Overview
While most TGA guidance applies across device classes, some guidance is specific to particular classes or risk levels. This page organises key guidance by device class to help you quickly find what's most relevant to your device. For the full guidance index, see All Guidance by Topic.
All Device Classes (General)
Guidance that applies regardless of classification:
| Guidance | Link |
|---|
| What is a medical device — TGA decision tool | TGA |
| Understanding medical device definitions | TGA |
| Complying with Essential Principles (all EPs) | TGA |
| Essential Principles Checklist template | TGA |
| Steps to supply — sponsors | TGA |
| Labelling requirements (EP 13) | TGA |
| Understanding post-market responsibilities | TGA |
| Reporting adverse events | TGA |
| PRAC — Recalls procedure | TGA |
Class I (Including Is and Im)
| Guidance | Link |
|---|
| Classification guidance (not IVDs) | TGA (PDF) |
| How to determine if product is correctly Class I | TGA |
| Declaration of Conformity for Class I | TGA |
| Passing preliminary assessment | TGA |
Key facts for Class I:
- Manufacturer self-certifies — no third-party QMS certification required (except Is/Im)
- Declaration of Conformity is the primary conformity assessment document
- ARTG application assessed at lower scrutiny level
- No mandatory audit (but risk-based audit possible)
Class IIa
| Guidance | Link |
|---|
| Classification guidance | TGA (PDF) |
| Obtaining manufacturer evidence | TGA |
| Comparable overseas regulators evidence guide | TGA |
| Application audit criteria | TGA |
Key facts for Class IIa:
- ISO 13485 QMS certification required
- Comparable overseas regulator evidence (CE certificate or equivalent) accepted
- Audit possible but not mandatory
- Declaration of Conformity required
Class IIb
| Guidance | Link |
|---|
| Classification guidance | TGA (PDF) |
| Comparable overseas regulators evidence guide | TGA |
| Implantable device guidance (for implantable IIb) | TGA |
| Patient implant cards | TGA |
| Annual reporting (implantable IIb) | TGA |
Key facts for Class IIb:
- Full QMS + product-specific certificate required
- Higher audit likelihood than Class IIa
- Annual reporting for implantable Class IIb devices
- Patient implant cards required for implantable devices
Class III
| Guidance | Link |
|---|
| Comparable overseas regulators evidence guide | TGA |
| Application audit criteria — mandatory audit applies | TGA |
| Clinical evidence guidance | TGA |
| Annual reporting — Class III | TGA |
| Patient implant cards | TGA |
| Reclassifying AIMDs | TGA |
Key facts for Class III:
- Full QMS + comprehensive product design assessment required
- Mandatory audit for applications supported by EU MDD or US 510(k)
- Annual reporting required (minimum 3 years post-inclusion)
- Patient implant cards mandatory
- Highest clinical evidence expectations
Active and Software Medical Devices
| Guidance | Link |
|---|
| Classifying active and software medical devices | TGA |
| Software and AI as medical devices — full hub | TGA |
| Cybersecurity for medical devices | TGA |
| Software exclusion guidance | TGA |
Key facts for Software/AI:
- Must be in ARTG from November 2024 (grace period ended)
- Classified based on severity of harm from incorrect output
- EP 12.1 applies — IEC 62304 software lifecycle standard
- Cybersecurity by design required
- Post-market monitoring of AI performance essential
IVD Class 1
| Guidance | Link |
|---|
| IVD overview and classification | TGA |
| Declaration of Conformity for Class 1 IVD | TGA |
| In-house IVDs (Class 1) | TGA |
IVD Class 2
| Guidance | Link |
|---|
| IVD overview and classification | TGA |
| Self-tests and point-of-care guidance | TGA |
| Blood glucose monitoring guidance | TGA |
IVD Class 3
| Guidance | Link |
|---|
| HIV self-tests guidance | TGA |
| Hepatitis B and C self-tests | TGA |
| Chlamydia, gonorrhoea and syphilis self-tests | TGA |
| Application audit criteria (mandatory for Class 3) | TGA |
IVD Class 4
| Guidance | Link |
|---|
| IVD overview and classification | TGA |
| In-house Class 4 IVD guidance | TGA |
| Application audit criteria (mandatory for Class 4) | TGA |
| TGA-NATA MoU for in-house IVDs | TGA |
Related Pages