Consultation on Regulatory Guidelines for Software Medical Devices- A Lifecycle Approach
[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 Approach1313 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.
Guidance Feedback Form12 KB
Healthcare professional, Industry member, Medical devices
Published:
Regulatory Updates