In an effort to enhance cybersecurity for medical devices, Singapore’s Cyber Security Agency (CSA), Ministry of Health (MOH), Health Sciences Authority (HSA), and Synapxe have introduced the Cybersecurity Labelling Scheme for Medical Devices (CLS-MD). This voluntary scheme classifies medical devices by their cybersecurity safeguards, empowering healthcare providers and consumers to make more informed purchasing decisions regarding device security.
Scope and Levels of the CLS-MD
As medical devices increasingly connect to networks, they face heightened cybersecurity risks. To counter these risks, Singapore’s CLS-MD encourages manufacturers to adopt a “security-by-design” approach, aiming to prevent data breaches and ensure secure device operation.
The CLS-MD applies to devices that handle personal or clinical data or connect to external systems, as defined under the Singapore Health Products Act. There are four levels in the scheme, each indicating progressively rigorous cybersecurity requirements:
- Level 1: Meets baseline cybersecurity requirements.
- Level 2: Enhances basic protections.
- Level 3: Requires third-party software binary analysis and penetration testing.
- Level 4: Includes comprehensive third-party security evaluation.
CLS-MD’s Sandbox Phase and Industry Feedback
The CLS-MD was refined through a sandbox phase that ran from October 2023 to July 2024, which allowed 19 manufacturers to test and provide feedback. The phase saw 47 applications, leading to updates in the assessment process, clearer application templates, and streamlined guidelines to meet security standards.
Click here to read the official announcement.
Quick Country Facts
Singapore
Certification Body: Infocomm Media Development Authority (IMDA)
Certification Type: Mandatory
License Validity: 60 months
Application Language: English
Legal License Holder: Available with Access Manager
In-Country Testing Requirement: Available with Access Manager
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