Regulatory Updates
Conclusion to the Consultation on the Regulatory Guidelines for Telehealth
Audiences
Healthcare professional
Industry member
Product type
Medical devices
31 August 2017
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[Updated on 31 August 2017]
The Medical Devices Branch (MDB) of Health Sciences Authority (HSA) would like to thank our stakeholders for your feedback on the proposed regulatory guidelines for Telehealth Products. HSA has incorporated relevant suggestions into the finalised document. We have attempted to clarify other common queries raised during the consultation in the FAQ document.
The guidelines are intended to provide clarity on the types of Telehealth Products that are regulated as medical devices, as well as its current regulatory approach and requirements for such Telehealth Products. The guidelines reflect HSA's current policy stance and practice, and should not be misconstrued as a new regulatory control on Telehealth Products. Do note that the new Immediate Registration Route for Standalone Mobile Applications will be available at a later date when the legislations (Medical device Regulations) are updated as necessary.
The finalised guidelines and FAQ documents are attached below:
REGULATORY GUIDELINES FOR TELEHEALTH PRODUCTS [pdf]
FAQ-TELEHEALTH PRODUCTS GUIDELINES [pdf]