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Singapore: Fifth Revision of GN-21: Guidance On Change Notification For Registered Medical Devices

The Health Sciences Authority (HSA) of Singapore issued a fifth revision of GN-21: Guidance on Change Notification for Registered Medical Devices. This new revised guidance has been made effective starting March 07th 2023.

With this revised guidance, it is informed that the Safety and Performance Declaration will no longer be required for Change Notification submission. For further information on the revised guidance, please visit the link here.

If you have any queries regarding the announcement, please get in touch or click the button below.

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