Singapore: HSA change notification related to EU MDR/IVDR to registered medical devices
European Union (EU) is one of HSA’s five reference regulatory agencies commonly referenced in abridged evaluation route for medical device registration. With EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR), the related changes will impact existing registered medical devices, especially IFU and labels. This document serves to provide clarity on HSA’s position on change notification applications related to EU MDR and IVDR updates. This document will be effective until end of 2025.
For changes that do not fall within the covered scope and criteria in the subsections of this document, approach as prescribed in GN-21: Guidance on Change Notification for Registered Medical Devices will apply.
Revised Approach specific to changes arising from the EU MDR/IVDR
Changes to label and IFU with no new information related to safety and performance (GMD and IVD)
Changes to label and IFU related to material “-Free” claims (GMD)
Changes to IFU related to clarification of existing content and addition of safety information (GMD and IVD)
Changes to IFU (IVD) related to clarification of performance data
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