Published: 22 April 2020

Medicines

COVID-19 – point of care test kits – restriction on importation, manufacture, supply and use

This prohibition will remain in place until 22 April 2021.

 

What are COVID-19 point of care test kits?
What restrictions are being imposed?
Which COVID-19 point of care test kits can now be sold or supplied in New Zealand?
How are medical devices regulated in New Zealand?

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.

What are COVID-19 point of care 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.

What restrictions are being imposed?

POC test kits are regulated under the Medicines Act 1981 as medical devices. Section 37 of the Act allows the Minister of Health (or his delegate) to place restrictions on the importation, manufacture, sale, supply and use of specified medical devices.

Medsafe, as the Minister’s delegate, has issued a section 37 notice to prohibit these activities. From 22 April 2020, the importation, manufacture, sale, supply and use of COVID-19 POC test kits and materials is prohibited, unless authorised by Medsafe.

The penalty for breaching this requirement is, on successful prosecution:

  • a period of imprisonment not exceeding three 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.

This restriction applies to importers, manufacturers, suppliers, health care 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.

Read the section 37 gazette notice

Which COVID-19 point of care test kits can now be sold or supplied in New Zealand?

There are currently no COVID-19 POC test kits that can be sold or supplied in New Zealand.

If this situation changes, the names of any POC test kits authorised by Medsafe will be listed here.

How are medical devices regulated in New Zealand?

Medical devices (including COVID-19 test kits) in New Zealand are not assessed and approved by Medsafe before they can be supplied and used. That is, Medsafe does not conduct a pre-market assessment or issue an approval notice. However, as a consequence of the issuing of the section 37 notice, this situation does not apply to these POC test kits.

There is a requirement for most medical devices to be notified to the Web-Assisted Notification of Devices (WAND) database, operated by Medsafe. This is not compulsory for in vitro diagnostic (IVD) devices, including POC test kits, although is strongly encouraged by Medsafe.

WAND is not an approval database. It holds information about medical devices supplied in New Zealand that has been self-notified by the New Zealand manufacturer/importer of the device. The information on WAND is not publicly visible.

As the pre-market legislative/regulatory requirements are minimal, this places even more responsibility on the manufacturer/importer to ensure the medical devices supplied are safe and effective.

Medsafe's advice on the regulation of medical devices and links to instructions on notifying to the WAND database

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