Singapore HSA Singapore Launches New Digital Health Webpage

HSA launched this webpage in December 2020 as a one-stop portal to encourage innovation in the area of digital health by providing greater clarity on the regulatory controls and guidelines on the digital health products that are regulated as medical devices.

It contains the following sections:
-What is Digital Health
-Supporting Digital Health Product Innovation
1. Regulatory Guidelines for Telehealth Products
2. Immediate Registration Pathway for Standalone Software and Mobile Applications
3. Device Development Consultation Scheme
4. Regulatory Guidelines for Software Medical Devices
-Identifying Digital Health Products that are Medical Devices
-Overview of Regulatory Controls
(i) Product Registration
(ii) Dealer’s licensing
(iii) Post-market requirements
(iv) Any other applicable Regulatory Requirements and Guidelines

More information can be accessed here :

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