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Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD)

As ‘smart’ medical devices are commonly used in the health settings with increased connectivity to the cyber world, it’s inevitable to have an increased potential risks of cyber-attacks as well. Thus, at the Singapore International Cyber Week 2022, the Ministry of Health (MOH), Cyber Security Agency of Singapore (CSA), Health Sciences Authority (HSA), and the Integrated Health Information Systems (IHiS) has collaborated to develop and roll out the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)]

The scope of CLS (there are currently 4 cybersecurity levels) are part of First Schedule of the Health Product Act (Cap122D, 2008 Rev Ed), which involved personal identifiable information (PII) as well as communications between medical devices using wired or wireless protocols. 

This CLS shall also be applied to currently used medical devices. It is mandatory for devices used by non-medical/dental qualified personnel while it is optional if they are used by medical/dental professionals. Validity of this label shall be 3 years. 

The consultation window for comments and feedback will be opened starting from 25 January 2023 to 03 March 2023. Further information on the proposed framework, comments, and feedbacks can be accessed here.

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