Memo · Health & Medical Law
Memo: is this AI tool regulated software as a medical device?
Advice memo template that tests whether an AI product is a medical device under the Therapeutic Goods Act from its intended purpose and claims, works through exclusions, exemptions and classification, and notes EU and US equivalents.
- Kind
- Memo. An internal or advice memo.
- Where it applies
- Australia, European Union, United States
- AI use
- Yellow AI can help in set ways. A lawyer checks specific points before use.
- Law stated as at
- 17 October 2026
- Status
- Maintained. Checked against the cited sources on 17 October 2026.
- Version
- 1
- Source
- Written for this library
When to use it
Use when a developer, clinic or investor asks whether an AI health product needs TGA approval before supply, or when a product's features or marketing change. The answer turns on documents (labelling, instructions, advertising, technical files), so obtain them first.
How AI may be used
AI can summarise the product documents and lay out the statutory steps, but classification turns on intended purpose and claims, so a person must review the labelling, marketing and system documentation rather than infer them.
AI may
- Summarise the product description, instructions and marketing into the facts section, quoting the claims exactly.
- Map each feature to the s 41BD purposes and the TGA exclusion and exemption categories for the lawyer to assess.
- Prepare the list of documents and questions for the client.
AI must not
- Must not conclude that the product is or is not a medical device, or assign a class.
- Must not infer the intended purpose from what the product could do rather than what the manufacturer says it is for.
- Must not rely on recollection of TGA exclusions or exemptions; they must be checked in the current instruments.
The lawyer checks
- Every marketing claim, app store description and instruction has been read by a person.
- Exclusions and exemptions were checked against the current Determination and Regulations.
- Planned features (the roadmap) were considered for scope creep.
- Overseas pathways were checked with local counsel where the product is supplied abroad.
Method: how the Green, Yellow and Red levels are decided. This is guidance for planning, not legal advice.
Official form
Open the official form. Always use the current version from the issuer.
Read the full text
The full text is for signed-in accounts. It is free. When you sign in you can:
- read the whole precedent, with its drafting notes beside it;
- copy it, or download it as a Word file or Markdown;
- add it to your firm’s knowledge base, so colleagues can find it;
- let the AI tools you connect read it from that knowledge base.
The summary, the law it rests on and the AI-use guidance above stay public. Privacy.
More in Health & Medical Law
- Practitioner's response to an Ahpra notification or proposed immediate action
- Patient information and consent form for AI scribes and AI-assisted care
- Request for access to health records (patient or authorised representative), with state and NZ variants
- Open disclosure follow-up letter after an adverse event (health service)
- Memo assessing a mandatory notification obligation under the National Law
All precedents for Health & Medical Law · Tasks and AI use in this area