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Health Sciences Authority
Regulatory Updates

Revision to Medical Devices Change Notification Guidance

Audiences

Healthcare professional

Industry member

Product type

Medical devices

25 November 2015

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

[Updated on 25 November 2015]

The Medical Device Branch (MDB) has updated the guidance documents on the Change Notification for Registered Medical Devices to streamline the change notification system. The revised documents will take effect from 1 December 2015, and will only be applicable for change notification applications submitted from this date onwards.

The revised guidance documents are attached below:

GN-21-R4 Guidance on Change Notification for Registered Medical Devices [pdf]

GN-21 Annex 2 Summary Table of Change Notification [doc]

GN-21 Annex 3 Medical Device Safety and Performance Declaration Template [doc]

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