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Safety Information

Revised: 29 August 2013

Overview of how Medsafe manages medical device adverse event reports

Medsafe receives adverse event reports of medical devices from users, healthcare professionals and the medical device industry.

The reports can be received via faxes, letters and e-mails. These reports are entered into Medsafe's regulatory database by Medsafe staff. All reports are checked by us for correctness and completeness.  Valid reports received after 1 January 2013 may be published in the publicly accessible database, Joint Adverse Event Notification System – Medical Devices.

How to report a problem

Risk Assessment

All reports are entered into a database assessed for risk and kept for future reference.

Investigation

The investigator will:

Final outcomes may include:

Medsafe also exchanges information on significant incident investigations with overseas regulatory authorities.

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