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SINGAPORE: CYBERSECURITY LABELLING SCHEME FOR MEDICAL DEVICES SANDBOX - DECEMBER/JANUARY 2024

SINGAPORE: CYBERSECURITY LABELLING SCHEME FOR MEDICAL DEVICES SANDBOX - DECEMBER/JANUARY 2024

  • 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).

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QT ANALYSIS: UPDATE IN THE CYBERSECURITY REGULATIONS OF MEDICAL DEVICES IN ASIA (CHINA, JAPAN, SINGAPORE) — AUGUST/SEPTEMBER 2023

QT ANALYSIS: UPDATE IN THE CYBERSECURITY REGULATIONS OF MEDICAL DEVICES IN ASIA (CHINA, JAPAN, SINGAPORE) — AUGUST/SEPTEMBER 2023

  • 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.

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China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration  (Revised Edition 2022)

China: Guidelines for Medical Device Cybersecurity, Medical Device Software, and AI Medical Device Registration (Revised Edition 2022)

  • 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.

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