The Health Sciences Authority (HSA) of Singapore has released a draft guidance document titled Best Practices Guide for Medical Device Cybersecurity for industry stakeholders’ consultation.
Key Highlights
Scope and Purpose:
- Intended for medical device manufacturers and healthcare providers.
- Establishes general cybersecurity principles, particularly advocating for a “Secure by Design” approach during the software development phase.
- Recommends best practices in the Total Product Life Cycle Framework, covering:Â
- Pre-market (Development Phase)
- Post-market (Support, Limited Support, and End of Support Phases)
Feedback Details:
- Consultation Period: 10 March 2025 – 12 May 2025
- Submission Requirements:Â
- Use the prescribed feedback template available in the official document.
Submit feedback to HSA via https://go.gov.sg/md-best-practices-for-consult
Additional Resources
This consultation provides an opportunity for medical device stakeholders to understand HSA’s current stance on medical device cybersecurity and contribute feedback to shape the final guidelines.
For further details, refer to the official draft guidance:
Best Practices Guide on Medical Device Cybersecurity (Draft for Consultation).
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