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Report Adverse Incidents

 

Report Medical Device Adverse Incidents

The objective of this Medical Device Adverse Incident 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 incidents, or alleviate consequences of such repetition.

This System is designed for the Local Responsible Persons to submit the reportable adverse incidents 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 incident is not to be construed as an admission of manufacturer, user, or patient liability for the incident and its consequences. Submission of an adverse incident 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 incident.

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

Reporting form

For Medical Device users, please use the User Reporting Form PDF  doc

For Local Responsible Person and others, please use the LRP Reporting Form PDF  doc

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Please submit the report through the following channels:

1) By Mail: Medical Device Control Office, Room 604, 6/F, CityPlaza Three, 14 Taikoo Wan Road, Taikoo Shing, Hong Kong.
2) By Fax: (852) 3157 1286;
3) By email: mdco_air@dh.gov.hk

 
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Last Revision Date : 22 January 2013