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Learn how Australia and New Zealand manage their medical device frameworks regarding regulatory compliance.

Medical Device Regulatory Frameworks: New Zealand vs. Australia

14 mins

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To better understand how the medical device frameworks of Australia and New Zealand function in practice, it is essential to examine the regulatory agencies, instruments, and registration requirements in each country.

While the Trans-Tasman Mutual Recognition Arrangement (TTMRA) between the Commonwealth and states of Australia and New Zealand supports the free movement of goods between the two countries-regardless of differences in standards or other regulatory requirements related to sale-certain conditions must be met to leverage this agreement, and some laws (including specific international obligations) are exempt from the TTMRA’s application. A Users’ Guide to the Mutual Recognition Agreement (MRA) and the Trans-Tasman Mutual Recognition Arrangement (TTMRA) provides additional valuable information. 

Comparing Australian and New Zealand Medical Device Frameworks

In this article, we provide an overview of the similarities and differences in the regulatory frameworks for medical devices in New Zealand and Australia. 

Regulatory Agencies, Instruments, Registrations and Notifications

Despite efforts to create a single regulator (the Australia New Zealand Therapeutic Products Agency (ANZTPA)) within the Australian and New Zealand markets, medical device frameworks, both Australia and New Zealand maintain their own therapeutic product regulatory agencies, the Therapeutic Goods Administration (TGA) and Medsafe, respectively. 

The primary regulatory frameworks established in each market are outlined below: 

Australia New Zealand 
Therapeutic Goods Act 1989 Medicines Act 1981 
Therapeutic Goods (Medical Devices) Regulations 2002
Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025		Medicines Regulations 1984 
Medicines (Database of Medical Devices) Regulations 2003 
Therapeutic Goods Advertising Code Medicines Regulations 1984 (Part 3) 

The regulations and legislation listed in the above table are not the only regulatory guidance in each respective market, however they are the main frameworks that broadly impact all medical device manufacturers. There are specific regulations and additional guidance for certain medical devices, such as the Health (Needles and Syringes) Regulations 1998, which controls the sale and supply of needles and syringes in New Zealand. Devices which are also consumer products fall within the jurisdiction of other regulatory agencies, such as the Australian Competition and Consumer Commission (ACCC), who have established their own regulations and safety standards for certain consumer products. A list of key legislation applicable for certain devices is published on the Medsafe website. 

The Australian regulatory framework is largely aligned with the EU MDR / IVDR, albeit established under a single regulation, and applies the same concepts relating to conformity assessment, rule-based device classification, quality management system, post-market surveillance, and technical documentation requirements. Additionally, all devices to be imported or distributed in Australia must submit an application for inclusion on the Australian Register of Therapeutic Goods (ARTG) prior to marketing, and all related ARTG listings are subject to annual charges for maintenance on the register. 

In contrast, the regulatory framework for medical devices in New Zealand is relatively “light” compared to that of Australia, with minimal requirements. All medical devices intended for marketing in New Zealand must be listed in the Web Assisted Notification of Devices (WAND) database within 30 business days of market entry (the User Guide for WAND provides guidance for listing). However, several types of devices are exempt from notification to WAND, including in vitro diagnostic medical devices (IVDs). Once notified to WAND, devices are not subject to annual maintenance fees for inclusion in the database. 

Authorized Representatives & Their Obligations 

Manufacturers not located in Australia or New Zealand must nominate local authorized representatives in each jurisdiction, referred to as a “Sponsor” in both markets. For both Australia and New Zealand, the Sponsor may either import directly or arrange for an agent to import and distribute the devices. Each Sponsor is required to notify and register the devices, therefore it is often times easier to appoint an independent Sponsor who can “arrange the importation of” devices through the various importers and manage a single listing (ARTG for AUS or WAND for NZ).  

If a manufacturer is physically located in either Australia or New Zealand, a third-party Sponsor is not required. 

The obligations of Sponsors in each market include: 

