In vitro diagnostic devices need a robust regulatory framework.
PMID: 41264823 · 2025
JournalThe New Zealand medical journal
Year2025
PMID41264823
Abstract
To discuss the regulatory scope of Medicines Act 1981 related to point-of-care testing (POCT) in vitro diagnostic (IVD) devices, the implications of the now repealed Therapeutic Products Act 2023 and the regulatory requirements which will be needed in the proposed Medical Products Bill. This review includes the relevant sections on regulation of IVD devices under the Medicines Act 1981, the role of Medsafe, the relevant sections of the Therapeutic Products Act 2023, the cabinet papers on the pro
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