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Question

How can I communicate with those in charge of MRMR system?


Answer

For inquiries, contact the radiological health executive administration via this e-mail: rh.md@sfda.gov.sa


Question

How can I apply for an application to import, re-export or transfer a medical radioactive material?


Answer

Healthcare provider, transporter and importer/exporter facilities should all register and take final approval to submit import, re-export or transfer of medical radioactive material request. 


Question

How can I update the beneficiary information after completing the registration and approval processes?


Answer

1. Login with user name and password. 2. Choose update. 3. Confirm update.


Question

How can I register in the MRMR system?


Answer

1. Register an account through the link: https://mrmr.sfda.gov.sa 2. Fill-in personal data and choose the type of facility. 3. Activate your account via the link sent to the registered email, 4. Login with user name and password. 5. Send a request, after you fill out all required fields attaching all required documents.


Question

Are there fees to register in MRMR system?


Answer

Currently, no fees are required for registering in the system. 


Question

Who are the involved facilities in MRMR system?


Answer

1. Import/export of medical radioactive materials facility. 2. Transport of medical radioactive materials facility. 3. Healthcare providers that use radioactive materials. 4. Production of medical radioactive materials facility.


Question

What is the medical radioactive material registration (MRMR) system?


Answer

An electronic system launched to facilitate the importing, transporting and exporting of medical radioactive materials registering requests. Furthermore, it contributes to the coordination between all relevant parties to ensure the arrival of those materials to the beneficiary in accordance with the authorized activity and quantity, you can login to the system through: https://mrmr.sfda.gov.sa


Question

What is a radioactive material?


Answer

Any material from which ionizing radiation is emitted, whether alone or within other equipment, classified as subject to the control of the SFDA. Including, naturally occurring radioactive materials.


Question

What are the expected outcomes of post-marketing evaluation studies?


Answer

• Corrective actions • Preventative measurements • Request additional clinical studies to provide the evidence of the safety and efficiency of the medical device • Disseminating safety communication to users and health care providers


Question

What do we mean by post-marketing evaluation studies?


Answer

These are studies that are conducted with a scientificmethodology on a medical device to verify its safety / effectiveness as a result of the presence of safety signals on that device that is marketed locally


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