Medical Device Regulations in Australia and New Zealand

Australia and New Zealand have a mutual recognition agreement for medical device regulation and recognize a variety of overseas device certifications, so the regulatory process is relatively simple.

In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). All medical devices imported, supplied or exported must be registered on the Australian Register of Therapeutic Supplies.

In New Zealand, medical devices are regulated by the New Zealand Medicines and Medical Devices Safety Authority (MedSafe).

Classification of Medical Devices

Medical devices in Australia and New Zealand are classified into three risk levels and grouped into four categories.

• Class I - Low risk
• Class IIa - Moderate risk
• Class IIb - Medium to high risk
• Class III - High risk

Regulatory Pathways in Australia

In Australia, the review process can be accelerated if the medical device has already received regulatory approval in other major markets, such as the United States or the European Union. The full list of TGA-accredited overseas regulators and assessment bodies includes:

• Notifying bodies designated by the medical device regulatory authorities of the European member States
• U.S. Food and Drug Administration (FDA)
• Health Canada
• Japan's Ministry of Health, Labour and Welfare and the Pharmaceutical and Medical Device Agency (PMDA)
• Health Sciences Authority of Singapore (HSA)

If a device is not approved overseas or its approval precludes accelerated review, the device must undergo the TGA's full compliance assessment process.

Regulatory pathways in New Zealand

In New Zealand, all medical device manufacturers must provide relevant documentation demonstrating the safety and efficacy of their products. MedSafe may require detailed product documentation for review. All devices must be registered in the MedSafe Web-Assisted Notification of Devices (WAND) database within 30 days of marketing.

In addition, the applicant needs to declare that the following is true:

• The product is a medical device as defined in the regulations
• The sponsor has assigned the correct risk category to the device
• The sponsor will recommend devices only for their intended use
• The information provided by the sponsor was accurate and complete

TTMRA Mutual Recognition Agreement

Australia and New Zealand are generally considered as a unified medical device market due to the Trans-Tasman Mutual Recognition Act (TTMRA). The TTMRA allows medical devices that meet certain conditions and are legally supplied in one of the countries to be legally recognized and sold in the other without additional regulatory processes.

The TTMRA is a crucial mechanism to ensure the smooth supply of medical devices in Australia and New Zealand.

How to enter the Australian or New Zealand market after being approved in the US or EU?

Many device manufacturers view Australia and New Zealand as potential expansion markets because of the potential for accelerated market access with the help of FDA approval or the CE mark. However, it is important to keep in mind that even if your device is approved in the US or EU, there are still some necessary steps to take to enter the Australian and New Zealand market.

If your company does not have an entity in Australia or New Zealand, you will need to appoint a local authorized representative before you can sell your device in these two countries. The authorized representative will serve as the liaison between the TGA or MedSafe and the device manufacturer and will be responsible for post-marketing reporting and monitoring requirements.

Australia and New Zealand, as major medical device markets, have a regulatory environment of high transparency and convenience. Through the mutually recognized TTMRA protocol and recognition of overseas certifications, companies can achieve faster product launches in these markets. Proregulations specializes in providing one-stop compliance services to global medical device manufacturers to ensure that their customers comply with the regulatory requirements of their target markets and achieve smooth business growth. If you are interested in our services or need more details, please contact us.