REGULATORY UPDATE | The HSA has issued a notification about the Regulatory Guidelines for Laboratory Developed Tests (LDTs)

The Regulatory Guidelines for Laboratory Developed Tests (LDTs) document, released by the Health Sciences Authority of Singapore (HSA), is accessible for public comment from 12 July 2022 onwards. LDT is classified as an in vitro diagnostic test (IVD) under the Health Products (Medical Devices) Regulations. The revised recommendations apply only to LDTs produced and used in the same licensed clinical laboratory. HSA will regulate test reagents and kits manufactured and used outside the clinical laboratory as commercial IVD.

LDT is governed by three main regulations, namely Product Control, Manufacturing Quality Control, and Post-Market Control:

Product Control: For ESG registration with HSA, only notification via https://halp.moh.gov.sg/ is required. Keep a list of objective checks (see template in Appendix 1 of the draft guide) to consistently capture the precise information specified in the LDT and make it available to HSAs when requested.

Manudacturing Quality Control: The MOH licenses clinical laboratories that manufacture and use LDT for clinical diagnostic purposes as manufacturers under the HCSA. As a result, an HSA manufacturing license is not required. It is important to obtain ISO 13485 certification from an approved SAC organization or use an appropriate laboratory accreditation program such as SAC laboratory accreditation up to ISO 15189, etc. Ensuring that LDT is of consistent quality or performance Other duties and responsibilities include active supervision and monitoring of LDT safety and performance, keeping records of LDT production and clinical use, and keeping records of complaints and comments from laboratory users. Notify the entity that has requested the test that an internal LDT is being used.

Post-Market Control: : Adverse event reporting must follow the guidelines outlined in the HP (MD) Regulations. Field safety corrective action (FSCA) reporting includes recalls within the timelines stipulated in the guidance and working with HSA on investigation and follow-ups, case by case.¹

For more information, you can visit the destination at Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs) (hsa.gov.sg)