Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs)

The Medical Devices Cluster (MDC) has released a draft Regulatory Guidelines for Laboratory Developed Tests (LDTs) for stakeholders' consultation. Clinical laboratories are currently regulated and licensed by MOH under the Healthcare Services Act (HCSA). The regulatory approach for LDTs will be titrated based on the current regulatory requirements applicable to commercial In-Vitro Diagnostic Devices (IVDs) taking into consideration the existing regulatory requirements that are applicable to clinical laboratories under HCSA.

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. We would like to invite our stakeholders to provide feedback on this document:

[For Consult] Regulatory Guidelines for Laboratory Developed Tests (LDTs)534 KB

The Consultation period for this document is from 12 July 2022 to 12 August 2022. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 12 August 2022. Please indicate "Regulatory Guidelines for Laboratory Developed Tests (LDTs)" in the email subject header.

guidance-feedback--form14 KB

Published: 12 Jul 2022

Regulatory Updates