers, industry professionals, and governmental agencies and international organizations) to communicate with them any related medical devices concerns.
- Monitor the use of medical devices in KSA and take appropriate measures.
- Provide a database of information on the safety and performance of medical devices that is suitable for the exchange of adverse events information with other regulatory authorities .
Reporting and crisis management department:
- Conduct root cause investigation for valid Adverse Events .
- Technical support for medical device
- Conduct medical devices risk assessment and engage related studies .
- Disseminate relevant devices related information which may reduce the likelihood of, or prevent repetition of adverse event, or alleviate consequences of such repetition.
Auditory and Biometrics department:
- Review all medical devices documents that needs KSA-custom clearance in order to assure there are no field safety notice issued against them .
- Prepare and participate in medical devices research and study .
- Statistical data analysis for pro- action planning .
