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Health Sciences Authority
Regulatory Updates

Industry Briefing (September 2017)

Audiences

Healthcare professional

Industry member

Product type

Medical devices

11 September 2017

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

[Updated on 11 September 2017]

HSA has conducted an industry briefing on enhancements for IVD analysers on 11th September 2017.

The presentation slides are attached below:

HSA Industry Briefing_IVD analyser enhancements_SLIDES [PDF, 1542 KB]

The updated documents related to the enhancements are attached below:

 GN-34 Guidance Document for IVD Analysers_DRAFT [pdf]

 Annex 2 to GN-34_Compilation of compatible reagents with IVD analyser_DRAFT [xls]

For any comments or feedback on the above documents, please email us at hsa_md_info@hsa.gov.sg by 15 October 2017 using the feedback template attached below. Please indicate “Feedback on IVD analyser enhancements” in the email subject header.

 GN-34 Guidance Document for IVD Analysers_Feedback Template [xls]

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