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Singapore: HSA Shares Revisions on Change Notification Guidelines Following EU MDR and IVDR Changes

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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