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Change Notification applications arising from the EU MDR/IVDR related changes 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. The document can be accessed here.

For feedback and enquiries relating to the document, please email to:

Consumer, Healthcare professional, Industry member, Medical devices

Regulatory Updates