On November 20, 2023, the Health Sciences Authority (HSA) Singapore revised the guidance document on Change Notification applications due to EU MDR and IVDR-related changes to registered medical devices.
The identified changes clarified in this update are the following:
- 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.
- Furthermore, the HSA said that change notification applications for IVDs may be filed under Change Type 5E Notification, IF:
- Changes do not impact indication of use AND
- Changes are covered under previously submitted pre-clinical/clinical validation data.
For details, please refer to this documentation.
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