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FDAnews Device Daily Bulletin

New Zealand Updates Plan to Boost Surgical Mesh Safety

June 19, 2017

New Zealand’s government released an updated action plan to boost the safety of surgical mesh, prompted by adverse events linked to the device in recent years.

Currently, Medsafe, the New Zealand medicines and medical devices safety authority, simply monitors the safety of devices based on adverse event reports. Now, however, the government plans to introduce premarket assessment of medical devices, as part of comprehensive regulatory framework to regulate all therapeutic products, including medical devices.

Other changes the New Zealand government is supporting include a review of best practices around informed consent for mesh procedures, and better reporting of adverse events.

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