Before supplying a medical device in Australia or New Zealand, sponsors must comply with strict regulatory requirements designed to ensure safety, performance, and quality. DTS Regulatory Consultants assists companies in navigating these processes — from determining classification to managing submissions and sponsor responsibilities.
In Australia, all medical devices must comply with the Therapeutic Goods Administration (TGA) regulatory framework. A device must generally be included in the Australian Register of Therapeutic Goods (ARTG) before it can be supplied commercially. The TGA’s requirements depend on the intended purpose and risk classification of the device.
Medical devices are products that:
Are intended for use on humans
Provide a therapeutic benefit
Usually act through physical, mechanical, or diagnostic means rather than pharmacological action
Examples include:
Bandages • Artificial hips • Blood pressure monitors • Breast implants • Catheters • Condoms • Lubricating eye drops • MRI scanners • Orthodontic devices (e.g., braces, fillings)
Software can itself be a medical device or a component within one.
Unless specifically excluded or exempt, software-based medical devices must be included in the ARTG before being supplied in Australia.
For further reference, see the TGA resource: Software as a Medical Device (SaMD).
The TGA ensures that all devices supplied in Australia meet standards for safety, performance, and risk–benefit balance. Assessments may occur:
Before supply – pre-market evaluation and ARTG inclusion
After supply – post-market monitoring, vigilance, and recalls
The regulatory pathway depends on both device class and intended use. DTS Regulatory Consultants can help you:
Determine whether your product meets the TGA definition of a medical device
Identify the appropriate risk classification and regulatory pathway
Adjust product claims or positioning where possible to simplify or avoid TGA registration
Unlike Australia, pre-market approval is not required for medical devices in New Zealand. However, all devices must be notified to MedSafe’s Web-Assisted Notification of Devices (WAND) database within 30 days of first supply. Before notification, sponsors should hold evidence of the device’s safety and performance, such as certification from:
EU Notified Bodies
Health Canada
U.S. FDA
MedSafe may request this documentation at any time.
WAND notification is free of charge and must be completed within 30 calendar days of becoming the device’s New Zealand sponsor.
Information required includes:
Risk Classification: According to Schedule 2 of the Regulations
Sponsor Details: Address and contact information for the registered office or principal place of business in NZ
Manufacturer Details: Registered office and contact information (domestic or overseas)
Product Description: Defined using the Global Medical Device Nomenclature (GMDN) system
Medical devices are classified from Class I (low risk) to Active Implantable Medical Device (AIMD, high risk).
The sponsor must correctly determine and document the classification. If your company does not have a physical presence in NZ, you must appoint a local sponsor. The sponsor acts as the primary regulatory contact with MedSafe and is responsible for:
Maintaining accurate WAND information
Managing regulatory correspondence and vigilance
Ensuring ongoing compliance with MedSafe requirements
Our consultants provide end-to-end support for both TGA and MedSafe requirements, including:
Regulatory strategy and classification advice
Preparation of ARTG applications and WAND notifications
Sponsor appointment and compliance management
Claim reviews to align with Australian and New Zealand advertising codes
