TGA Updates Guidance on Essential Principles for Medical Device Safety and Performance

The Australian Therapeutic Goods Administration (TGA) has released an updated consolidated version of its guidance “Complying with the Essential Principles on the safety and performance of medical devices”. This document outlines the legislative requirements that all medical device manufacturers must meet before placing devices on the Australian market, as defined under the Therapeutic Goods (Medical Devices) Regulations 2002.

The Essential Principles form the foundation of Australia’s regulatory framework, covering critical areas such as device design and construction, long-term safety, infection control, risk management, labelling, clinical evidence, and specific rules for IVDs. The updated guidance consolidates legislative requirements and provides enhanced explanations aimed at helping manufacturers demonstrate compliance throughout the device lifecycle.

For manufacturers, this update reinforces the need to maintain robust technical documentation, comprehensive risk-management files, and evidence demonstrating conformity with the state of the art. The TGA also emphasises accountability for demonstrating that safety and performance claims are supported by scientific and clinical evidence, as well as ensuring traceability, usability, and post-market monitoring across all device classes.

Manufacturers seeking market access in Australia should carefully review the new consolidated guidance and ensure their processes, documentation, and evidence meet the strengthened expectations. This update provides greater clarity but also reinforces compliance obligations, particularly in relation to long-term safety, clinical evidence, and risk management.

The full guidance document is available for download below.