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
Question
Is the approval of SFDA required to conduct a clinical study on a medical device ?
Answer
SFDA represented by the medical devices sector requires obtaining prior approval before conducting any clinical study in accordance with the requirements mentioned in the 'Guideline for the Requirements of Clinical Studies for Medical Devices and Products (MDS - G20) and in compliance with the International Standard (ISO 14155) Concerning Good Clinical Practice.
The guidelines of the requirements for conducting clinical studies on medical devices can be referred to through the following links on the SFDA website:
- النسخة العربية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20a.pdfG20)ar.pdf
- النسخة الإنجليزية: https://sfda.gov.sa/sites/default/files/2020-09/MDS-G20e_0.pdf
Question
If software update for a medical device imported to KSA is released, but this update is only for improvement not due to a problem or malfunction in the device. Is it mandatory to inform SFDA about this action and provide all the requirements for its closure?
Answer
In case there is a problem or malfunction affects patient or user’s safety, the manufacturer should issue the Field Safety Corrective Action and inform SFDA accordingly.
Question
In case the manufacture sells medical devices directly to customers without an Authorized Representative (AR), who is responsible for informing the affected customers and providing the corrective action plan and closure?
Answer
The manufacturer is responsible for the medical devices marketed in the KSA, as well as the supplier and distributor.
Question
If Field Safety Corrective Action is issued by the manufacture on specific serial or lot numbers, and these products with these numbers have not been imported into the KSA or put on the market, should we inform the SFDA about this Field Safety Corrective Action?
Answer
No, KSA is considered not affected in this case. But in case SFDA inquires about these products, you must provide a statement confirming KSA is Not Affected by Field Safety Corrective Action.
