The Revision 2 provides updated regulatory guidance for in vitro diagnostic (IVD) analysers and their associated accessories. It focuses on risk classification, grouping, SMDR (Singapore Medical Device Register) listing options, and change notification requirements.
Scope
Summary of the updated GN-34 Guidance Document for IVD Analysers (Revision 2) issued by the Health Sciences Authority (HSA), Singapore, outlining revisions to risk classification, SMDR listing options, and change notification procedures.
Key Highlights
- Risk Classification Enhancements
Revision 2 introduces clearer flowcharts and examples for classifying IVD analysers, especially distinguishing standalone vs closed-system analysers. It aligns more explicitly with GN-14 rules and emphasizes the highest risk class of compatible reagents for closed systems. - SMDR Listing Option 2 – SPLIT Listings for New Closed System Analysers
Option 2 refers to SPLIT IVD Analyser Device Listing from compatible IVD reagents. This option mandates compatible reagent(s) to be listed independently as reagent-only listings, while the analyser will be listed separately. The analyser cannot be listed together with any reagents as part of a closed system. - Procedure for SPLIT Listing Requests (Existing Registered IVD Systems)
When the proposed changes involve only the application for a SPLIT listing option, Registrants shall contact HSA via email to obtain confirmation of eligibility for the SPLIT listing prior to submission. Upon receiving HSA’s confirmation, Registrants may proceed to submit a Change Notification under the category “Other Notification Changes (Verified by HSA prior to submission)”.
In cases where the proposed changes are identical (i.e., involving the same analyser or analysers to be removed from existing IVD system listings), Registrants may consolidate the affected device listings of the same risk class within a single Change Notification application.
Implications to Clients / Stakeholders
Revision 2 provides clearer guidance on IVD analyser classification, aligning with GN-14 and emphasizing the highest reagent risk class for closed systems. Under the new SMDR Listing Option 2, reagents and analysers must be listed separately, as analysers can no longer be listed with reagents as closed systems.
For SPLIT listings, stakeholders must obtain HSA confirmation of eligibility before submission and may group identical changes of the same risk class in one application.
Attachment / Link:
For more information, read the guidance document: [LINK]
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