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Health Sciences Authority
Regulatory Updates

Regulatory Guidelines for Laboratory Developed Tests (LDTs)

Audiences

Healthcare professional

Industry member

Product type

Medical devices

24 November 2022

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

Dear Stakeholders,

The Health Sciences Authority (HSA) would like to thank our stakeholders for your feedback on the Draft Regulatory Guidelines for Laboratory Developed Tests (LDTs) posted for consultation from 12 July 2022 to 12 August 2022.

HSA has updated the draft guidelines based on the various feedback and comments received during consultation and the finalised version can be accessed here:

GL-08-R1 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2023 Mar) PUB [PDF, 294 KB]

This guidelines will come into effect from 1 March 2023.

Thank you.

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