 Australia New Zealand 
To ensure that the device is safe for its intended purpose. To ensure that the device is safe for its intended purpose. 
To submit applications to the TGA for inclusion on the ARTG. To list medical devices in the WAND database and maintain the listing accordingly.  
To submit applications for variation of ARTG entries when there are changes in the information registered with the TGA. To ensure the information notified to the WAND database is accurate and up-to-date, changes to information should be updated within 10 working days.
To maintain distribution records of the devices supplied, in order to quickly contact all affected users in the event of a recall or corrective action. To maintain distribution records of the devices supplied, in order to quickly contact all affected users in the event of a recall or corrective action.  
To advise TGA of any recall or corrective action affecting medical devices supplied by that sponsor in Australia, in accordance with the Procedure for Recalls, Product Alerts and Product Corrections (PRAC). To immediately advise Medsafe of any recall or corrective action affecting medical devices supplied by that sponsor in New Zealand. Guidance on the recall procedure is contained in the New Zealand Medicines and Medical Devices Recall Code. 
To ensure that the device complies with the Essential Principles, including compliance with labeling requirements.  To ensure that the labeling of the medical devices complies with the Regulations.  
To ensure that any advertising for medical devices supplied by that sponsor complies with the requirements of the Therapeutic Goods Advertising Code.  To ensure that any advertising for medical devices supplied by that sponsor complies with the requirements of the Medicines Act and Regulations.  
To ensure that TGA is notified within 24 hours after becoming aware of (a substantial risk of) the actual or potential tampering of a device. To ensure any issues associated with a medical device are reported appropriately. 
To allow access to their premises in relation to goods included on the ARTG or for which an Australian conformity assessment certificate has been issued. N/A
Ensure that the sponsor’s name and address are provided with devices in such a way that a user of the device can readily identify the sponsor, and that these details are in accordance with the Regulations. Ensure that all medical devices are clearly labeled with the name of the manufacturer or the name of the manufacturer’s distributor (i.e. sponsor) in order to comply with the regulations.  
Ensure that appropriate conformity assessment evidence is available for all devices included on the ARTG. N/A

Device Conformity Assessment & Technical Documentation 

As mentioned above, the Australian regulatory framework is very similar to the EU regulatory framework, wherein it includes several routes to conformity, with specific conformity assessment requirements for each route. Additionally, conformity assessment evidence (referred to as “Manufacturer Evidence” in Australia) can be leveraged from other jurisdictions for which the TGA recognizes the respective regulatory authorities as ‘comparable.’ Such evidence includes appropriate marketing authorizations, approvals or registrations, together with QMS certification (including certification under the Medical Device Single Audit Program (MDSAP)) from the following markets:  

  • Canada 
  • EU 
  • Japan 
  • Singapore 
  • USA 

Manufacturers must draw up an Australian Declaration of Conformity for their devices, with this serving as the Manufacturer Evidence in the case of self-certified devices. EU Declarations of Conformity cannot be leveraged for this purpose in Australia. For manufacturers without an accepted market authorization from a comparable regulator, a TGA-issued CAC can be obtained. Prior to submission of the ARTG listing, medical devices must undergo conformity assessment in Australia, which is similar to a review by an EU Notified Body, in order to obtain a CAC.  

Many manufacturers consider entry into Australia after obtaining CE marking for the EU. They typically leverage their EU technical documentation file for ARTG listing (and sometimes for WAND listing in New Zealand to demonstrate device safety and performance), but with the following modifications:

  • Inclusion of the Australian Declaration of Conformity. 
  • Inclusion of an Australian Essential Principles Checklist or equivalent documentation. 
  • Where the device is subject to any additional device-specific Australian regulatory requirements, manufacturers must provide evidence of compliance.
  • Labeling compliant with Australian requirements.

There are no conformity assessment procedures established under the New Zealand regulatory framework; however, sponsors do need to ensure that there is adequate evidence available from the manufacturer to demonstrate the safety and performance of the device. According to current guidance provided by Medsafe, current certificates issued by a European Notified Body, Health Canada, TGA, or FDA attesting compliance with medical device directives and/or standards is sufficient. 

For New Zealand, there are also specific labeling requirements, and there may be other device-specific regulatory requirements for which conformity evidence does need to be generated, including compliance with the: 

Device Labeling Within Australia and New Zealand Medical Device Frameworks

Australian labeling content requirements are largely aligned with those established under the EU regulatory framework, with the following key exceptions: 

  • The sponsor’s name and address must be provided with the device in such a way that users can readily identify the sponsor. 
  • For a medical device that is software or incorporates software, the current version number and build number must be accessible to and identifiable by users of the device. 
  • The TGA does not officially recognize harmonized symbols (e.g., ISO 15223-1:2016), although these symbols are often used in practice. Therefore, any symbols used in the labeling must be defined in the IFU.

The TGA’s UDI (Unique Device Identification) regulatory framework came into effect on 24 March 2025. Manufacturers may voluntarily comply with UDI requirements—including submission to the Australian UDI Database (AusUDID)—until the compliance start date for their medical device(s). Timelines for compliance are established under the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 and are being introduced in a staged approach, similar to other markets with UDI requirements. 

In contrast, New Zealand has not established UDI requirements. Medical device label content requirements are minimal, typically limited to the name of the manufacturer or the manufacturer’s distributor. There are also no explicit regulatory requirements in New Zealand for instructions for use (IFUs); however, the regulator expects all medical devices to be supplied with appropriate IFUs. Medsafe refers to the Global Harmonization Task Force (GHTF) guidance (GHTF/SG1/N43:2005) for labeling and IFUs, and it allows for the provision of electronic IFUs (e-IFUs). However, the sponsor must be able to provide a hard copy of the IFU upon request from a user. 

