means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat
Question
Incident
Answer
means any malfunction or deterioration in the characteristics or
performance of a device made available on the market, including use-error
due to ergonomic features, as well as any inadequacy in the information
supplied by the manufacturer and any undesirable side-effect
Question
Who can report?
Answer
Everyone can report: users, health practitioners, manufacturers, authorized representatives, suppliers or distributors.
Question
"How to report medical devices adverse events, incidents and complaints?"
Answer
Through one of the following channels:
• National Centre for Medical Device Reporting (NCMDR) website
https://ncmdr.sfda.gov.sa/default.aspx
• Saudi Vigilance
https://ade.sfda.gov.sa/
• Call center 19999
• Tameni App
Question
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
