The Singapore HSA has made a few minor changes to the guideline GN – 21 R4.6: Guidance on Change Notification and was published last February 2020 under the name GN – 21 R4.7. The revisions included are as follows:

  • Added “Bundling Together of Notification Changes in One Application” in the Notification Changes part under Categories of Changes section.
  • Revised a part of “Flowchart 1.2: Change in Sterilization Facility and its Process and/or Quality Management System” under Change Type Assessment Flowcharts section.
  • Revised a part of “Flowchart 2.1: Changes in Design or Specifications of an In Vitro Diagnostic (IVD) Medical Device” under Change Type Assessment Flowcharts section.
  • Revised “Flowchart 2.4: Change to Software of In Vitro Diagnostic Devices (IVD)” under Change Type Assessment Flowcharts section.
  • Added “Bundled Notification Changes” under Application Process for Change Notification section.
  • Revised some parts of “Change in Manufacturing Facility, Process and Quality Management System (QMS) table” underAnnex 1 to GN – 21: Change Notification Submission Requirements.
  • Revised a part of “Changes in Design or Specifications of a Registered Medical Device (GMD and IVD) table” under Annex 1 to GN – 21: Change Notification Submission Requirements.
  • Added an item in the “Documentation Guidelines for Software Changes table” under Annex 1 to GN – 21: Change Notification Submission Requirements.
  • Revised a part of “Change to Materials of In Vitro Diagnostic Medical Devices table” under Annex 1 to GN – 21: Change Notification Submission Requirements.
  • Revised a part of “Changes to Labelling table” under Annex 1 to GN – 21: Change Notification Submission Requirements.
  • Added an item to and revised a part of “Changes to Registered Medical Devices Listing Information” under Annex 1 to GN – 21: Change Notification Submission Requirements.
  • Revised a part of “Annex 2 to GN – 21: Summary Table of Change Notification”.

The details of the listed revisions of the guidelines can also be found in the following table:

Clarification through Visuals:

Table 1: GN – 21 R4.7 document screenshots showing the details of each revisions.

Item

Remarks

Added “Bundling Together of Notification Changes in One Application”

Added a new paragraph under the Notification Changes


Revision in Flowcharts 1.2, 2.1 and 2.4

Minor changes in the wordings in Flowchart 1.2


Minor changes in the wordings in Flowchart 2.1


Revised the entirety of Flowchart 2.4


Added “Bundled Notification Changes” comment

Minor addition regarding Bundled Notification Changes



Revision in Change in Manufacturing Facility, Process and Quality Management System (QMS) table

Minor revisions in accordance with Flowchart 1.2


Revision in Documentation

Guidelines for

Software Changes table

Added some minor notes.


Revision in Change to Materials of

In Vitro

Diagnostic Medical Devices table

Same with one of revisions of Change in Manufacturing Facility, Process and Quality Management System (QMS) table

Revision in Changes to Labelling table

Same with the revision in Change to Materials of In Vitro Diagnostic Medical Devices table

Revision in Changes to registered medical devices listing information table

Same with the revision in Changes to Labelling table


Added a check mark in the cell coinciding Letter of Authorisation row and 6Aiv column.

Revision in ANNEX 2 to GN – 21: Summary Table of Change Notification

Minor addition in Type of Changes column.

References:
Reference: GN-21-R4.7 Guidance on Change Notification for Registered MD(Feb-pub)

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