Published: 5 March 2020

Publications

The Medsafe Files – Episode 13: Medical device adverse event reporting

Prescriber Update 41(1): 17-18
March 2020

Key Messages

  • A key part of the post-market regulation of medical devices relies on adverse events and quality issues relating to devices being reported to Medsafe.
  • Anyone can report an issue associated with a medical device.
  • Medsafe uses adverse event reporting as a tool to investigate issues with medical devices. Medsafe investigations contribute to the safer use of medical devices in New Zealand.


Medsafe’s role in regulating medical devices focuses on post-market activities because there is no pre-market approval of devices. To do this, we use information received by international regulators, suppliers of devices, health care professionals and patients.

Medsafe has an important role in post-market regulation of medical devices

As with medicines, medical devices are defined in and regulated under the Medicines Act 1981. However, unlike medicines, there is no pre-market approval system for medical devices. This means that devices are not assessed by Medsafe in terms of quality, safety, efficacy or performance before they are distributed in New Zealand.

It is, however, a mandatory requirement that suppliers of medical devices notify their products to the WAND notification database. If there is a medical device safety issue, we use information in the WAND database to identify all suppliers of that device.

Medical device adverse event reports provide us with important information

A key source of information is medical device adverse event reports. These reports help us to identify potential issues with devices and to investigate and take regulatory action when needed.

Our regulatory action can result in a corrective action being implemented to address a device defect, an update to device instructions for use, publication of safety alerts on our website and recalls of devices from the market.

We don’t take direct action on every report received, however all reports are important and useful in identifying trends. In addition, there are some issues that do not need to be reported to us, for example, improper use of the device. Find out more about medical device adverse event reporting.

Anyone can report an issue relating to a medical device

Anyone can report a medical device adverse event. Reporting forms are available on our website.

If a patient reports an adverse event relating to a medical device to you, as their health care professional, we strongly encourage you to report this to us. Health care professionals are often able to provide information which can help to identify the device in question and provide clinical context.

Patient information remains confidential to Medsafe.

Additional information

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