This article deals with the public consultation for the cybersecurity labeling scheme for medical devices. Medical equipment is increasingly being linked to hospital and home networks in order to improve patient care. However, this connectivity expands the attack surface for hostile actors, possibly compromising patients’ personal information, clinical data, or treatment procedures, altering patient health results.

  1. The Ministry of Health, the Cyber Security Agency of Singapore, the Health Sciences Authority, and the Integrated Health Information Systems have collaborated to develop and roll out the Cybersecurity Labeling Scheme for Medical Devices (CLS-MD) at the Singapore International Cyber Week 2022.
  2. The CLS(MD) was created in collaboration with business leaders from the cybersecurity and medical technology industries.
  3. The CLS(MD) includes medical devices that fit any of the conditions mentioned below and are included in the First Schedule of the Health Product Act :
      • Handles personally identifiable information (PII) and clinical data and is capable of collecting, storing, processing, or transferring such data;
        • Connects to additional devices, software, and services – Possesses the capacity to communicate through a network of links using wired and/or wireless communication protocols.

      Things Under Consideration

      1. The CLS(MD) design includes four cybersecurity layers, each with 38 clauses. While registering any medical equipment in Singapore, HSA’s current cybersecurity criteria meet Level 1 requirements. The remaining clauses will be categorized as Level 2. For Levels 3 and 4, independent third-party testing is necessary.
      2. The independent third-party testing laboratories must be ISO 17025 certified and satisfy other standards outlined in the consultation paper.
      3. The CLS(MD) labels must be printed or applied to the packaging of equipment marketed to unlicensed medical or dental practitioners. The printing or attaching of the label is optional for professional-use only devices. The CLS(MD) label is valid for three years and can be revoked if certain conditions are not met. Before the expiry of the label, a new application is required to obtain a new label, which can be initiated three months before the expiry date.
      4. The Devices that are currently in use may also apply for the label. The procedure is determined by the CLS(MD) level being used.

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      Source : Health Sciences Authority, Singapore


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