From 22 April 2020, the importation, manufacture, sale, supply and use of COVID-19 point-of-care test kits and materials is prohibited, unless authorised by Medsafe.
Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products, including devices in New Zealand.
What are COVID-19 point-of-care (POC) test kits?
COVID-19 point-of-care (POC) test kits use a blood sample to detect antigens or antibodies in the blood. There is concern internationally about the accuracy of POC test kits and the potential for them to be misinterpreted or provide a misleading result. The research to date indicates that these tests are not suitable for diagnostic purposes and have poor reliability. However, work on the accuracy and reliability of this type of test is currently being done.
There are currently no COVID-19 POC test kits that can be sold or supplied in New Zealand.
Who does the restriction apply to?
This restriction applies to importers, manufacturers, suppliers, healthcare professionals and the public. It does not apply to kits or other test materials imported by, or supplied to, the Institute of Environmental Science and Research, or an alternate approved by Medsafe.
What is the penalty for breaching the restriction?
The penalty for breaching this requirement is, on successful prosecution:
- a period of imprisonment not exceeding 3 months,
- or a fine not exceeding $500, and
- if the offence is continuing, a fine not exceeding $50 per day for every day the offence continues.
COVID-19 – point of care test kits: restriction on importation, manufacture, supply and use Medsafe, NZ, April 2020