TTMRA and Australia
What is the TTMRA?
The Trans-Tasman Mutual Recognition Arrangement (TTMRA) is a treaty between Australia and New Zealand that enables goods lawfully sold in one country to be sold in the other without needing to meet the other country's specific regulatory requirements.
For medical devices, this principle has important — but limited — practical implications.
How TTMRA applies to medical devices
If a device is lawfully supplied in Australia (i.e., it has a valid ARTG listing from the TGA), the TTMRA generally allows it to be supplied in New Zealand without separately meeting NZ regulatory requirements.
This means:
- A device with a TGA ARTG listing can generally be supplied in NZ under TTMRA
- The TGA listing serves as evidence of compliance with safety and performance requirements
- The NZ WAND notification obligation still applies — TTMRA does not override WAND
WAND notification still required
The TTMRA does not exempt devices from WAND notification. Even if a device is TGA-listed and supplied under TTMRA principles, the NZ Sponsor must still notify the device to WAND within 30 days.
In the WAND entry, the Sponsor can reference the ARTG number — this is an optional field in WAND that many sponsors use to link their NZ and AU records.
Practical implications for ANZ market strategy
For manufacturers targeting both Australia and New Zealand simultaneously:
| Step | Australia | New Zealand |
|---|---|---|
| Market entry mechanism | TGA ARTG listing | WAND notification |
| Pre-market assessment | Yes — TGA assesses | No — notification only |
| Local representative | Sponsor (can be importer/distributor) | Sponsor (NZ entity required) |
| Conformity evidence | Formal conformity assessment routes | TGA ARTG = accepted evidence |
| Annual maintenance | ARTG maintenance | WAND updates as needed |
Many manufacturers use a single NZ/AU Sponsor (their distributor) to manage both the Australian ARTG and NZ WAND obligations.
TTMRA and the Medical Products Bill
Once the Medical Products Bill introduces formal device approval requirements in NZ, the TTMRA's practical relevance for devices may increase — a TGA-listed device could automatically qualify for NZ approval under TTMRA principles, potentially without a separate NZ application. This is not yet confirmed but is an area to watch as the Bill develops.
Classification differences to watch
Despite the close regulatory relationship, NZ and AU classification rules have diverged since Australia aligned with the EU MDR (2017/745) classification changes. A device that is Class IIa in NZ may be Class IIb in Australia under the updated TGA rules. Always verify classification separately for each market.