FAQs

• Do not move the medical device or its accessories unless it poses a danger to the patient or medical staff. • Do not change the control settings for any medical device. • Do not disconnect or dispose of any disposable or disposable accessories or parts such as wires, catheters, electrodes, tubes belonging to the medical device ... etc., as their presence is important in understanding the event. • Adequate capture of photos. • Document: who was there, who worked, what happened, etc.

Do not differ, rather, it is the legal representative / The factory informs the authority in case of accidents and deaths in accordance with the announced reporting standards 

Home use medical devices reports

Means an action taken by a manufacturer to reduce or remove a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market. The following are examples of these types of procedures: • Checking the device to ensure that it is free from problems

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