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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
You can check if the medical product has already obtained marketing permission via:
https://sfda.gov.sa/ar/medical-equipment-list
or
You can send an inquiry about the product to the following email: md.rs@sfda.gov.sa
including (manufacturer name, brand name, model).
Manufacturers, Authorized Representative, Importers, Distributors shall report to the SFDA, upon
becoming aware that adverse event, incident, a complaint has occurred, as follows:
− Not later than (2) working days from the date of awareness, if the adverse event, incident,
and complaint represent a serious public health threat.
− Not later than (10) working days from the date of awareness if the adverse event, incident,
complaint that results in an unanticipated death or unanticipated serious injury.
− Not later than (30) calendar days from the date of awareness for all adverse events, incidents,
complaints which are not associated with high risks.
− If SFDA initiate a report of adverse event, incident, complaint, the response shall be received
within (5) working days.
You must adhere to the announcment for responsible person for medical devices post market surveillance: https://www.sfda.gov.sa/ar/medicaldevices/circulations/DocLib/MD-ddd.pdf
* Notification from the authorised representative to the distributor of the details of the problem and the required procedures and bearing full responsibility
* Follow-up in applying the corrective action
* Inform the SFDA of the updates with evidence of communication and follow-up
Food poisoning is illness caused by any harmful amount of a natural or contaminating substance in a food, but especially illness caused by some highly infective kinds of bacteria. If not prevented -- as it can be by care and good hygiene -- some kinds of bacteria can grow to large numbers in food and produce toxins (poisons) some of which are difficult to destroy by cooking. Other kinds can cause illness by growing to large numbers in the digestive system. Symptoms include abdominal pain, diarrhoea and vomiting, and may last from a few hours to a few days. In extreme cases food poisoning can prove fatal, especially to babies, the elderly and others with weakened immune systems.
A notification issued by the National Center for Medical Devices Reporting stating the risk associated with the medical device or product and the corrective actions to be taken; To avoid the risk associated with it.
You can choose either wood or a nonporous surface cutting board. Research shows that nonporous surfaces, such as plastic, marble, tempered glass, and pyroceramic are easier to clean than wood. Wood surfaces are considered porous. Once cutting boards become excessively worn or develop hard-to-clean grooves, you should replace them. Even plastic boards wear out over time.
In the event that the hospital refuses to enter the employee of the authorised representative to sign or deliver the document, the authorised representative must send an official letter explaining the case and the Field Safety Notice, through registered mail to the person in charge by the hospital but if the responsible person is not present at the hospital or refused to sign or receive the required document, the authorised representative employee must raise this case to the higher management inside the hospital.