Singapore’s HSA Proposes New Device Labeling Requirements for Cybersecurity

By March 3, 2023, Singapore’s HSA has requested industry comments on proposed medical device labeling for cybersecurity. The draft cybersecurity labeling scheme for medical devices (CLSMD) was initiated in late 2022 by the HSA, MOH, and Integrated Health Information Systems. Today, more medical devices are coupled between home and hospital networks, and security must be maintained.

With 38 clauses, the proposed structure for CLS includes 4 cybersecurity levels. Level 1 is already included in Singapore’s existing cybersecurity law. Other devices with additional cybersecurity issues fall into level 2. For levels 3 and 4, third-party testing is needed. CLS labels will be good for 3 years but need to be renewed 3 months before the original label expires. If specific conditions do not meet these new proposed requirements, labels can become null and void.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.