Medical Device Registration – Australia

Before a new medical device can be supplied to the market in Australia, it must be assessed by the Therapeutic Goods Administration (TGA). The TGA’s regulatory requirements vary based on the type of device and its intended use.

Examples of Medical Devices

Medical devices:

  • Are used on humans
  • Have therapeutic benefits
  • Generally have a physical or mechanical effect on the body or are used to measure or monitor bodily functions

Medical devices range from low-risk items like bandages to high-risk products such as pacemakers. Examples include:

  • Artificial hips
  • Blood pressure monitors
  • Breast implants
  • Catheters
  • Condoms
  • Lubricating eyedrops
  • MRI scanners
  • Orthodontics (e.g., braces, fillings)

Software as a Medical Device

Software is increasingly used both as a medical device and within medical devices. Unless specifically excluded or exempt, software-based medical devices must be included in the Australian Register for Therapeutic Goods (ARTG) prior to supply. More information can be found at the TGA’s “Software as a Medical Device” resource.

TGA’s Role and Assessment Process

To maintain public confidence in the safety, performance, benefits, and risks of medical devices in Australia, the TGA conducts assessments:

  • Before a device can be supplied to the market
  • While a medical device is available on the market

The TGA is involved in most stages of a medical device’s lifecycle. The regulatory requirements depend on the device type and its use.

The DTS team can assist in determining whether a product requires registration with the TGA. They can also help modify product claims to potentially bypass the need for registration.

 

Medical Device Registration – New Zealand

 

Pre-market approval of medical devices is not necessary in New Zealand. However, market entry requires listing the product in MedSafe’s Web Assisted Notification of Devices (WAND) database within 30 days of commercialization. Before listing, ensure you have documentation proving the device’s safety and effectiveness, such as certification from the EU Notified Body, Health Canada, or the US FDA, as MedSafe may request this information.

WAND Database Notification Requirements

For a device to be legally supplied in New Zealand, it must be notified to the WAND database, which is free and incurs no ongoing fees. Notification must occur within 30 calendar days of becoming the sponsor of the device. Required information includes:

  • Risk Classification: As per Schedule 2 of the Regulations
  • Sponsor Details: Including address and contact information of the registered office or principal place of business in New Zealand
  • Manufacturer Details: Including address and contact information of the registered office or principal place of business, whether in New Zealand or overseas
  • Product Description: Defined by the Global Medical Device Nomenclature (GMDN) system

Risk Classification and Sponsorship

Medical devices are classified by potential risk from Class I (low risk) to Active Implantable Medical Device (AIMD, high risk). Sponsors must determine the correct risk classification.

Role of the Sponsor

For companies without a physical presence in New Zealand, a local Sponsor must be appointed. The New Zealand Sponsor is responsible for:

  • Maintaining the accuracy of information in WAND
  • Acting as the sole liaison to MedSafe
  • Ensuring vigilance and regulatory compliance

Conclusion

Navigating the regulatory landscape for medical devices in Australia and New Zealand involves understanding specific requirements and maintaining compliance with TGA and MedSafe regulations. Proper documentation, accurate device classification, and timely WAND notifications are crucial for market entry and legal supply.

For further assistance with medical device registration in Australia or New Zealand, contact the expert team at DTS.