• 2025-04-24 08:42:19

HSA's Medical Devices Cluster has released a draft on Best Practices Guide for Medical Device Cybersecurity for stakeholder consultation. The document provides recommendations on cybersecurity best practices for medical devices, focusing on both pre-market and post-market stages of the device's Total Product Lifecycle (TPLC).

This document is targeted for Medical Device Manufacturers and Healthcare providers, and currently available as a draft for consultation. Which opens from 10 March 2025 to 12 May 2025. The feedback can be submitted by filling out the provided template and upload to the established link.

• 2024-12-16 08:32:04

Following the Industry Consultation held from 25 January to 10 March 2023 and Sandbox Phase conducted from October 2023 to July 2024, the CSA, in collaboration with MoH, HSA, and Synapse launches the Cybersecurity Labelling Scheme for Medical Device [CLS(MD)] for public applications along with a set of publications as guidelines for the applicants. The program opens for voluntary enrollment on 16 October 2024 as part of Singapore’s effort to enhance cybersecurity awareness.

Manufacturers who wish to pursue one of the 4 cybersecurity levels should apply to Cybersecurity Certification Centre (CCC) through GoBusiness Licensing Portal https://www.gobusiness.gov.sg while inquiries can be sent to email: cls_md@csa.gov.sg.

• 2024-06-20 05:41:18

The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.

• 2024-01-26 04:02:59

HSA is issuing Safety Alerts for all medical devices employing 5G modem due to the arising 5Ghoul Cybersecurity Vulnerabilities.

• 2023-12-26 02:27:39

Following the industrial consultation earlier this year, Cyber Security Agency (CSA) of Singapore is launching Sandbox as a voluntary trial program for Cybersecurity Labelling Scheme for Medical Devices (CLS(MD)). This program started on 20th October 2023 and will be held for 9 months. CSA is inviting medical device manufacturers to participate in Sandbox to have a first-mover advantage in enhancing the security of their products.

The Sandbox allows all parties involved to test out and give feedback on the requirements and application process for the CLS(MD) ahead of the scheme’s launch. Along with the launch of Sandbox program, CSA also published intensive set of regulations related to the requirements and implementation of CLS(MD).

• 2023-09-27 07:05:52

The Japanese MHLW has issued Q&A on Software Cybersecurity that was newly added to the Essential Principle

• 2023-08-23 06:27:14

Qualtech highlights the critical role of cybersecurity in safeguarding medical devices and patient well-being, emphasizing the potential risks posed by connectivity and the need for stringent measures to counteract vulnerabilities. We emphasize the collaborative efforts required among medical device stakeholders to establish and maintain robust security standards. This QT analysis revisits a previous cybersecurity article with a focus on recent developments in Japan, China, and Singapore.

• 2023-05-24 07:21:35

The Japanese MHLW has issued a complimentary notice to explain further about cybersecurity of the Essential Principles Requirements.

• 2023-02-23 01:28:49

A consultation window for framework and implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] was announced to be open for the public from January 23 to March 3, 2023.

• 2022-04-27 11:16:17

NMPA has released a series of updated guidelines, which aim to guide registration applicants to prepare for medical device software and AI medical device registration in China. The 3 new guidelines regulate the technical reviewing requirements of medical device software and AI medical devices, while also elaborating on standardizing the cyber-security for medical devices.