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Therapeutic Goods Regulations
Australia Regulatory Strategy & Product Classification
Classification is not an administrative label. It drives the minimum conformity evidence, ARTG pathway, application-audit exposure, UDI timing and post-market obligations. NKB Regovanta reviews the intended purpose and the device characteristics that actually trigger the Australian classification rules before the market-access plan is fixed.
When This Support Is Needed
Launching a new medical device or IVD in Australia
Changing intended purpose, indications, duration of use, anatomical site or user population
Adding software functionality or converting a hardware feature into software
Introducing sterile, measuring, implantable or active functionality
Using an overseas classification as the starting point and needing to confirm whether Australian rules produce the same outcome
Building a multi-market product family where Australian grouping and evidence must be aligned early
What We Challenge Before Submission
Whether the intended purpose supports the proposed class
Whether multiple classification rules apply and the highest class has been considered
Whether accessories and software have been classified separately where required
Whether the GMDN / kind-of-device strategy matches the proposed ARTG inclusion
Whether the existing conformity evidence actually covers the Australian scope
Our Support Includes
Product qualification as a medical device, IVD, software-based medical device or other therapeutic good
Intended purpose and claims review against Australian regulatory definitions
Class I, Is, Im, IIa, IIb and III classification strategy for non-IVD medical devices
IVD Class 1, 2, 3 and 4 classification strategy under the risk-based IVD rules
Accessory, system and procedure pack considerations
Software / SaMD classification and exemption / exclusion assessment where applicable
GMDN term selection and “kind of medical device” grouping assessment
Conformity assessment route determination based on risk class
Initial UDI applicability and compliance-timing assessment
Regulatory evidence roadmap from classification to ARTG inclusion
Senior Regulatory Question:
If the intended purpose changes, does the classification still hold — and does the existing conformity evidence still cover the Australian kind of device?
Establish Your Australian Medical Device Classification
Our TGA regulatory specialists evaluate your intended purpose, map GMDN codes, and structure a compliant ARTG grouping strategy.