The CYBER SECURITY AGENCY (CSA) of SINGAPORE encourages Medical Device (MD) Manufacturers to join the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] Sandbox, which started 20 October 2023 and will end in July 2024.
The CLS(MD) label indicates the level of cybersecurity provisions and features in the devices and allows users to make informed purchasing decisions. There are four levels of CLS(MD) labels:
| Cybersecurity Labels | Requirements |
|---|---|
| Level 1 | The product meets baseline cybersecurity requirements. |
| Level 2 | The product meets enhanced cybersecurity requirements. |
| Level 3 | The product meets enhanced cybersecurity requirements and must pass independent third-party software binary analysis and penetration testing. |
| Level 4 | The product meets enhanced cybersecurity requirements and must pass independent third-party software binary analysis and security evaluation. |
The Sandbox allows Manufacturers to test the Scheme by putting their devices through various assessment modes such as declaration of conformity against the baseline/enhanced security requirements, software binary analysis, penetration testing, and security evaluation. Hence, Manufacturers could provide their feedback on the requirements and improve the Scheme’s workflow.
Participating Manufacturers will be amongst the first to secure the CLS(MD) labels if their devices meet the respective scheme-level requirements and enhance their devices’ security in the process.
For more information, please refer to this document.
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