All Guidance — By Topic
What is Guidance?
TGA guidance documents explain how the Therapeutic Goods Act 1989 and the MD Regulations apply in practice. They represent the TGA's current interpretation and expectations. Following TGA guidance is not legally mandatory — you may take a different approach if you can demonstrate compliance with the underlying legislative requirements. However, guidance represents the clearest path to demonstrating compliance, and deviating from it without justification risks audit findings or rejection.
The Australian Regulatory Guidelines for Medical Devices (ARGMD) is the TGA's primary index of all guidance relevant to medical devices. It is a living document, updated as new guidance is published.
Classification
| Guidance | Description | Link |
|---|---|---|
| Classification of medical devices (not IVDs) | How to apply Schedule 2 classification rules | TGA (PDF) |
| Classifying active and software medical devices | Software classification rules including November 2024 changes | TGA |
| IVD classification guidance | How to apply Schedule 2A IVD classification rules | TGA |
| How to determine if your product is a Class I device | Guidance for sponsors to confirm Class I classification | TGA |
| Reclassifying AIMDs to Class III | Transitional guidance for existing AIMD ARTG entries | TGA |
| Joint replacement device definitions | Regulatory amendments defining shoulder, hip, knee replacement devices | TGA |
Essential Principles
| Guidance | Description | Link |
|---|---|---|
| Complying with Essential Principles | Overview of how to demonstrate compliance with all 15 EPs | TGA |
| Essential Principles Checklist template | Downloadable checklist for technical file documentation | TGA |
| Cybersecurity for medical devices and IVDs | EP 12.1 cybersecurity requirements | TGA |
Conformity Assessment
| Guidance | Description | Link |
|---|---|---|
| Obtaining and maintaining regulatory evidence | Overview of conformity assessment pathways | TGA |
| Using assessments from comparable overseas regulators | Which overseas certificates are accepted and how to use them | TGA |
| Use of overseas regulator evidence (detailed table) | Full table of accepted evidence by device class (updated 2024) | TGA (PDF) |
| TGA conformity assessment certification | How to apply for a TGA Conformity Assessment Certificate | TGA |
| EU MDR transition guidance | Managing the EU MDR transition for Australian ARTG entries | TGA |
| MDSAP information | Medical Device Single Audit Program for Australian applications | TGA |
| Declaration of Conformity for Class I and Class 1 IVD | DoC requirements for self-certification classes | TGA |
ARTG Inclusion
| Guidance | Description | Link |
|---|---|---|
| Steps to supply for sponsors | Step-by-step ARTG inclusion guide for sponsors | TGA |
| Steps to supply for manufacturers | Step-by-step guide for manufacturers | TGA |
| Passing preliminary assessment | What the TGA checks at preliminary assessment | TGA |
| Application audit selection criteria | How the TGA selects applications for audit (updated 2024) | TGA |
| Varying an ARTG entry | When and how to submit a variation | TGA |
| Significant changes guidance | How to identify and notify the TGA of significant changes | TGA |
| Fees and charges summary | Current ARTG application and annual fees | TGA |
| Processing timeframes | Expected processing times for ARTG applications | TGA |
Clinical Evidence
| Guidance | Description | Link |
|---|---|---|
| Clinical evidence for medical devices | Overview of EP 14 clinical evidence requirements | TGA |
| Clinical trials for medical devices | CTN/CTA pathways for device clinical trials | TGA |
| IMDRF clinical evaluation guidance | International framework for clinical evaluation (referenced by TGA) | IMDRF |
Specific Device Types
| Guidance | Description | Link |
|---|---|---|
| Software and AI as medical devices | SaMD regulatory framework, classification, exemptions | TGA |
| In-house IVD guidance | Regulatory requirements for in-house IVD medical devices | TGA |
| Self-tests and point-of-care IVDs | Requirements for consumer and near-patient IVDs | TGA |
| Custom-made devices | Regulatory framework for custom-made medical devices | TGA |
| Personalised medical devices | Guidance for patient-matched and personalised devices | TGA |
| Systems and procedure packs | Requirements for SOPPs and charities | TGA |
| Single-use devices and reprocessing | Regulatory requirements for reprocessing single-use devices | TGA |
| Export-only devices | Requirements for devices exported from Australia | TGA |
| Devices incorporating a medicine | Classification and requirements for combination products | TGA |
| Animal, microbial, recombinant origin (from July 2024) | New requirements from 1 July 2024 | TGA |
| Understanding medical device definitions | Definition of medical device, SOPPs, accessories | TGA |
| 3D printing / additive manufacturing | Requirements for 3D-printed medical devices | TGA |
| First aid kits | Regulatory requirements for first aid kits as SOPPs | TGA |
Post-Market
| Guidance | Description | Link |
|---|---|---|
| Understanding post-market responsibilities | Overview of all post-market obligations | TGA |
| Reporting adverse events for medical devices | How to report to IRIS — sponsor guidance | TGA |
| Reporting by healthcare facilities | Guidance for hospitals under the new mandatory reporting framework | TGA |
| PRAC — Procedure for Recalls, Product Alerts and Corrections | The new recall procedure (March 2025) | TGA |
Labelling and Advertising
| Guidance | Description | Link |
|---|---|---|
| Medical device labelling requirements | EP 13 labelling obligations | TGA |
| Patient information materials for implantable devices | Patient implant card requirements | TGA |
| UDI — Unique Device Identification | UDI requirements and database | TGA |
| Applying the Advertising Code | Overview of Advertising Code requirements | TGA |
| Advertising to health professionals | How to advertise exclusively to health professionals | TGA |
| Social media advertising guidance | Requirements for advertising therapeutic goods on social media | TGA |
| Restricted and prohibited representations | What claims require TGA approval or are prohibited | TGA |
| Off-label use and advertising | Rules for advertising off-label uses | TGA |
Special Access and Unapproved Devices
| Guidance | Description | Link |
|---|---|---|
| Special Access Scheme — medical devices | SAS pathways for unapproved devices | TGA |
| Authorised prescribers — medical devices | Health practitioner authorisation pathways | TGA |