“Devicive”: Medical Device Regulation and the New Zealand Therapeutic Products Act 2023

Abstract

This paper analyses aspects of the Therapeutic Products Act 2023 (“Act”). The Act creates a regulatory regime that oversees medical devices, medicines, natural health products and active pharmaceutical ingredients. This paper focuses on the regulation of medical devices, asking whether the drafting of the Act reflects the guiding principle that regulation should be proportionate to benefits and risks, and whether the Act aligns New Zealand with international standards. The paper begins by considering the concept of risk and outlining the provisions that are key to the analysis of the Act. It is concluded that the Act does not sufficiently facilitate risk proportionate regulation of medical devices. The paper continues, comparing the regime created by the Act to regimes in comparable jurisdictions, which influenced and informed the recommendations made. It is found that the Act does not necessarily reflect international best practice. The paper then considers the issues and unintended consequences that the Act may create, which were highlighted in the submissions to the Select Committee. There is a danger that the importers New Zealand relies on for its medical devices skip the market entirely and a concern that the Regulator will quickly become overwhelmed. Finally, recommendations are made to address these issues, align New Zealand with international best practice and ensure that the regulation of medical devices is risk proportionate. Firstly, it is recommended that a risk-based classification system be implemented in the Act and that devices are evaluated differently based on their classification. Secondly, the role of overseas approvals in the evaluation process should be clarified, allowing sponsors of devices to use them to expedite the evaluation process. Included are draft amendment options for each recommendation. The paper finishes by considering the delegation of power under the Act and recommending that more guidance be provided in primary legislation.