The Hong Kong Medical Device Administrative Control System (MDACS) has published a new technical reference document (TR-007) related to software medical devices (SaMD and SiMD) on December 29, 2023.
Technical Reference TR-007 covers SiMD and SaMD risk management requirements and basic cybersecurity requirements.
The software medical device technical documentation requirements for MDACS application are as follows:
1. QMS
2. Essential Principle for safety and performance of medical devices
3. Labelling requirements
4. Risk management
5. Clinical evaluation
6. Marketing approval(s) from jurisdictions recognised under MDACS (USA, Canada, Europe, Japan, Australia, China, Korea)
7. Software verification and validation
8. Software versioning and its traceability
9. Cybersecurity of medical devices
Cybersecurity management is required as risks such as patient data leakage may occur while transmitting data through a device connected to the network. For more information on the guidelines for cybersecurity management requirements, please refer to section 5.5.3 of the attached document (TR-007).
Additionally, we also provide guidance on cybersecurity-related standards.
- ISO 27032 Cybersecurity – Guidelines for Internet Security
- ISO/IEC 27001 Information security, cybersecurity and privacy protection
If you have any questions about medical device,
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info@jnmglobal.net
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