Notice Type
Departmental
Notice Title

Revocation and Replacement 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

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:

  1. the activities authorised in this notice will not pose a material risk to the public health response to COVID-19; and
  2. the authorisation is not inconsistent with the purpose of the Act; and
  3. 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:

  1. All laboratories accredited by International Accreditation New Zealand (IANZ) to ISO 15189 for COVID-19 testing;
  2. All District Health Boards established by section 19 of the New Zealand Public Health and Disability Act 2000;
  3. 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;
  4. New Zealand Clinical Research (NZCR);
  5. 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;
  6. 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

Manufacturer: Cepheid

Product name: Cobas Liat

Manufacturer: Roche

Product name: ID Now

Manufacturer: Abbott

Product name: Biofire FilmArray

Manufacturer: MediRay

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.