---
title: "Memo: is this AI tool regulated software as a medical device?"
url: "https://ailawframework.com/precedents/health-and-medical-law/ai-medical-device-regulatory-memo"
type: "precedent"
site: "AI Law Framework"
id: "a32-ai-medical-device-regulatory-memo"
area_id: "A32"
kind: "memo"
ai_level: "yellow"
version: 1
law_stated_as_at: "2026-10-17"
---

# 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…

Canonical page: https://ailawframework.com/precedents/health-and-medical-law/ai-medical-device-regulatory-memo  
Law stated as at: 2026-10-17

Site index for agents: https://ailawframework.com/llms.txt

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.

## Key facts

- Kind: Memo. An internal or advice memo.
- Practice area: [Health & Medical Law](https://ailawframework.com/precedents/health-and-medical-law.md)
- Jurisdictions: Australia, European Union, United States
- AI level: Yellow. AI can help in set ways. A lawyer checks specific points before use.
- Law stated as at: 2026-10-17
- Status: Maintained. Checked on 2026-10-17 against the 9 authorities it cites, for Australia, European Union and United States.

## 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.

## Authorities

- [Therapeutic Goods Act 1989 (Cth) s 41BD (meaning of medical device; intended purpose from labelling, instructions, advertising and technical documentation)](https://www.legislation.gov.au/C2004A03952/latest/text)
- [Therapeutic Goods (Medical Devices) Regulations 2002 (Cth) Sch 2 Pt 4 (classification rules for programmed, programmable and software medical devices)](https://www.tga.gov.au/resources/legislation/therapeutic-goods-medical-devices-regulations-2002)
- [Therapeutic Goods (Excluded Goods) Determination 2018 (Cth) Sch 1 (excluded software)](https://www.tga.gov.au/resources/legislation/therapeutic-goods-excluded-goods-determination-2018)
- [Therapeutic Goods Legislation Amendment (2026 Measures No. 1) Regulations 2026 (Cth) (amended CDSS exemption, Sch 4 item 2.15, from 1 November 2026)](https://www.legislation.gov.au/F2026L01167/latest/text)
- [TGA, Artificial intelligence (AI) and medical device software regulation (updated 5 February 2026)](https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence-ai/manufacturing/artificial-intelligence-ai-and-medical-device-software-regulation)
- [Regulation (EU) 2017/745 (Medical Device Regulation) Annex VIII rule 11](https://eur-lex.europa.eu/eli/reg/2017/745/oj)
- [Regulation (EU) 2024/1689 (AI Act) art 6(1) and Annex I, applying to product-embedded high-risk AI from 2 August 2028 after Regulation (EU) 2026/1744](https://eur-lex.europa.eu/eli/reg/2024/1689/oj)
- [21 U.S.C. section 321(h) (device definition)](https://www.govinfo.gov/link/uscode/21/321)
- [21 U.S.C. section 360j(o) (software functions excluded from the device definition)](https://www.govinfo.gov/link/uscode/21/360j)

## Official form

[Official form](https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence-ai/manufacturing/artificial-intelligence-ai-and-medical-device-software-regulation)

## Full text and drafting notes

The full text and the drafting notes are not part of this public page. Signed-in firm accounts can read them at https://ailawframework.com/precedents/health-and-medical-law/ai-medical-device-regulatory-memo and through the signed-in MCP connector https://ailawframework.com/mcp/firm.

*Practice guidance for planning and review. Confirm current primary sources and the requirements of the actual matter. This is general information, not legal advice.*