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Publications

Published: 7 September 2017

New Zealand is on Form for Medical Devices

Prescriber Update 38(3): 46
September 2017

Medsafe has now completed the redesign of the adverse event reporting forms for medical devices1. The new forms are specific for New Zealand users and allow for more information to be provided than the previous forms.

There are now separate adverse event reporting forms for:

In addition to these forms, there is a separate quality reporting form to identify an issue with a medical device that may not have caused an adverse event but has the potential to do so.

The new reporting forms are available from the Medsafe website (www.medsafe.govt.nz/regulatory/devicesnew/9AdverseEvent.asp).

Medsafe accepts reports from patients and their carers or relatives, healthcare professionals, and New Zealand suppliers/manufacturers of the medical devices.

Any adverse event or quality issue suspected of being associated with the use of a medical device should be reported to Medsafe. Adverse events and quality reports are reviewed by Medsafe to identify the cause of the issue and any consequential corrective actions. Following a review, Medsafe may publish a monitoring or alert communication (www.medsafe.govt.nz/safety/alerts.asp).

References
  1. Medsafe. 2016. Adverse Event Reporting for Medical Devices. Prescriber Update 37(4): 58. URL: www.medsafe.govt.nz/profs/PUArticles/December%202016/AdverseEventReportingMedicalDevices.htm (accessed 3 August 2017).
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