1. Enter to the link : https://ade.sfda.gov.sa/Home/NcmdrReport
2. choose the Type of user,  as needed login
3. Access the Reporting Service
4. Fill out the form.
5. 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.

1. Access the MRMR system through the link (mrmr.sfda.gov.sa)
2. Create an account in the system according to the type (medical establishment, Importer/exporter establishment or carrier establishment)
3. Submit an application for approval of technical and clinical specifications for the purpose of importing or re-exporting medical radioactive materials
4. Submit the required documents
5. If the requirements are met, a certificate of approval of technical and clinical specifications of medical radioactive materials will be issued.

1- Valid Medica Devices Establishment License (MDEL) for importers and exporters of radioactive material. 2- Neccessary licenses to practice activities related to medical radioactive materials for the medical establishment and carrier establishment 3- Submit all the documents required to study the application

• What are the facilities targeted in the service ?    

        - Importers and exporters establishments
        - Carriers establishments
        - Medical establishmets
        - Medical Radioactive Material producers establishments

• Is it required to pay a fee to open an account in the  system?

      -  No fees are required to open an account in the  system at the present time

• Is there an expiration date for approval certificate ?

      -  Yes, the approval is valid for three months from the issuance date.

• What are the medical radioactive materials that can be requested through the system?

      -  They are the medical radioactive materials licensed to the medical establishments in the practice license only, and in the same quantity and licensed activity.

• When submitting an import or re-export application through the user, the name of the medical establishment does not appear in the list of beneficiary facilities?

      -  In order to show the name of the beneficiary facility, the medical establishemt shall register in the system, complete all requirements and obtain final approval of the application.