Last month, Singapore’s HSA provided a draft guideline on LDTs. This guideline stated that LDTs used as IVDs or for RUO are not classified as LDTs. LDTs are tests that are only developed and used by labs at their own sites. Labs that develop LDTs are licensed under the Singapore HSA. LDTs must meet relevant quality management systems as well as post-market requirements.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.hsa.gov.sg/announcements/regulatory-updates/regulatory-guidelines-for-laboratory-developed-tests-(ldts)#:~:text=The%20Health%20Sciences%20Authority%20(HSA,2022%20to%2012%20August%202022.&text=This%20guidelines%20will%20come%20into%20effect%20from%201%20March%202023.