IVD classification in New Zealand
What is an IVD?
An in vitro diagnostic (IVD) medical device is a device intended for the examination of specimens derived from the human body — such as blood, urine, tissue, or cells — to provide information about a physiological or pathological state, a congenital abnormality, or the safety or compatibility of blood or other substances.
Examples: blood glucose meters, pregnancy test kits, HIV rapid tests, laboratory analysers, COVID-19 antigen tests.
Key point: IVDs are exempt from WAND
IVDs are listed in Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003 as exempt from mandatory WAND notification. Sponsors can voluntarily notify IVDs to WAND — and many do — but it is not required.
Despite the notification exemption, IVDs are still subject to the Medicines Act 1981 and must:
- Be safe and perform as intended
- Be labelled in accordance with GHTF guidance
- Have sponsor oversight
- Be covered by adverse event reporting obligations
IVD classification — the four classes
New Zealand uses four IVD classes (note: lower-case numbers, unlike device Classes I–III):
| Class | Risk | Examples |
|---|---|---|
| Class 1 | Lowest | General laboratory instruments, specimen receptacles, non-specific binding reagents |
| Class 2 | Low-medium | Blood glucose self-tests, pregnancy tests, general infectious disease screening |
| Class 3 | Medium-high | Blood group typing, HLA typing, HIV confirmatory tests, PSA testing |
| Class 4 | Highest | CJD screening, blood group confirmatory typing where a mismatch could be life-threatening |
How IVD classification differs from device classification
Unlike the 22-rule system for non-IVD devices, IVD classification is based primarily on:
- Intended use — what the test is for (screening, diagnosis, monitoring)
- Risk of incorrect result — what happens if the test gives a false positive or false negative
- Whether it is self-administered — home-use IVDs generally carry higher regulatory risk
- Whether it tests for life-threatening conditions — HIV, blood group incompatibility, CJD
Comparison with AU and EU
| Market | Framework | IVD mandatory registration? |
|---|---|---|
| New Zealand | Medicines (Database of Medical Devices) Regs 2003 | No — WAND voluntary for IVDs |
| Australia | Australian In Vitro Diagnostic Devices Regulations | Yes — ARTG listing required |
| European Union | EU IVDR 2017/746 | Yes — CE marking required |
This is one of the most significant areas where NZ diverges from its regulatory neighbours. Sponsors selling IVDs in both NZ and AU must meet the full TGA IVD framework for Australia, but only need to voluntarily notify (or simply maintain evidence) for New Zealand.