In vitro diagnostic devices need a robust regulatory framework
Geoffrey Ce Herd, Samarina Ma Musaad1
1Chemical Pathologist and Point of Care Testing Pathologist, Waitematā, LabPlus Te Toka Tumai and Northland Te Tai Tokerau; Clinical Lead Chemical Pathology LabPlus, Auckland Hospital, Auckland; Clinical Lead Northern Region Point of Care Testing Network; Chair New Zealand Point of Care Testing Advisory Group.
Aims:
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Act 1981 related to point-of-care testing (POCT) in vitro diagnostic (IVD) devices, the implications of the now repealed Therapeutic Products Act 2023 and the regulatory requirements which will be needed in the proposed Medical Products Bill.
Methods:
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 proposed Medical Products Bill and published literature on regulation for POCT devices in New Zealand and overseas.
Results:
IVD devices are not regulated under the Medicines Act 1981. Faulty devices have been supplied to health services and direct to the public. New Zealand is currently behind international regulatory standards. Cabinet papers and the proposed Medical Products Bill state that IVD devices should be regulated and subject to a risk classification system.
Conclusion:
A comprehensive regulatory framework for POCT IVD devices is required to ensure the supply of high-quality devices to health services and consumers. The proposed Medical Products Bill must include a regulatory framework for POCT IVD devices in the interests of patient safety. Implemented wisely, the advantages of regulation outweigh disadvantages.
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