How to update the responsible person information in the radiation emitting medical devices assessment report?
Answer
Contact the radiological health executive administration via this e-mail: rh.md@sfda.gov.sa
Question
What are the requirements of evaluating the safe use of radiation emitting medical devices in healthcare facilities?
Answer
"You can find the requirements and guidance through this link
https://www.sfda.gov.sa/sites/default/files/2021-03/RequirementRadiationProtectionSafetyE.pdf
Question
"What are the importation and clearance requirements for medical imaging products? "
Answer
The importation and clearance requirement is being updated and it will be published soon.
Question
What are Medical Imaging products?
Answer
They are non-radioactive pharmaceutical products or products used in radioscopy, and SFDA approval is required for importing
Question
Is there a fixed Percentage of Saudization of jobs for whom request to be a service provider for Quality Assurance and Radiation Measurements?
Answer
thers is no fixed percentage, however, each company shall have A Saudi RSO, specialists, and experts as well
Question
What is the Validity of Quality Assurance and radiation measurements service provider license?
Answer
The liscince is valid for 3 years starting from issue date
Question
What is the process to submit a request for being service provider of Quality Assurance and Radiation measurements?
Answer
by submit the request through SFDA administration communcation system to Establishment License Department in Operation Sector
Question
When submitting an import or re-export request through the company, the name of the medical facility, radioactive material or manufacturer does not appear in the list?
Answer
In order the name of the beneficiary appears, the medical facility must register in the electronic system, and complete all requirements and take the final approval of the application, and It is possible to add radioactive material or manufacturer by sending an E mail to Radiological Health Exicutive Dept. : rh.md@sfda.gov.sa
Question
Can the amount of radioactive materials entered into the electronic system be exceeded?
Answer
The quantity cannot be exceeded until it is modified in the practice license, then modify the data in the electronic system.
Question
What are the medical radioactive materials that can be ordered through the electronic system?
Answer
Only, the radioactive materials that are licensed to a health facility in a practice license.
