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Archived Regulatory Guidances

Here is the list of archived regulatory guidance documents.

GN-21-R4.9 Guidance on Change Notification for Registered MD [ARCHIVED on 06 Mar 2023]649 KB

GN-14-R2 Guidance on the Risk Classification of In Vitro Diagnostic MD [ARCHIVED on 24 Jul 2023]516 KB

GN-16-R3 Guidance on Essential Principles for Safety and Performance of Medical Devices [ARCHIVED on 08 Sep 2023]407 KB

GN-16-R2 Guidance on Essential Principles for Safety and Performance of Medical Devices [ARCHIVED on 22 Sep 2022]449 KB

GN-21-R4.8 Guidance on Change Notification for Registered MD [ARCHIVED on 25 Apr 2022]847 KB

GN-23-R1-1 Guidance on Labelling for Medical Devices [ARCHIVED on 22 Sep 2022]521 KB

GN-21-R4.7 Guidance on Change Notification for Registered MD [ARCHIVED on 26 Mar 2021]1301 KB

GN-21-R4.6 Guidance on Change Notification for Registered MD [ARCHIVED on 17 Feb 2020]1032 KB

GN-23-R1 Guidance on Labelling for Medical Devices [ARCHIVED on 1 Mar 2020]354 KB

GN-21-R4.4 Guidance on Change Notification for Registered Medical Device [ARCHIVED on 31 Mar 2019]1178 KB

GN-21-R4.5 Guidance on Change Notification for Registered Medical Devices [ARCHIVED on 30 Apr 2019]1208 KB

GN 13-R1.1 Guidance on the Risk Classification of General Medical Devices [ARCHIVED on 31 May 2018]933 KB

GN 14-R1.2 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices [ARCHIVED on 31 May 2018]429 KB

GN 16-R1.2 Guidance on Essential Principles for Safety and Performance of Medical Devices [ARCHIVED on 31 May 2018]457 KB

GN 21-R4.2 Guidance on Change Notification for Registered Medical Devices [ARCHIVED on 31 May 2018]1073 KB

GN 23-D1.1 Guidance on Labelling for Medical Devices [ARCHIVED on 31 May 2018]653 KB

GN 21-R4.3 Guidance on Change Notification for Registered Medical Devices [ARCHIVED on 20 Aug 2018]1048 KB

GN-13-R2 Guidance on the Risk Classification of General Medical Devices [ARCHIVED on 25 Sep 2018]586 KB

Last updated: 31 Dec 2018