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, Dr Ashley Bloomfield, the 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 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

Product name: SAMBA II SARS-CoV-2 Test, SAMBA II SARS-CoV-2/RSV Test and SAMBA II SARS-CoV-2/FluA/FluB Test

Manufacturer: Diagnostics for the Real World

Note: This notice revokes and replaces “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” published in the New Zealand Gazette, 2 June 2022, Notice No. 2022-go2190.

Dated at Wellington this 8th day of July 2022.

Dr ASHLEY BLOOMFIELD, Director-General of Health.