Launch of Cybersecurity Labelling Scheme for Medical Devices

As cybersecurity risks continue to proliferate, Singapore has turned its attention to the cybersecurity of medical devices. Currently, medical devices must be registered with the Health Sciences Authority (“HSA“) and meet regulatory requirements, including cybersecurity requirements, before they can be imported, distributed and sold locally. However, medical devices are becoming more digitally connected to hospital and home networks, raising the need to enhance their cybersecurity safeguards.

To address this, the Cyber Security Agency of Singapore, the Ministry of Health, HSA and Synapxe have jointly developed the Cybersecurity Labelling Scheme for Medical Devices (“CLS(MD)“), a voluntary scheme where medical devices are rated according to their levels of cybersecurity provisions.

This first-in-the-world multi-levelled CLS(MD) seeks to improve the cybersecurity of medical devices by encouraging manufacturers to adopt a security-by-design approach. The labelling scheme also allows healthcare providers and consumers to make more informed decisions from a security perspective about the medical devices they purchase and use.

The CLS(MD) applies to medical devices as defined in the First Schedule of the Singapore Health Products Act, and which handle personal identifiable information and clinical data, or are able to connect to other devices, systems and services. The scheme comprises four levels to reflect the testing and assessment that the product has undergone:

  • 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 will be required to pass independent third-party software binary analysis and penetration testing.
  • Level 4: The product meets enhanced cybersecurity requirements and will be required to pass independent third-party software binary analysis and security evaluation.

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