The Food and Drug Authority received 16,855 reports regarding medical devices and products during the first quarter of 2021, with a daily rate of more than 187 reports, the highest of which was last February with 8,932 reports, followed by March with 4,334 reports, then January with 3,589 reports.
What is the definition of the medical device / product?
Every machine, tool, medical application device, implant device, reagents, laboratory standards, programs, operating materials for medical devices, or any similar or related tool is manufactured to be used alone or with other human devices for one or more of the following purposes:
* Diagnose, prevent, monitor, treat, mitigate or relieve diseases.
* Diagnose, monitor, treat, mitigate or relieve injuries, or compensate for those injuries such as sterilization materials.
* Examination, replacement, modification, or anatomical support for the functions of the body’s organs, such as eyeglasses, and assistance for the disabled and people with special needs.
* Supporting or enabling life to continue.
* Pregnancy regulation.
Sterilization of medical devices.
* Giving information for a medical or diagnostic purpose through laboratory tests of samples taken from the human body.
* Devices that cannot achieve the actual purpose for which they were made in or on the human body by means of a drug, immune factor, or metabolic transformations, but rather help to achieve their effects only.
When should medical device accidents that take place inside the Kingdom be reported?
The local or foreign manufacturer, through its legal representative, must immediately inform the authority of any accidents or problems that a corrective measure has been decided upon that are found in the Kingdom’s markets. He must also inform the Authority of any calls or safety warnings as soon as he becomes aware of them.
What problems with medical devices and products should I report?
To report a problem, all the following conditions must be met:
1- The occurrence of the problem.
2- That the problem led or may lead (if it recurs) to one of the following consequences:
A- The death of the patient, user, or any other person.
B- Serious injury to the patient, user, or any other person.
3- The accident is related to the factory’s medical device / product.
Examples of accidents:
Errors in the usage instructions and / or identification card
Malfunctions and damages
– The medical device / product does not perform the purpose for which it was designed
Interference with other medical devices or products
Errors caused by wrong use
Combination of the above problems
* Distribution of medical device reports during the first quarter of 2021:
1,446 reports from health care providers
2870 reports from medical device companies
18 reports from individuals
7,643 reports from healthcare providers
1276 reports from medical device companies
13 reports from individuals
1,761 reports from health care providers
1824 reports from medical device companies
4 reports from individuals