Regulatory Guidelines for Laboratory Developed Tests (LDTs)

24 November 2022 – Singapore Health Sciences Authority (HSA) issued revision one of its regulatory guidelines for LDTs.

This document provides guidance and clarity in assisting clinical laboratories on understanding the regulatory requirements applicable to Laboratory Developed Tests (LDTs) under the Health Products Act 2007 (HPA) and Health Products (Medical Devices) Regulations 2010 (HP (MD) Regulations).

Guidelines will be effective beginning March 2023.

Read the pdf 
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