On February 17, Singapore’s Health Sciences Authority (HSA) published a number of revised guidance and technical reference documents.
Version and cybersecurity requirements for software registration
The following documents pertain to software registration:
- 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
Each of these documents has been updated to specify that in cases of software registration, the Registrant is required to provide the actual version to be supplied in Singapore (“the software version number that represents various software changes/iteration”). Additionally, the CSDT/ToC design verification and validation documents should include “cybersecurity control measures for connected medical devices.”
Notification changes for medical devices and IVD analyzers
The HSA also updated the Guidance on Change Notification for Registered Medical Devices (GN-21-R4.7) and the Guidance Document for IVD Analyzers (GN-34-R1.3). GN-21-R4.7 now provides details about bundled notification changes, and various revisions were made to the flow charts and documentary requirements tables. GN-34-R1.3 was updated to provide further explanation for the SMDR listing options for closed-system IVD analyzers, as well as the relevant change notification applications. This revision also includes updated process flowcharts and modified definitions.