Point-of-care test kits
Importation restriction in effect.
COVID-19 Public Health Response (Point-of-care Tests) Order 2021
The COVID-19 Public Health Response (Point-of-care Tests) Order 2021 came into force 22 April 2021. This order prohibits a person from importing, manufacturing, supplying, selling, packing, or using a point-of-care test for SARS-CoV-2 or COVID-19 unless the Director-General of Health has:
- authorised the person’s activity; or
- exempted the point-of-care test from the prohibition.
This order replaces the Notice Under Section 37 of the Medicines Act 1981 (Gazette 2020-go1737) and broadens the group of Point-of-care Tests the restrictions apply to.
The reason for the issuing of the Order is to prevent testing for COVID-19 using unverified or unaccredited methods or tools and prevent the misinterpretation of any results.
Information about process for applications made for authorisations under the POCT Order
Applications will be acknowledged within five working days of receipt.
Complete the application - New Zealand Ministry of Health application for approval of a POCT device
The information provided will be reviewed by a Subject Matter Expert (SME) group.
The SME group may contact applicants directly for additional information or to arrange for evaluation of the product, if required.
The SME group will provide a recommendation to the Ministry of Health which will take the following into consideration:
- the technical performance of the product
- the clinical use scenarios for the product in the New Zealand context (who can use the product and under what circumstances).
If the SME group recommends that authorisation for import/supply/use (as relevant) should be sought from the Director General of Health, the National Laboratory Testing team will seek authorisation.
The authorisation, if approved, may include some conditions around the use of the product.
Applicants will be advised on either the progress of the application, or, the outcome of the application, within 25 working days of receipt.