Creator: SOMKID THONGDEE
Another question our team recently received was: "What cybersecurity-related documents should I prepare to ensure my TGA submission goes smoothly?"
To ensure a smooth Therapeutic Goods Administration (TGA) submission for medical devices with cybersecurity components, you should prepare and include the following cybersecurity-related documents:
1. Cybersecurity Risk Management Plan
- Risk Assessment: Detailed analysis identifying potential threats, vulnerabilities, and impacts.
- Mitigation Strategies: Plans and actions to address identified risks.
2. Cybersecurity Design and Development Documentation
- Security Requirements: Specifications for cybersecurity features and functions in the device.
- Architecture and Design: Detailed design documents showing how cybersecurity is integrated into the device.
- Software Development Lifecycle: Evidence that the development follows recognized standards (e.g., ISO/IEC 62304).
3. Testing and Validation Reports
- Vulnerability Analysis: Results from vulnerability scans and penetration testing.
- Verification and Validation: Documentation demonstrating that the device meets cybersecurity requirements.
4. Incident Response Plan
- Response Procedures: Detailed procedures for responding to cybersecurity incidents.
- Communication Plan: Strategies for informing users, stakeholders, and regulatory bodies about incidents.
5. Post-Market Surveillance Plan
- Monitoring Strategy: Ongoing monitoring for new vulnerabilities and threats.
- Update and Patch Management: Procedures for providing timely updates and patches.
6. Supply Chain Security Management
- Supplier Evaluation: Assessment and selection of suppliers based on their cybersecurity practices.
- Supply Chain Risk Management: Procedures to ensure security throughout the supply chain.
7. User Training and Awareness Documentation
- User Guidance: Instructions for users on maintaining cybersecurity (e.g., software updates, safe usage practices).
- Training Materials: Resources provided to users and staff for cybersecurity awareness and best practices.
8. Compliance and Regulatory Documentation
- Standards Compliance: Evidence of compliance with relevant standards (e.g., ISO/IEC 27001, ISO/IEC 14971).
- Regulatory Filings: Any previously submitted documents to other regulatory bodies demonstrating cybersecurity compliance.
9. Cybersecurity Labelling and Instructions for Use
- Labelling Requirements: Clear and accurate labelling regarding the device's cybersecurity features.
- Instructions for Use: Detailed instructions on cybersecurity aspects, including updates and maintenance.
10. Document Control and Quality Management
- Document Control Procedures: Ensuring all documents are up-to-date and accurately maintained.
- Quality Management System (QMS): Integration of cybersecurity processes within the overall QMS.
Preparing these documents thoroughly and ensuring they align with TGA's requirements will facilitate a smoother submission process. If you need more detailed information on any specific document or further assistance, feel free to ask our team!
