On 22nd November, 2022 Singapore's Health Sciences Authority released the final Regulatory Guidelines for Laboratory Developed Tests (LDTs).
Under the Health Products Act 2007 (HPA) and Health Products (Medical Devices) Regulations 2010 (HP (MD) Regulations), this document provides guidance and clarity to assist clinical laboratories in understanding the regulatory requirements for Laboratory Developed Tests (LDTs).
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.
The regulatory controls for LDTs can be divided into three broad categories:
Product Controls
Manufacturing Quality Controls
Post-market Controls
Licensed clinical laboratories are required to follow this guideline for all LDTs (i.e. products, including test reagents, and kits) developed within their laboratories solely for internal use. Test reagents and kits developed within a licensed clinical laboratory and distributed outside of the laboratory where they were developed will be regulated as commercial IVD products by the HSA.
Click this LINK to know more about the regulatory controls LDTs in detail. This guideline will come into effect from 1 March 2023.