The Therapeutic Goods Administration (TGA) has released an updated version of its guidance document, Complying with the Essential Principles on the Safety and Performance of Medical Devices, revised on 20 November 2025.
This update provides medical device manufacturers, sponsors, and regulatory professionals with comprehensive direction on how to demonstrate compliance with the Essential Principles — the core safety and performance requirements that all medical devices must meet under the Therapeutic Goods (Medical Devices) Regulations 2002.
These Essential Principles are designed to ensure that every medical device supplied in Australia is of appropriate quality, performs as intended, and does not compromise the health or safety of patients, users, or others.
Understanding the Essential Principles
The Essential Principles are grouped into six general principles of safety and performance, and nine principles that apply to design and construction.
Manufacturers are required to apply these principles across all stages of a device’s lifecycle — from design and manufacture to labelling, supply, and ongoing post-market monitoring.
The updated guidance emphasises that compliance must be supported by objective evidence, which may include design documentation, test results, clinical evaluations, and conformity assessments carried out to recognised standards.
It also clarifies how manufacturers can use international standards (such as ISO 13485, ISO 14971, and ISO 10993) to demonstrate conformity.
Key Updates and Areas of Focus
1. Risk Management and Clinical Evaluation
Manufacturers must maintain an active, documented risk-management process consistent with ISO 14971.
Risks must be identified, analysed, and controlled throughout the entire product lifecycle.
The TGA now places greater emphasis on ensuring that manufacturers can demonstrate that the benefits of a device outweigh its residual risks, supported by clinical evaluation reports and post-market data.
2. Material Safety and Biocompatibility
Where devices come into contact with the human body, manufacturers are expected to assess material compatibility and potential toxicity.
The updated guidance references ISO 10993-1 and related standards as the preferred framework for biological evaluation. Evidence of testing or scientific justification must be maintained as part of the technical documentation.
3. Software and Cybersecurity
The TGA highlights the increasing use of software as a medical device (SaMD) and programmable electronic systems. Manufacturers must demonstrate robust software development, validation, and cybersecurity management to ensure continued safe performance. This includes managing vulnerabilities, maintaining secure data transfer, and preventing unauthorised access that could affect patient safety.
4. Electrical Safety and Energy-Emitting Devices
Devices powered by electricity, batteries, or other energy sources must comply with relevant IEC standards (such as IEC 60601 series).
The guidance clarifies that manufacturers must ensure protection against electrical shock, excessive heat, radiation exposure, or mechanical hazards during intended use and foreseeable misuse.
5. Information, Labelling, and Instructions for Use
Clear and accurate information must accompany every medical device, including labelling, packaging, and user instructions. The TGA now stresses the importance of transparency in device traceability, storage conditions, and expiry details, ensuring that users and healthcare professionals can safely operate and maintain the product.
Labels must also include identification codes, batch or serial numbers, and where relevant, Unique Device Identifiers (UDI).
6. Performance Verification and Quality Systems
Manufacturers must hold evidence demonstrating that devices consistently meet specifications and function as intended. This includes test data, design verification reports, and conformity assessments under a quality-management system aligned with ISO 13485.
The updated document reinforces that manufacturers are legally responsible for maintaining ongoing compliance, even after a device has entered the market.
7. Radiation and Active Devices
For devices that emit or use radiation — such as diagnostic imaging systems, lasers, or therapeutic energy sources — manufacturers must ensure that radiation doses are justified, minimised, and controlled.
The TGA recommends the application of relevant IEC and ISO safety standards to demonstrate conformity.
For full details, visit the TGA’s updated publication linked below.
This revised guidance represents the TGA’s ongoing effort to align Australia’s medical device regulations with global frameworks, particularly those of the European Union Medical Device Regulation (EU MDR 2017/745) and IMDRF (International Medical Device Regulators Forum) principles. It strengthens Australia’s focus on risk-based regulation, product traceability, and post-market vigilance, ensuring continued public confidence in medical devices used in healthcare settings.
Non-compliance with the Essential Principles may result in regulatory action, including suspension or cancellation of device inclusion in the Australian Register of Therapeutic Goods (ARTG), or enforcement under the Therapeutic Goods Act 1989.
Next Steps for Manufacturers
Manufacturers and sponsors are encouraged to:
Review the updated TGA guidance in full and assess its impact on existing and future products.
Ensure all technical documentation clearly demonstrates conformity to each applicable Essential Principle.
Update internal quality management systems, risk management files, and labelling practices to align with the revised expectations.
Maintain evidence of compliance ready for TGA audit or inspection.
Proactive compliance will help avoid regulatory delays and ensure continued access to the Australian market.
C-PRAV Group provides comprehensive product testing, certification, and regulatory consulting services to help medical device manufacturers meet TGA, CE, and global safety standards — from design evaluation to market approval.
