Australia and New Zealand Sponsorship — Coordinated by One Regulatory Team

Practical RA provides combined Australia and New Zealand Sponsor services for overseas manufacturers of medical devices and IVDs seeking simultaneous or sequential access to both markets.

Australia and New Zealand represent a natural pairing for overseas manufacturers. The two markets share broadly compatible regulatory frameworks, recognise the same international approvals, and are frequently approached together as part of a broader APAC market entry strategy. Coordinating both through a single regulatory partner — one who understands both the TGA’s ARTG system and Medsafe’s WAND requirements — eliminates duplicated effort, reduces onboarding time, and gives you a single point of accountability across your Trans-Tasman regulatory position.

Practical RA is headquartered in Melbourne, Australia. We hold both Australian and New Zealand Sponsor capability, managed by the same regulatory team, under a coordinated Trans-Tasman engagement.

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Why Australia and New Zealand Work Together

For overseas manufacturers, Australia and New Zealand share more regulatory DNA than almost any other two-market combination in the world.

Both frameworks are risk-based, broadly aligned with GHTF classification principles, and structured around the same device categories. Both recognise CE Marking under EU MDR 2017/745 and US FDA clearance as reference country evidence. Both place ongoing legal responsibility on a locally-appointed Sponsor. And critically, New Zealand specifically recognises Australian TGA registration as reference country documentation — meaning that if you are already on the ARTG, or in the process of obtaining TGA registration, your New Zealand WAND notification is the most straightforward market access step you will take.

The practical result: manufacturers who pursue both markets through a coordinated engagement avoid duplicating documentation preparation, avoid managing two separate regulatory relationships across two time zones, and achieve market access in both jurisdictions faster and with less overhead than approaching them separately.

How the Two Markets Differ and Why That Matters

Understanding the structural differences between Australia and New Zealand helps manufacturers plan a Trans-Tasman strategy that sequences both markets efficiently.

Australia (TGA)

New zealand (medsafe)

Regulator

Therapeutic Goods Administration

Medsafe

Database

ARTG

WAND

Pre-market approval?

Yes — ARTG inclusion required

No — notification only

Government fees

Yes — varies depending on classification

No fees for WAND notification

Timeline to market

1 Jan 4–8 weeks (Class I–IIb)

Immediate on notification

Reference country approvals accepted

CE Marking, FDA, HSA, Health Canada, Japan PMDA

TGA CAC, CE Marking, FDA, HSA, Health Canada, Japan PMDA

IVD Regulation

Regulated — ARTG inclusion required

IVDs are exempt from WAND notification

Sponsor on product label

Yes — Sponsor name and address required

Yes — Sponsor name and address required

The key strategic insight for most manufacturers: Australia takes longer and costs more to enter, but New Zealand is almost free once you have your Australian documentation in order. Sequencing Australia first, then using your TGA registration and documentation to support New Zealand notification, is the most efficient Trans-Tasman pathway for the majority of device manufacturers.

Our Trans-Tasman Sponsor Service

What Is Included

Practical RA’s Trans-Tasman engagement covers both Australian and New Zealand Sponsor obligations under a single coordinated scope:

Australia — TGA Sponsor and ARTG

  • Australian device classification confirmation
  • Manufacturer Evidence (ME) submission to the TGA
  • ARTG inclusion application preparation and submission
  • TGA audit coordination and information request management
  • Ongoing Sponsor obligations — adverse event reporting, ME maintenance, ARTG updates, post-market compliance support

New Zealand — Medsafe Sponsor and WAND

  • New Zealand device classification confirmation under Schedule 2
  • GMDN code assignment and WAND notification preparation
  • WAND database notification and confirmation
  • Ongoing Sponsor obligations — WAND updates, adverse event reporting, Medsafe correspondence

Coordinated Across Both

  • Single onboarding process with shared documentation review
  • Consistent technical file assessment across TGA and Medsafe requirements
  • One named regulatory contact managing both jurisdictions
  • Aligned post-market processes for adverse event reporting across both regulators

How the Trans-Tasman Engagement Works

Step 1 — Combined Initial Assessment

We review your device type, classification, and existing international approvals — CE Marking, FDA clearance, MDSAP, or others — and map your pathway to both the ARTG and WAND. We confirm your Australian and New Zealand classifications, identify any documentation gaps, and provide a clear scope and timeline for both markets in a single assessment.

Step 2 — Shared Documentation Review

Where your documentation supports both applications — CE Marking certificates, technical files, clinical evidence, ISO 13485 certification, Essential Principles documentation — we review it once and apply it across both regulatory submissions. This eliminates the duplication that occurs when Australian and New Zealand engagements are run separately.

Step 3 — Australian ARTG Application

We prepare and submit your ARTG inclusion application to the TGA, managing all TGA communications and audit responses through to ARTG listing confirmation. For most Class I and Class IIa devices with comparable overseas approvals, we target application submission within two weeks of completing the documentation review.

Step 4 — New Zealand WAND Notification

Once your Australian application is underway — or simultaneously, where your existing approvals are sufficient to proceed independently — we prepare and submit your New Zealand WAND notification. For manufacturers with current TGA registration, CE Marking, or FDA clearance, WAND notification is typically confirmed within one to two weeks of Sponsor appointment.

