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Singapore: Consultation on Regulatory guidelines for laboratory developed tests
- ARQon
- Sep 30, 2022
- 2 min read
Updated: Jan 4, 2023
A draft of the Regulatory Guidelines for Laboratory Developed Tests (LDTs) has been made available by the Medical Devices Cluster (MDC) for stakeholder consultation. Under the Healthcare Services Act, clinical laboratories are currently subject to MOH regulation and licensing (HCSA). Taking into account the present regulatory requirements that are applicable to clinical laboratories under HCSA, the regulatory approach for LDTs will be titrated based on the current regulatory standards applicable to commercial in-vitro diagnostic devices (IVDs).
The document gives a general overview of the application of LDTs and the appropriate regulatory standards, including post-market controls, manufacturing quality controls, and product controls.
HSA is inviting stakeholders to provide feedbacks on the document. The period for consultation of the document is from 12 July 2022 to 12 August 2022.Interested party must email their feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 12 August 2022. And also indicate "Regulatory Guidelines for Laboratory Developed Tests (LDTs)" in the email subject header.
LDTs are in vitro diagnostic tests (IVDs) that are:
developed and manufactured within a licensed clinical laboratory and solely for use within the same laboratory where it was developed, and
intended for specific clinical diagnostic use
In order to create a test system, a licensed laboratory requires generic reagents (such as antibodies, primers, probes, buffers, etc.) that can either be created or obtained from a commercial source (referred to as test). This test has been tested and validated in the lab and is meant for a particular clinical diagnostic purpose. When the test has been validated, it will be put into use only by this laboratory to conduct clinical diagnostic tests.
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