To protect the public against the circulation of medical devices that do not meet the requirements of safety, quality and benefits, it is necessary to supervise the safety of medical devices in the form of Supervision of Adverse Events (AEs) of Medical Devices which must be carried out by business actors / owners of distribution licenses. Meanwhile, users in health care facilities can report voluntarily if there is an Adverse Event (AEs) in the use of a Medical Device.

The AEs Reporting Procedure is intended as a guide for business actors / distribution permit holders and users in health care facilities in reporting Adverse Events (AEs) of medical devices.