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January 19, 2026
Approximately 5 minutes
Medical Device Cybersecurity – Guidance from the TGA
Medical Device Cybersecurity – Guidance from the TGA
1. Importance of Cybersecurity for Medical Devices
Connected medical devices are increasingly vulnerable to cybersecurity threats that can compromise device functionality, patient data, or patient safety. The TGA requires manufacturers and sponsors to address cybersecurity risks as part of the essential principles for safety and performance under the Therapeutic Goods (Medical Devices) Regulations 2002. Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-device-cyber-security
Cyber threats may include unauthorized access, data breaches, ransomware, denial-of-service attacks, or manipulation of device settings. The TGA aligns its expectations with international standards such as IEC 81001-5-1 and IMDRF guidance on cybersecurity.
2. Risk Management Throughout the Device Lifecycle
Manufacturers must implement cybersecurity risk management from design through to end-of-life. This includes:
- Identifying cybersecurity risks during the design phase
- Implementing security controls to mitigate identified risks
- Validating and verifying security measures
- Monitoring for new threats post-market
- Having processes to respond to identified vulnerabilities Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-device-cyber-security
Risk management should be integrated into the overall quality management system and align with ISO 14971 principles, adapted for cybersecurity considerations.
3. Secure Design Principles
Key principles for secure design include:
- Secure by default configuration
- Least privilege access
- Secure authentication and authorization
- Data protection (encryption in transit and at rest where appropriate)
- Secure software development lifecycle
- Patch management capability Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-device-cyber-security
Manufacturers should document how these principles are applied and provide evidence during conformity assessment.
4. Vulnerability Management and Disclosure
Manufacturers must have processes to:
- Monitor for vulnerabilities (including from third-party components)
- Assess the impact of vulnerabilities on safety and performance
- Prioritize remediation based on risk
- Disclose vulnerabilities responsibly (e.g., via coordinated vulnerability disclosure programs)
- Provide timely patches or mitigations Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-device-cyber-security
Sponsors must notify the TGA of significant cybersecurity issues that may affect device safety or performance, particularly if they could lead to serious injury or death.
5. Post-Market Responsibilities
After market entry, ongoing responsibilities include:
- Monitoring cybersecurity intelligence sources
- Implementing field safety corrective actions when vulnerabilities are identified
- Updating risk management files
- Communicating security updates to users
- Maintaining capability to provide security patches throughout the expected lifetime Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-device-cyber-security
The TGA may take regulatory action if cybersecurity deficiencies pose unacceptable risks.
6. TGA Expectations and Conformity Assessment
During conformity assessment, the TGA expects evidence that cybersecurity has been appropriately addressed, particularly for connected or network-capable devices. Higher-risk devices undergo more rigorous scrutiny. Sponsors should refer to the TGA's cybersecurity guidance documents for detailed expectations.
7. Additional Resources
The TGA provides links to:
- Australian Cyber Security Centre (ACSC) guidance
- International Medical Device Regulators Forum (IMDRF) documents
- IEC 81001-5-1 standard
- FDA and other international cybersecurity resources Source: https://www.tga.gov.au/safety/safety-monitoring-and-information/medical-device-cyber-security
Manufacturers, sponsors, healthcare providers, and patients all play roles in maintaining cybersecurity. Early engagement with cybersecurity considerations helps ensure safe and effective use of connected medical devices in Australia.
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