Singapore’s Cybersecurity Agency Outlines New Labeling System for Medical Devices

Cybersecurity risks are now heightened by medical devices which are connected via the Internet and Intranet in hospitals and home networks. The Cybersecurity Agency Scheme for Medical Devices rates each device according to its cybersecurity risk. This scheme includes four designations of risk, levels 1-4, with level 1 being the lowest risk and levels above 1 being the higher risk. The different categories relate to the amount of testing the device has been through. Products with higher cybersecurity risk levels may need to meet stronger cybersecurity standards. Next month, there will be a meeting with government officials, medical associations, and industry to further outline the requirements needed for devices in the higher risk levels. Singapore’s Cybersecurity Agency was first started in 2015 and is connected to the Singapore Prime Minister’s office. Hopefully, this new labeling scheme will incentivize manufacturers to increase security early on during the development of their medical devices.

Written by: Ames Gross – President and Founder
Mr. Gross founded Pacific Bridge Medical 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.