Entering the Australia & New Zealand Markets: What Medical Device Manufacturers Need to Know

May 8, 2024

Entering the Australia & New Zealand Markets What Medical Device Manufacturers Need to Know

Australia and New Zealand are often target countries for MedTech companies looking to expand into a new market.

Due to their bilateral agreement on medical device regulation and acceptance of several overseas device certifications, the two countries may present a relatively simple regulatory pathway for many devices. 

So, for anyone considering Australia and New Zealand as the next market for their device, here’s what you’ll need to know about the regulatory landscape. 

BONUS RESOURCE: Click here to download the Essential Principles Checklist for medical devices to ensure compliance in the Australian market.

What are the regulatory bodies that govern medical devices in Australia and New Zealand?

In Australia, the Therapeutic Goods Administration (TGA) is the government entity that regulates medical devices, playing a similar role to FDA in the US. Any medical device imported into, supplied in, or exported from Australia must be registered in the Australian Register of Therapeutic Goods. 

In New Zealand, the government entity tasked with regulating medical devices is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). 

Both New Zealand and Australia use a device classification scheme similar to the European Union, with three risk levels broken up into four classifications:

  • Class I - low risk

  • Class IIa - moderate risk

  • Class IIb - moderate to high risk

  • Class III - high risk 

Regulatory pathways in Australia

In Australia, the review process for devices is expedited if a device has been given regulatory approval in certain other markets, like the US and the EU. As John Skerritt, Deputy Secretary of Health Products Regulation in the Australian Government Department of Health and Aging, said in a interview with FDA:

Medical devices are a little bit different because there's still significant divergence in the regulatory systems for medical devices compared to drugs. But that doesn't mean we still can’t refer to an FDA PMA or 510(K) regulatory review to contribute to our own review. For many years Australia has heavily relied on European device reviews by notified bodies. A couple of years ago we expanded that approach to a wider range of countries. And what that does is, it reduces the amount of review work we have to do.

The full list of comparable overseas regulators and assessment bodies that TGA recognizes consists of:

  • Notified bodies designated by the medical device regulators of European member states

  • FDA in the United States

  • Health Canada

  • Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency of Japan

  • Singapore's Health Sciences Authority (HSA)

If a device has no oversea approvals or has approvals that do not allow for an expedited review, then the device must undergo the TGA’s full conformity assessment process. 

Regulatory pathway in New Zealand

In New Zealand, medical devices must have documentation proving the device’s safety and effectiveness, which may be requested by Medsafe. All devices must be registered in Medsafe’s Web-Assisted Notification of Devices (WAND) database within 30 days of commercialization. 

Additionally, the sponsor will need to make a declaration that the following statements are true: 

  • The product is a medical device as defined in the Regulations

  • The sponsor has assigned the correct risk classification for the device

  • The sponsor will only recommend the device for its intended purpose

  • The information provided by the sponsor is accurate and complete

You can find the full regulatory requirements for medical device sponsors on Medsafe’s website. However, devices do not have to undergo an extensive review process in New Zealand if the sponsor provides all required information and meets the relevant regulatory requirements. 

What is the Trans-Tasman Mutual Recognition Agreement?

Australia and New Zealand are often grouped together as medical device markets because of the Trans-Tasman Mutual Recognition Agreement (TTMRA). The TTMRA allows medical devices that are legally supplied in one of the two countries to be legally recognized and sold in the other country without an additional regulatory process. 

Keep in mind that there are conditions and requirements that must be met for mutual recognition of a device, and you can find more information in this user’s guide to the TTMRA created by members of the Cross-Jurisdictional Review Forum from both countries. 

However, in general, the TTMRA is an effective way of making sure that life-changing medical devices can be supplied to both Australia and New Zealand without undue burden.

If my device is approved in the US or EU, what do I need to do to get it to market in Australia and/or New Zealand?

Many device manufacturers look to Australia and New Zealand as opportunities for expansion given the potential for expedited market access with FDA approval or CE marking, but it’s important to remember that there are other steps you’ll need to take to place your device on those markets. 

One point to remember is that if your company does not have a physical establishment in Australia or New Zealand, you will have to appoint a local authorized representative. This is a requirement in both countries, so if you want to market your device in both Australia and New Zealand, you will need an authorized representative in each country. 

The authorized representative is the contact between the TGA or Medsafe and the device manufacturer, and is responsible for post-market reporting and vigilance requirements.  

You can find a full list of requirements in Australia on the Australian Regulatory Guidelines for Medical Devices (ARGMD) page. For New Zealand, visit Medsafe’s Regulatory Guidance page.

BONUS RESOURCE: Click here to download the Essential Principles Checklist for medical devices to ensure compliance in the Australian market.

Greenlight Guru helps keep you compliant and audit-ready at all times

Regardless of the market you’re entering, your quality management system (QMS) will need to be up-to-date, fully traceable, and compliant. With Greenlight Guru Quality, you’ll have a QMS solution that comes aligned with EU MDR, 21 CFR Part 820, and ISO standards on quality management and risk management. In other words, you’ll have everything you need to stay audit-ready at all times. 

And when your QMS is airtight, you’ll find it’s much easier to begin expanding into new markets, as you have all the data and information you need, right at your fingertips. Ready to see how a streamlined and compliant QMS solution can make market entry that much easier? Then get your free demo of Greenlight Guru today →

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

Medical Devices Essential Principles Checklist
Download Now
Medical Devices Essential Principles Checklist - slide-in cover
Search Results for:
    Load More Results