Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs)

12 July 2022 — Singapore Health Sciences Authority (HAS) announced the release of a draft regulatory guidelines for LDTs for stakeholders' consultation.

The document provides an overview of the scope of LDTs and the regulatory requirements applicable, which includes Product controls, Manufacturing Quality controls and post-market controls. The Consultation period for this document is from 12 July 2022 to 12 August 2022.

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