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January 21, 2026
Approximately 5 minutes
Determining If Your Product Is a Medical Device Requiring ARTG Inclusion – TGA Guidance
Determining If Your Product Is a Medical Device Requiring ARTG Inclusion – TGA Guidance
Legal Definition of a Medical Device
Under section 41BD of the Therapeutic Goods Act 1989, a medical device is defined as any instrument, apparatus, appliance, material, or other article (including software) intended by the manufacturer to be used for human beings for purposes such as diagnosis, prevention, monitoring, treatment, alleviation of disease/injury/disability, investigation/replacement/modification of anatomy or physiological process, or control of conception, and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means (but may be assisted by such means). Source: Determining if your medical device should be in the ARTG - TGA
Step-by-Step Decision Process
The TGA outlines a logical sequence to assess whether inclusion in the ARTG is required:
- Intended Purpose – Examine the manufacturer's stated intended use (from labelling, instructions, advertising, technical documentation). If the intended purpose aligns with the medical device definition, proceed.
- Principal Intended Action – Determine if the main effect is achieved by physical/mechanical means or energy (qualifying as a device) versus pharmacological/immunological/metabolic action (generally a medicine, not a device).
- Exclusions and Borderline Cases – Certain products are excluded even if they meet the definition (e.g., goods specified in regulations, human tissues/organs, blood/blood components). Borderline products (e.g., some cosmetics, food supplements, or software) require case-by-case assessment.
- Specific Product Types – Special rules apply to:
- Software as a medical device (SaMD)
- In vitro diagnostic (IVD) medical devices
- Custom-made devices
- Systems or procedure packs
- Accessories to medical devices
- ARTG Inclusion Requirement – If the product is a medical device and not excluded, it must be included in the ARTG (with conformity assessment evidence) before supply in Australia, unless exempt or subject to special access provisions.
Practical Assessment Tips
- Review all manufacturer claims consistently across all materials.
- Consider how the product is presented to users (not just technical function).
- For borderline cases, consult the TGA's decision trees, examples, and borderline products guidance.
- IVD medical devices follow a separate but similar decision framework focused on in vitro diagnostic purposes.
Consequences of Incorrect Classification
Misclassifying a product as non-medical (when it is) can lead to supply without ARTG inclusion, resulting in regulatory action, product removal, or penalties.
The TGA provides interactive decision trees, detailed examples, borderline product tables, and specific guidance for software and IVDs to assist manufacturers and sponsors in correctly determining ARTG requirements. Source: Determining if your medical device should be in the ARTG - TGA
Accurate classification is essential for regulatory compliance and timely market access in Australia.
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