Objective: bjective:

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:
    1. National and international recalls ) field safety corrective action)
    2. 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 .