Pursuant to clause 8 of the COVID-19 Public Health Response (Point-of-care Tests) Order 2021 (“Order”), I, Robyn Shearer, Acting Director-General of Health, being satisfied that:
- the activities authorised in this notice will not pose a material risk to the public health response to COVID-19; and
- the authorisation is not inconsistent with the purpose of the Act; and
- the authorisation is no broader than is reasonably necessary to address the matters giving rise to it.
authorise the persons and classes of persons listed in Schedule 1 of this notice to import, supply, sell, distribute or use the molecular point of care test devices listed in Schedule 2 of this notice.
Schedule 1: Persons Authorised Under This Notice
Persons and classes of persons authorised under this notice are:
- All laboratories accredited by International Accreditation New Zealand (IANZ) to ISO 15189 for COVID-19 testing;
- All District Health Boards established by section 19 of the New Zealand Public Health and Disability Act 2000;
- All NZ District Health Board hospitals certified under the Health and Disability Services (Safety) Act 2001 to provide hospital care, as defined in section 4 of that Act;
- New Zealand Clinical Research (NZCR);
- Medical suppliers and distributors importing tests listed in Schedule 2 for the sole purpose of supply, sale or distribution of the tests directly to District Health Boards or an IANZ ISO 15189 accredited laboratory;
- New Zealand Defence Force (NZDF).
Schedule 2: Tests Permitted to be Imported, Supplied, Sold, Distributed or Used by Authorised Persons
Point-of-care molecular test
Product name: GeneXpert
Product name: Cobas Liat
Product name: ID Now
Product name: Biofire FilmArray
Product name: VitaPCR
Manufacturer: Credo Diagnostics
Note: This notice revokes and replaces “Authorisation of Persons to Import, Supply, Sell, Distribute, and Use Certain Molecular Point-of-Care Tests Under the COVID-19 Public Health Response (Point-of-care Tests) Order 2021” published in the New Zealand Gazette, 4 March 2022, Notice No. 2022-go784.
Dated at Wellington this 1st day of June 2022.
ROBYN SHEARER, Acting Director-General of Health.