Published: 22 April 2020
Revised: 22 April 2021
Revised: 17 November 2021
Medical Devices
COVID-19 – point-of-care test kits: new Order restricting import, manufacture, supply, sale, packing and use
The prohibition Notice expired on 22 April 2021 and has been replaced by an Order issued under the COVID-19 Public Health Response Act 2020.
New Point-of-care Tests Order
How are medical devices regulated?
New Point-of-care Tests Order
On 22 April 2021 the section 37 Notice prohibiting the import, manufacture, supply, sale, packing or use of point-of-care test kits expired. From that date, an Order issued under the COVID-19 Public Health Response Act 2020 has taken effect. This Order has the general effect of continuing the restrictions under the section 37 Notice and broadens the group of Point-Of-Care tests the restrictions apply to.
View the COVID-19 Public Health Response (Point-of-care Tests) Order 2021
The Ministry of Health has developed a webpage to provide more information about this Order. https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-response-planning/covid-19-epidemic-notice-and-orders#poc-tests
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.. 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 have 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.
