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Singapore Releases New Guidance of Medical Device Software
Singapore’s HSA has updated their requirements for software application submissions, requiring the specific version number and iteration of the software to be sold in Singapore. They also updated the design verification and validation sections of Common Submission Dossier Template (CSDT) to include “cybersecurity control measures for connected medical devices.” The added measure comes as more competent authorities look to increase security for crucial medical devices and systems following a global uptick in recalls due to software malfunctions. An analysis of US FDA data conducted by Ronquillo and Zuckerman in 2017 showed that there were 627 software related recalls between 2011 and 2015 and according to Stericycle’s Q3 2019 Recall Index, software had been the leading cause of recalls for the 14 prior quarters in a row.
HSA Documents pertaining to Software Requirements:
- TR-01-R1: Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT
- TR-02-R1: Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices Using the ASEAN CSDT
- E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS
- E-Submission Guide for In Vitro Diagnostic Medical Devices for ASEAN CSDT and IMDRF Toc based Submissions in MEDICS
The HSA also released revisions to the Guidance Documents, GN-21: “Guidance on Change Notification for Registered Medical Devices” and GN-34: “Guidance Document for IVD Analyzers.” Changes to GN-21 include allowing notification changes to be bundled together, the timelines for notifying the HSA and flowcharts for assisting Registrants determine changes related to sterilization and IVD software. GN-34 revisions also provides updates to flowcharts, definitions and the change notification process, along with clarifying SMDR listing options for closed-system IVD analyzers.