Medical Devices Problem Reporting Center (MDPRC)

MDPRC is devoted to receive the technical problem reports and feedback information about any medical devices malfunction from hospitals and healthcare facilities all around KSA, studying them and working together with manufacturers and suppliers to take the right action and assuring the proper safe performance.

The center also aims to cooperate with the other international problem reporting centers to exchange reports received about medical devices used anywhere. Medical Devices Sector has membership of AHWP which work closely with Global Harmonization Task Force (GHTF).

Goals of MDPRC

Establishment of MDPRC was in order to achieve following goals:

· To keep safety on track with the emerging medical devices market

· To maintain a sharing information policy with other organization according to Global Harmonization Task Force (GHTF) mission

· To reduce likeliness of occurrence of adverse incidents

· To prevent likeliness of occurrence of previous adverse incidents.

· Increasing the overall healthcare proficiency for patients

· To protect users and patients from undesired results of faulty devices.

· To maintain a blame-free relation with manufacturers, suppliers and hospitals in order to increase communication efficiency and certainty of accidents.

Importance of MDPRC

As part of its public mandate to protect patients and health professionals, the Saudi Food and Drug Authority (SFDA) maintains an online medical devices problem reporting system. The purpose of the system is to identify events in which:

· A patient, staff member, or visitor may have suffered harm as a result of failure or misuse of a medical device

· Medical devices fail and harm the environment

· Significant medical devices failures occur and are likely to recur and harm people or the surroundings.

For more information please visit our site

http://mdprc.sfda.gov.sa/