RAPath AU
Australian Medical Device Regulatory Reference
RAPath AU is a plain English reference for Australian medical device regulation. It is designed for regulatory affairs professionals, sponsors, manufacturers, importers, and consultants who need to find and understand TGA requirements quickly.
This site does not replace official TGA sources. Every page links back to the authoritative legislative text or official TGA guidance. Think of RAPath AU as a structured, searchable index that helps you find what you need — then points you to the official source to verify it.
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 structured around the regulatory lifecycle of a medical device:
| 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 |
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, corrections and discussions
RAPath AU is a community reference. If you find an error, have a regulatory question, or want to discuss a recent TGA change, use GitHub Discussions:
Regulatory affairs professionals who flag inaccuracies are the most valuable contributors to this project.
Disclaimer
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official TGA and legislation.gov.au sources before making regulatory decisions. This site is not affiliated with the TGA or the Australian Government. Not legal or regulatory advice.