Report Medical Device Adverse Events

Report Medical Device Adverse Events

The objective of this Medical Device Adverse Event Reporting System is to improve the protection of health and safety of patients, users and others through information dissemination that may reduce the likelihood of, or prevent, repetition of adverse events, or alleviate consequences of such repetition.

This System is designed for the Local Responsible Persons to submit the reportable adverse events related to their listed products, and which are suspected to have caused death or serious injury, or which may lead to death or serious injury if it recurs. The act of reporting an event is not to be construed as an admission of manufacturer, user, or patient liability for the event and its consequences. Submission of an adverse event report does not, in itself, represent a conclusion by the manufacturer that the content of this report is complete or confirmed, that the devices listed failed in any manner. It is also not a conclusion that the device caused or contributed to the adverse event.

The Local Responsible Person is responsible to conduct investigations into the events of their listed devices and submit the report to the Medical Device Division as required under the Medical Device Administrative Control System. The event could be reported by filling in the reporting form and send back to us.

Reporting form

Medical Device Adverse Event Report Form – for Medical Device Users
Medical Device Adverse Event Report Form – for Local Responsible Persons

Please submit the report through the following channels:

  1. By Mail: Medical Device Division, Room 604, 6/F, 14 Taikoo Wan Road, Taikoo Shing, Hong Kong.
  2. By Fax: (852) 3157 1286;
  3. By email: