The New Zealand (NZ) Associate Minister of Health announced the intent to repeal the Therapeutic Products Act 2023 (TPA), which otherwise would come into force this year, with most provisions taking effect on September 1, 2026. On May 23, the Associate Minister also released a lightly redacted Cabinet paper and decision meeting minutes outlining the rationale behind the Ministry decision.
Developed over nearly a decade, the TPA would have created a new regulatory agency and brought sweeping changes to the NZ regulatory framework for medical devices. With the TPA now slated for repeal, the NZ Medicines and Medical Devices Safety Authority (MedSafe) will continue to act as the medical device regulator for the foreseeable future.
New government, old medical device regulation
Repealing the TPA has been a shared objective of the three-party coalition government since defeating the incumbent Labour Party government in November of last year. Although dissatisfaction with the current regulatory regime under the 43-year-old Medicines Act and associated regulations is widespread, the TPA has drawn criticism from industry and consumers alike due to increased costs and the perception of overregulating low-risk health products.
Compared to neighboring market Australia, medical devices are loosely regulated in NZ, with few pre-market requirements to be met beyond in-country representation and notification in the Web Assisted Notification of Devices (WAND) database. Notably, no evidence of conformity assessment is required for notification of medical devices in the WAND database or to place products on the NZ market, regardless of risk classification.
Appropriate regulations for the risk
New Zealanders agree with the need for modernized health product regulation with oversight proportionate to product risk. New legislation replacing the TPA is expected to be initiated before the end of the year. However, specific policy details or an anticipated timeframe for legislative review are unavailable at this time.
New Zealand to Repeal Therapeutic Products Act 2023 | Emergo by UL
New Zealand to Repeal Therapeutic Products Act 2023
The New Zealand Associate Minister of Health announced the government’s intent to repeal the Therapeutic Products Act 2023, which otherwise would come into force this year.
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