RAPath Australia
Australian Medical Device Regulatory Reference
Content is AI-assisted and intended as a navigation aid only — not legal or regulatory advice, and not affiliated with the TGA or the Australian Government. Always verify against official TGA and legislation.gov.au sources before making any regulatory decision.
RAPath AU is a plain English reference for Australian medical device regulation. It is designed to help regulatory affairs professionals, sponsors, manufacturers, importers, and consultants quickly find and understand TGA requirements.
This site does not replace official TGA sources. Every page links back to the authoritative legislative text or official TGA guidance. RAPath AU is a structured, searchable navigation tool designed to help you quickly locate what you need, then directs you to the official source for verification and final decision-making.
Regulatory Pathway Map
Click a phase to expand — each card links to the relevant section of this guide.
Who this site is for
Regulatory affairs professionals and consultants — a well-structured reference for requirements you navigate daily, with every claim linked to its legislative source.
Sponsors — understand your obligations from ARTG application through to ongoing post-market compliance.
Manufacturers (Australian and overseas) — understand what the Australian regulatory framework requires of you, and how it relates to frameworks you may already know (EU MDR, FDA, Health Canada).
Importers and distributors — understand when importing makes you the sponsor, and what that means.
Anyone new to Australian medical device regulation — start with Start Here for a guided introduction to the framework.
How to use this site
The site is organized around the regulatory lifecycle of a medical device, from initial classification through post-market surveillance:
| Section | What it covers |
|---|---|
| Start Here | Definitions, regulatory framework, key roles, device lifecycle, glossary |
| Pre-Market | Classification, Essential Principles, conformity assessment, ARTG inclusion, clinical evidence, special device types |
| Post-Market | Adverse event reporting, recalls and PRAC, post-market surveillance, ARTG maintenance, labelling and advertising |
| Legislation | The Therapeutic Goods Act, MD Regulations, related instruments, how to read legislation |
| Guidance | Full index of TGA guidance documents by topic and device class, forms and application links |
| What's New | Recent regulatory changes, open consultations, upcoming changes, reforms tracker |
| Unapproved Device Access | SAS, authorised prescribers, clinical trials, personal importation |
| Other Therapeutic Goods | Disinfectants and sterilants, tampons and menstrual cups, unapproved medicines |
Where to start
If you are new to Australian medical device regulation: → What is a Medical Device?
If you need to classify a device: → How Classification Works
If you are preparing an ARTG application: → ARTG Inclusion — Overview
If you need to report an adverse event: → Adverse Event Reporting
If a recall may be required: → When a Recall is Required
Questions or corrections
If you spot an error or have a question, visit GitHub Discussions.
Consider adding a note in the Introduction section: 'This reference reflects TGA requirements as of [DATE]. Recent regulatory changes include [specific updates]. See What's New section for the latest TGA reforms and implementation timelines.'