Cybersecurity Labelling Scheme for Medical Devices (Level 2)

Apply for Cybersecurity Labelling Scheme for Medical Devices (Level 2)

Cyber Security Agency (CSA)

Application Details

The Cybersecurity Labelling Scheme for Medical Devices (CLS(MD)) is a joint initiative by the Cyber Security Agency of Singapore (CSA), Ministry of Health (MOH), Health Sciences Authority (HSA), and Synapxe as part of efforts to improve medical device cybersecurity.

Under the voluntary CLS(MD), medical devices are rated according to 4 levels of cybersecurity provisions and assessments. The cybersecurity label for medical devices would provide an indication of the level of security in medical devices. The scheme seeks to incentivise manufacturers to adopt a security-by-design approach, and to enable consumers and healthcare providers to make more informed decisions about the use of such devices.

The scope of the CLS(MD) applies to medical devices as described in the First Schedule of the Health Product Act (Cap122D, 2008 Rev Ed) and have any of the following characteristics:

Handles personal identifiable information (PII) and clinical data and has the ability to collect, store, process, or transfer such data;
Connects to other devices, systems, and services - Has the ability to communicate using wired and / or wireless communication protocols through a network of connections.

For more information, please visit https://www.csa.gov.sg/cls-md or kindly contact cls_md@csa.gov.sg