Left to Their Own Devices? The Future of Medical Device Regulation in Aotearoa/New Zealand

Medical devices encompass everything from simple bandages to complex machinery and software, and are integral to Aotearoa/New Zealand’s healthcare system. Despite this, and unlike medicines, they remain largely unregulated. Sponsors must merely complete a form indicating intention to supply; there is no pre-market safety assessment and only limited post-market controls. In this, Aotearoa/New Zealand differs from comparable countries and indeed much of the world. Despite moves towards a new regime, including consultation on a draft new Therapeutic Products Bill in 2018, details are sparse, and any change remains years away from implementation. Meanwhile, analysis of Aotearoa/New Zealand’s current approach, and potential options for change, is absent from the literature.

In this thesis, I use regulatory theory and existing literature to identify key principles for consideration in regulating medical devices. I then assess Aotearoa/New Zealand’s current approach in light of its history, finding that, despite its advantages in getting products to market, it is not fit-for-purpose, with significant questions around product safety and effectiveness, and appropriateness for present-day Aotearoa/New Zealand. As for a replacement, since any new regime will likely borrow from, and rely on, overseas regulation, I consider a range of foreign approaches and what they can teach Aotearoa/New Zealand, before making my own recommendations. Specifically, I propose a full regulatory system including an expansive definition of medical devices, a risk-based pre-market assessment system drawing on the Singaporean model of balancing overseas regulatory approvals and time spent in markets against advantages of a localised assessment (to promote safety and effectiveness while encouraging entry into Aotearoa/New Zealand’s relatively small market), plus comprehensive post-market processes.