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New Zealand to Revamp Medical Device Regulations

September 25, 2015

Bold changes could be coming to New Zealand’s medical device market as the government maps out regulatory reforms roughly a year after the collapse of a long-anticipated trans-Tasman regulatory authority.

The proposed update, still in the preliminary stages, is intended to replace the Medicines Act of 1981 with a new framework that ensures the safety of all devices while enhancing innovation.

The Ministry of Health is expected to introduce a bill in Parliament next year outlining the planned reforms.

Last November, Australia and New Zealand scrapped plans for a joint devices and drugs authority, but promised continued cooperation on mutually beneficial regulations. The announcement followed three years of work to establish the Australia New Zealand Therapeutic Products Authority, following an earlier halt when New Zealand’s legislature failed to pass implementing legislation. — Elizabeth Hollis