Announced at the Singapore International Cyber Week 2023, the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] Sandbox is open for application starting 20 October 2023, 10 am.

Under the sandbox, Manufacturers are invited to participate in the sandbox to test out and give feedback on the requirements and application processes by putting their medical devices through the different assessments, such as the declaration of conformity against the baseline/enhanced security requirements, software binary analysis, penetration testing, and security evaluation. Medical device manufacturers to have a first-mover advantage in enhancing the security of their products. 

The Sandbox will run for nine months and the feedback and learnings from the sandbox will be used to refine the requirements and operational workflow of the scheme where necessary.

Applications for the Sandbox will be open for all four levels of rating under the CLS(MD). 

Cybersecurity Levels

 

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

Level Requirement 
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

 

Application

Applications for the Sandbox can be made at https://www.gobusiness.gov.sg. Kindly note that the submission of the application via GoBusiness Licensing Portal does not imply the acceptance of the application under the Sandbox by CSA. Upon submission, the application will be reviewed by CSA prior to its acceptance under the Sandbox. CSA will formally confirm the acceptance of the CLS(MD) Sandbox application via email. Applicants may refer to the “GoBusiness Licensing Portal Application Guide for instructions on application via GoBusiness Licensing Portal:

The list of approved CLS(MD) testing laboratories can be found at https://www.csa.gov.sg/cls-md-labs

 

For further enquiries, please kindly reach out to cls_md@csa.gov.sg