New Zealand Sponsor Service for Medical Devices and IVDs — Trans-Tasman Regulatory Expertise

Practical RA provides New Zealand Sponsor services for overseas manufacturers of medical devices seeking access to the New Zealand market via Medsafe, New Zealand’s medical device regulator.

Under New Zealand law, overseas manufacturers cannot supply medical devices in New Zealand without appointing a New Zealand-based Sponsor. The Sponsor holds formal legal responsibility under the Medicines Act 1981 and the Medicines (Database of Medical Devices) Regulations 2003, acts as Medsafe’s local point of contact, and is responsible for notifying devices to the Web Assisted Notification of Devices (WAND) database and managing ongoing post-market compliance obligations.

For most overseas manufacturers already holding CE Marking, US FDA clearance, or Australian TGA registration, New Zealand market entry is achievable quickly and without a formal pre-market approval process. New Zealand does not operate a pre-market approval system comparable to the EU MDR or US FDA — market access is achieved through WAND notification, supported by your existing international approvals. For manufacturers already in the Australian market, adding New Zealand is typically straightforward.

Practical RA is a boutique regulatory firm headquartered in Melbourne, Australia. We provide New Zealand Sponsor services as part of a Trans-Tasman market access offering, meaning manufacturers can establish regulatory compliance in both Australia and New Zealand through a single, coordinated engagement.

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New Zealand and Australia: A Natural Pairing

New Zealand and Australia share broadly comparable regulatory frameworks for medical devices. Both are risk-based systems with classification structures aligned with international GHTF standards. Both recognise CE Marking, US FDA clearance, and each other’s regulatory approvals as reference country documentation. Both place ongoing post-market obligations on the local Sponsor.

For overseas manufacturers, this alignment means that the documentation you have already prepared for Australian TGA registration — technical files, conformity assessment evidence, clinical documentation — largely satisfies Medsafe’s requirements as well. If you are already supplying in Australia, or in the process of obtaining TGA registration, New Zealand is a logical and low-friction next step.

Practical RA coordinates Australian and New Zealand Sponsor services in a single engagement where required, avoiding duplicated effort and ensuring consistency across your Trans-Tasman regulatory position.

What Practical RA Does as Your New Zealand Sponsor

WAND Notification and Device Listing

We prepare and submit all required information to the WAND database on your behalf, including device classification under the New Zealand Schedule 2 rules, GMDN code assignment, manufacturer and Sponsor details, and all supporting product information. Where your device is already registered in Australia, we include your ARTG number as supporting evidence.

Documentation Review

We review your existing technical documentation — CE Marking certificates, FDA clearance letters, TGA manufacturer evidence, ISO 13485 certificates, and Essential Principles compliance documentation — against Medsafe’s expectations. For manufacturers with current international approvals, this process is typically straightforward.

Ongoing Sponsor Obligations

Once your device is listed in WAND, your New Zealand Sponsor obligations continue for the product lifecycle. Practical RA manages:

WAND updates when device details change (required within 10 working days of any change)
Adverse event and incident reporting to Medsafe (final reports required within 30 days for serious incidents)
Distribution record maintenance to support recall management
Medsafe correspondence and information requests
Sponsor transfer management if your commercial arrangements change

Service Overview

Documentation Review

As your New Zealand Sponsor we ensure all your technical documentaion is aligned with Medsafe requirements, to avoid costly future penalties

WAND Notification & Regulatory Support

Support with WAND notification activities and Sponsor obligations, including Medsafe Audits and Market Actions.

Ongoing Compliance Support

Ongoing New Zealand Sponsor support to assist with regulatory responsibilities across the product lifecycle.

How the New Zealand Sponsor Appointment Process Works

For overseas manufacturers approaching the New Zealand market for the first time, the process of appointing a New Zelaand Sponsor and achieving WAND notification inclusion typically follows these stages:

Step 1 — Initial Assessment

We review your device type, classification, and existing international regulatory approvals to confirm the New Zealand pathway and identify any documentation considerations. We confirm your New Zealand device classification under Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003, which in most cases aligns with your EU or Australian classification.

Step 2 — Sponsor Agreement and Appointment

We formalise the Sponsor relationship through a written agreement defining responsibilities for both parties. Practical RA is formally appointed as your New Zealand Sponsor, and your manufacturer details are confirmed for WAND notification..

Step 3 — Documentation Review and Preparation

We review your existing technical documentation against Medsafe’s reference country requirements, confirm your GMDN code, and prepare all information required for WAND notification. For manufacturers with current CE Marking or TGA registration, this step is typically completed within one week.

Step 4 — WAND Notification

We complete and submit your device notification to the WAND database. There is no Medsafe review period or approval decision — notification is confirmed on submission, provided the entry is complete. Unlike the TGA’s ARTG process, there are no government fees associated with WAND notification.

Step 5 — Ongoing Sponsor Obligations

Once listed, Practical RA provides ongoing New Zealand Sponsor support across the product lifecycle, managing WAND updates, adverse event reporting, Medsafe correspondence, and any required corrective actions or recalls.

Tara Silva

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, unlike many larger corporations that are based entirely off-shore.

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

“New Zealand market access is a natural next step for manufacturers with overseas approval looking to enter the Australasian markets.”
Schedule a call or contact Tara directly at tara@practicalra.com

Key Differences Between New Zealand and Australian Market Access

Understanding the differences between the two frameworks helps manufacturers plan their Trans-Tasman strategy 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

Who Requires a New Zealand Sponsor?

ou will require a New Zealand Sponsor if you are:

An overseas manufacturer without a New Zealand legal entity or principal place of business
Supplying medical devices in New Zealand via a distributor or directly
Entering the New Zealand market for the first time
Changing existing Sponsor arrangements
Expanding your Trans-Tasman product portfolio

Note that 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 you are unsure whether your product requires WAND notification, this can be assessed during initial discussions.

Frequently Asked Questions

Questions we commonly receive from device manufacturers looking for their New Zealand Sponsor:

No. New Zealand operates a post-market notification system. Medical devices must be notified to the WAND database within 30 days of commercialisation — there is no formal pre-market approval or review period. Medsafe can request technical documentation at any time to verify safety and performance, but notification itself is confirmed on submission.

No. Unlike the TGA’s ARTG system, Medsafe does not charge fees for WAND device notifications or annual listing maintenance. The main costs involved are professional service fees for Sponsor appointment and ongoing compliance support.

Yes. New Zealand recognises approvals from a range of Reference Countries including the EU (CE Marking), USA (FDA clearance), Australia (TGA registration), Canada (Health Canada), and Japan (PMDA). If your device holds current approval from any of these jurisdictions, this documentation satisfies Medsafe’s technical evidence requirements.

WAND notification is confirmed on submission, provided the entry is complete and accurate. There is no Medsafe review period. For manufacturers with current international approvals and well-organised documentation, listing is typically achievable within 1 to 2 weeks of Sponsor appointment.

Yes — and for most overseas manufacturers, consolidating Trans-Tasman Sponsorship with a single provider is the most efficient approach. Practical RA provides both Australian Sponsor and New Zealand Sponsor services, coordinating ARTG and WAND obligations in a single engagement and ensuring consistency across your Trans-Tasman regulatory position.

Changing Sponsor requires cooperation between your existing and new Sponsors. The incumbent Sponsor must mark all your WAND device notifications as obsolete in their account, after which the new Sponsor resubmits the notifications under their account. Practical RA manages incoming Sponsor transfers and can advise on the process if you are looking to change from your current arrangement.

Yes — Australian and New Zealand Sponsorship are separate legal requirements under separate regulatory frameworks. Your Australian Sponsor cannot act as your New Zealand Sponsor unless they also hold a New Zealand presence and are separately appointed under the Medicines Act 1981. Practical RA holds both and can act in both roles.

You’re in good hands with the expertise of Practical RA

If you are an overseas manufacturer seeking an New Zealand Sponsor, or looking to add New Zealand to an existing Australian market presence, contact Practical RA to discuss your requirements.

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