Singapore HSA Published Document Relating to Change Applications Arising from the EU MDR/IVDR related changes to registered medical devices

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 more info:: https://www.hsa.gov.sg/announcements/regulatory-updates/change-notification-applications-arising-from-the-eu-mdr-ivdr-related-changes-to-registered-medical-devices