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:
- 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 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
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.