🇦🇺Australia Medical Device Regulations

Medical Devices Containing Medicinal/Animal Origin Substances

Guidance on new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances. Effective July 2024.

Australian Regulatory Guidelines for Medical Devices (ARGMD)

Comprehensive index of TGA guidance for medical devices including Essential Principles, conformity assessment, classification, and post-market requirements. Updated December 2024.

Standards, Guidelines & Publications for Medical Devices and IVDs

Comprehensive collection of TGA standards, guidelines, and publications for medical devices and IVDs. Essential resource for regulatory compliance.

Medical Devices Reforms - Regulatory Changes

Overview of ongoing medical device regulatory reforms in Australia. Includes MMDR implementation, new approval pathways, and classification changes.

Regulatory Basics for Health Practitioners (PDF)

TGA guidance for health practitioners on medical device regulation. Explains regulatory requirements for manufacturing, supplying, and using medical devices.

Regulatory Changes for Software-Based Medical Devices (PDF)

TGA guidance on regulatory requirements for software-based medical devices including SaMD. Covers classification changes and transitional arrangements ending November 2024.

Understanding Processing Timeframes for Medical Device Applications

TGA guidance on target timeframes for medical device application processing. Reflects MMDR recommendation 21 for international benchmark alignment.

Therapeutic Goods (Medical Devices) Regulations 2002 - TGA Summary

TGA summary of the Medical Devices Regulations 2002 including classification, essential principles, conformity assessment, and ARTG inclusion requirements.

Therapeutic Goods (Medical Devices) Regulations 2002 - Federal Register

Full legal text of the Therapeutic Goods (Medical Devices) Regulations 2002 from Federal Register of Legislation. Official consolidated version.

Therapeutic Goods Act 1989 - Full Legislation Text

Primary legislation governing therapeutic goods including medical devices in Australia. Establishes TGA authority, ARTG requirements, and regulatory framework.