Australia TGA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: Therapeutic Goods Administration (TGA), under the Department of Health and Aged Care
Key Legislation:
- Therapeutic Goods Act 1989
- Therapeutic Goods (Medical Devices) Regulations 2002
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
Classification: Risk-based, 4 tiers for non-IVD devices:
- Class I (low risk) | Class IIa (low-medium risk) | Class IIb (medium-high risk) | Class III (high risk)
- IVD devices: Class 1, 2, 3, 4
- Classification rules in Schedule 2 (non-IVDs) and Schedule 2A (IVDs) of the Regulations
Registration Pathway:
- Determine device classification per Schedule 2/2A rules
- Demonstrate compliance with Essential Principles (safety & performance requirements)
- Complete conformity assessment (self-assessment for Class I; CAB assessment for higher classes)
- Appoint an Australian Sponsor (mandatory for foreign manufacturers)
- Submit application for inclusion in the Australian Register of Therapeutic Goods (ARTG)
Key Requirements:
- Inclusion in ARTG mandatory before legal supply in Australia
- Australian Sponsor required for all devices (local entity responsible for the device)
- Essential Principles compliance: 15 principles covering safety, performance, design, and construction
- Quality Management System evidence (ISO 13485 for higher-risk devices)
- Post-market obligations: adverse event reporting, recalls, periodic reviews
Current Key Guidance:
- ARGMD - Overview
- Essential Principles Checklist
- Classification Guidance (non-IVD)
- Software-based Medical Devices
Latest Updates
No recent updates available. Please check back later.