Both Australia and New Zealand have their own respective advertising requirements for therapeutic goods, established under the Therapeutic Goods Advertising Code and Medicines Regulations 1984 (Part 3), respectively.  

Post-Market Surveillance & Vigilance Obligations

As we have also covered in a separate blog article here, the TGA has established specific post-market surveillance (PMS) and vigilance requirements in Australia. Medsafe does not have any PMS requirements; however, it has also established requirements for the reporting of certain incidents and recalls. These requirements compare as follows: 

Australia New Zealand 
Reportable Incidents 
Reported through the Medical Device Incident Reporting system. Reported by submitting the Adverse Event Report (Industry) form to devices@health.govt.nz.  
Where the event represents a serious threat to public health, it should be initially reported 48 hours after becoming aware of the event or occurrence. N/A
Where the event leads to death or a serious deterioration in the state of health, of a patient, a user of the device, or another person, it should be initially reported 10 days after becoming aware of the event or occurrence. Death and Serious Injury (or possible death and serious injury): Initial report within 10 calendar days and submission of final report once the investigation has been completed. 
Where an event, occurrence or recurrence which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person, it should be initially reported 30 days after becoming aware of the event or occurrence. Minor injury (If there could be a market action as a result of the incident): Initial report within 10 working days and submission of final report within 120 calendar days (an initial report is submitted if the final report is not available at 120 days). 
Quality issue (If there could be a market action as a result of the incident): Initial report within 10 working days, For all other quality issues, the sponsor must submit a final report within 120 calendar days.  
Information regarding the status of any internal manufacturing investigation is expected to be shared with the TGA at regular intervals, and no less than every 30 calendar days. This also includes the provision of any additional information that was unavailable during submission of the initial report. N/A
Sponsors must submit a final report within 120 calendar days of the submission of an initial report at which point in time the TGA expects that manufacturers have had sufficient time to complete a detailed investigation of the reported event and identify any relevant root causes and corrective actions that were taken. The final report must also include information about ‘similar events’ for which similar events over the previous three years must be described. Final report for minor injury and quality issues within 120 calendar days. 
Market Actions / Recalls 
Requirements established under the Procedure for Recalls, product Alerts and product Corrections (PRAC). Requirements established under the New Zealand Medicines and Medical Devices Recall Code. 
TGA directs sponsors to immediately instruct its customers to quarantine affected goods, confirm that customers have notified impacted surgeons or clinicians (where applicable) as well as other areas who may have received the goods, prior to contacting the TGA for instructions when such problems relate to: 
– Imminent and significant risks to patient lives or public health 
– Actual or suspected tampering
– Radiopharnaceuticals 
– Blood or blood components 
– Biological or human tissue 
– Clinical trials 		All recall and non-recall actions must be reported to Medsafe as soon as possible, and prior to initiation. 
The TGA does require periodic updates on the progress of the market action taken, prepared using the reporting templates included in the agreement letter, typically at 6 weeks (interim) and 12 weeks (closeout) after the action has been initiated (although other reporting timeframes can be agreed with the TGA). Should additional time be necessary to complete the market action, a valid reason will need to be provided to the TGA, with further reports to be provided at a frequency determined by the TGA. Medsafe does require progress reports on the implementation of the recall action with the timing of these reports agreed with Medsafe, but normally at two (initial report) and six-week (follow-up report) intervals after initiation of the recall activity, and at other times as requested. 
The timeframe for submission of the final report should be agreed at the time the recall action is initiated but may need to be reviewed. A default timeframe of three months is proposed by Medsafe.
Additionally, for medical devices which are also consumer goods, within 10 days of agreement, the sponsor must notify the Australian Government Minister for consumer safety, where there has been overseas supply, and the ACCC must be notified of all market actions taken within two days of receiving a TGA agreement letter where the medical device is also a consumer good. N/A

Additionally, while there are annual reports required for the first three years following inclusion on the ARTG for the following devices, there are no such annual reporting requirements applicable for any devices in New Zealand: 

  • Class III devices 
  • Implantable Class IIb devices 
  • Class 4 in vitro diagnostic medical devices (IVDs) 

Learn More About the Australian and New Zealand Medical Device Regulatory Frameworks with MedEnvoy 

This article provides an overview of the similarities and differences between the Australia and New Zealand medical device frameworks for manufacturers to consider when assessing commercial entry into these markets. MedEnvoy’s regulatory experts can assist manufacturers in staying compliant with the respective regulatory requirements. Furthermore, MedEnvoy provides Australian Sponsor and New Zealand Sponsor services. Please reach out should you need assistance by clicking here, and for information about our regulatory experts click here. 

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