Regulatory Updates
2 Dec 2019: Consultation on Medical Device Guidance Documents GN-21 and GN-34
Audiences
Healthcare professional
Industry member
Product type
Medical devices
2 December 2019
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Updated on 2 December 2019
The Medical Devices Branch (MDB) has recently updated two Guidance documents.
Key updates include:
- GN-21 Guidance on Change Notification
[NEW] Bundling of notification changes
[Update] IVD software flowchart
- GN-34 Guidance Document on IVD Analysers
[Update] Addition of Analysers flowchart
[Update] IVD software flowchart
[Update] GN-34 Annex 1 Declaration for Registered IVD Analysers in SPLIT IVD Analyser Device Listing(s)
We would like to invite our stakeholders to provide feedback on these documents:
GN-21-R4.7 Guidance on Change Notification for Registered MD(2Dec) For consult [PDF, 728 KB]
GN-34 R1.3 Guidance Document for IVD Analysers Industry For consult [PDF, 1007 KB]
The Consultation period for these documents is from 2 December 2019 to 3 January 2020. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 3 January 2020. Please indicate "Feedback on " in the email subject header.