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CLS(MD) Registration

Cybersecurity Labelling Scheme for Medical Devices application details.

Last updated 5 February 2025

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Application for CLS(MD)
Engagement of Approved Test Laboratories

Application for CLS(MD)

Cybersecurity Levels

The CLS(MD) comprises four levels of rating, and applications are open for all four levels.

Table of Cybersecurity Levels (1-4) for medical devices, showing criteria met via developer or third-party testing.

The CLS(MD) comprises four levels of rating, corresponding to the number of crosses on the label.

CLS(MD) levels and its requirements

Level

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 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.

Engagement of Approved Test Laboratories

This is applicable for all applications submitted after the launch of CLS(MD) on 16 October 2024.

Before applying through GoBusiness, applicants must engage an Approved Testing Laboratory to review their Declaration of Conformity and related supporting evidence comprehensively. This requirement applies to all levels of the scheme.

     a. Engagement of an Approved Testing Laboratory is mandatory for all levels of the Cybersecurity Labelling Scheme for Medical Devices (CLS(MD)).

     b. Prior to application submission, the Approved Testing Laboratory shall conduct a review of the Declaration of Conformity and supporting evidence. The manufacturer shall address all observations and comments arising from this review.

     c. Applications shall comprise the following documentation:
         • The Manufacturer’s Declaration of Conformity and Supporting Evidence
         • The Approved Testing Laboratory’s Assessment of the aforementioned documents.

The application fees are available at CLS(MD) Fee Schedule [PDF, 171 KB]. Please note that there will be an additional cost incurred by the Approved Testing Laboratory for reviewing the Declaration of Conformity and supporting evidence.

More information on the CLS(MD) requirements and application process are available within Publications.

For detailed instructions on how to apply through the GoBusiness, please refer to: