Regulatory Updates
Consultation on Regulatory Guidelines for Software Medical Devices- A Lifecycle Approach
Audiences
Healthcare professional
Industry member
Product type
Medical devices
24 December 2019
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[Updated on 24 December 2019]
The Medical Devices Branch (MDB) has released a draft document Regulatory Guidelines for Software Medical Devices – A lifecycle approach for stakeholders’ consultation. This document intends to provide clarity on the regulatory requirements for software medical devices during its entire lifecycle. We would like to invite our stakeholders to provide feedback on this document:
Regulatory Guidelines for Software Medical Devices- A Lifecycle Approach [PDF, 1314 KB]
The Consultation period for this document is from 26 December 2019 to 31 January 2020. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 31 January 2020. Please indicate "Regulatory Guidelines for Software Medical Devices Feedback" in the email subject header.