National Center for Medical Devices Reporting ( NCMDR ) A systematic database to manage medical devices' post-market activities, such as Medical devices reporting of Adverse events and complaints, as well as publishing the Safety alerts of Medical devices with follow-up implementation of the corrective actions to ensure the safety, efficacy and performance of medical devices.
- Enter to the link : https://ade.sfda.gov.sa/Home/NcmdrReport
- choose the Type of user, as needed login
- Access the Reporting Service
- Fill out the form.
- Submit / Sending the Report
To Enter as a Company you shall use Ghad Entry Details
- How to Report a complaint or adverse event?
- Go to the steps of the service and follow it.
- What should be reported?
- Report of any event that leads or might lead to undesired or unexpected issues regarding safety of patients, users, janitors or any other person. This may include the following:
- Problems with the design of the device.
- Untrained or unaware staff.
- Carelessness in use.
- Uninstructed modifications.
- Inadequate maintenance.
- Inappropriate conditions: storage, temperature and use.
- What actions will be taken by SFDA after receiving the reports?
- The SFDA will review and verify the reports, and take the necessary actions to ensure the safety of medical devcies.