Step 5 — Ongoing Trans-Tasman Compliance

Practical RA provides ongoing Sponsor support in both jurisdictions as agreed in your service scope. This includes post-market surveillance reporting, adverse event and incident reporting to both the TGA and Medsafe, manufacturer evidence maintenance, ARTG and WAND updates, and management of any regulatory queries, audits, or market actions in either market.

Tara Silva

Australia and New Zealand Sponsor
Program Manager

You’re in good hands

We are a boutique firm with offices in Melbourne, Australia. We have local team members who engage regularly with the TGA and Medsafe, unlike many larger corporations that are based entirely off-shore.

Our Australia and New Zealand Sponsor service is lead by Tara Silva, who joined our team from a large multi-national regulatory firm.

“Combining Australia and New Zealand registrations allows manufacturers seamless market access into two innovative and dynamic regions which are adopting new technologies at a rapdily increasing rate.”

Schedule a call or contact Tara directly at tara@practicalra.com

Using Your Existing Approvals for Trans-Tasman Market Access

The most cost-effective Trans-Tasman pathway leverages your existing CE Marking or FDA clearance across both the Australian and New Zealand frameworks.

CE Marking (EU MDR 2017/745) The TGA recognises EU Notified Body certificates and technical documentation to support ARTG inclusion under the abridged pathway. Medsafe recognises CE Marking as reference country evidence. A single CE file, assessed once, underpins both applications.

US FDA Clearance (510(k) or PMA) FDA clearance is recognised by both the TGA and Medsafe as reference country evidence. Dedicated TGA pathways exist for FDA-cleared devices, and FDA documentation satisfies Medsafe’s technical evidence requirements for WAND notification.

Existing TGA Registration If your device is already on the ARTG, New Zealand WAND notification becomes your lowest-friction market access step. Medsafe explicitly recognises TGA registration as reference country evidence, and your existing Australian Sponsor documentation satisfies Medsafe’s requirements. Practical RA can add New Zealand Sponsorship alongside an existing Australian Sponsor arrangement.

Who the Trans-Tasman Service Is For

Overseas manufacturers entering Australia for the first time If you are approaching the Australian market and want to add New Zealand in the same motion, a combined engagement is more efficient than returning to establish New Zealand separately after Australian registration is complete.

Manufacturers already on the ARTG seeking to add New Zealand If you already have TGA registration and an Australian Sponsor, adding New Zealand is a low-cost, low-friction extension. Practical RA can add New Zealand Sponsorship alongside or separately from your existing Australian arrangements.

Manufacturers changing Sponsor arrangements If you are transferring from a distributor-based Sponsor to an independent professional Sponsor in Australia, adding New Zealand Sponsorship in the same transfer process avoids a second round of regulatory administration later.

Distributors managing multi-brand portfolios Australian distributors managing multiple overseas brands who need a commercially independent Sponsor across both markets will find a Trans-Tasman engagement a more efficient structure than brand-by-brand Sponsor arrangements in each jurisdiction.

Frequently Asked Questions

Yes — Australian and New Zealand Sponsorship are separate legal requirements under separate regulatory frameworks. Your Australian Sponsor cannot automatically act as your New Zealand Sponsor. However, a single regulatory firm can hold both roles if they have the appropriate presence in each jurisdiction. Practical RA acts as both Australian and New Zealand Sponsor, managed by a single team.

Both approaches are workable, and the right choice depends on your commercial timeline and documentation readiness. For most manufacturers, Australia is the primary market and New Zealand follows. However, if you hold current CE Marking or FDA clearance, there is no regulatory reason you cannot pursue both simultaneously — WAND notification in New Zealand does not require prior TGA registration. We will recommend the most efficient sequence based on your specific situation during initial assessment.

Service fees are scoped based on device type, classification, the number of devices, and your existing regulatory approvals. Both Australian and New Zealand components are discussed transparently during initial consultation and quoted together where a combined engagement is appropriate. There are no TGA or Medsafe government fees for New Zealand WAND notification — unlike the TGA’s ARTG application fees, Medsafe charges nothing for device listing.

Yes. Practical RA manages incoming Australian Sponsor transfers and can simultaneously assume the New Zealand Sponsor role if one is not yet in place, or manage a New Zealand transfer if one is. Handling both in a single transition process is more efficient than managing separate transfers at different times.

No — this is an important difference. In Australia, IVDs are regulated by the TGA and require ARTG inclusion. In New Zealand, IVDs are currently exempt from mandatory WAND notification under Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003, though voluntary notification is possible. If your product is an IVD, we assess the regulatory requirements for both markets as part of the initial scoping discussion.

Yes. While most manufacturers pursue Australia and New Zealand together, Practical RA offers standalone New Zealand Sponsor services for manufacturers who already have Australian market access through another arrangement, or who are approaching New Zealand independently. Learn more about our New Zealand Sponsor service →

Ready to Enter Both Markets

If you are an overseas manufacturer seeking coordinated Australian and New Zealand market access, contact Practical RA to discuss your device, your existing approvals, and the most efficient Trans-Tasman pathway for your situation.

Schedule a call →