Singapore: HSA Released Draft Regulatory Guidelines for Laboratory Developed Tests (LDTs)
Health Sciences Authority (HSA) Singapore has published a new guidance document ‘Regulatory Guidelines for Laboratory Developed Test (LDTs)’ which is opened for public consultation with industry stakeholders, from 12 Jul 2022. LDTs are considered in vitro diagnostic tests (IVDs) as defined in Health Product (Medical Device) (HP(MD)) Regulations.
The scope of the new guidance encompasses LDTs developed and used only in the same licensed clinical laboratory. Test reagents and kits developed and used outside the clinical laboratory will be regulated as commercial IVD by HSA.
The three main regulatory controls for LDTs are:
(A) Product controls
- Registration of LDTs with HSA is not required, only notification via https://halp.moh.gov.sg is necessary.
- Maintaining an objective checklist (refer to template in Annex 1 of the draft guidance) to consistently record specific prescribed information of LDT and make available when requested by HSA.
(B) Manufacturing quality controls
- Clinical laboratories that develop and use LDTs for clinical diagnostic purposes are manufacturers and are licensed under the HCSA by MOH. Therefore, a manufacturing license with HSA is not required.
- Implementation of Quality Management System by having certification from accredited SAC bodies to ISO 13485 or leveraging on relevant laboratory accreditation programs such as SAC laboratory accreditation to ISO 15189 etc is required.
- Ensure consistent quality or performance of LDT.
- Includes other duties and obligations such as active surveillance and monitoring of the safety & performance of LDTs, maintaining records of manufacture & clinical use records of LDTs and maintaining records of complaint & feedback from the laboratory users.
- Inform entities requesting tests that in-house LDTs have been used.
(C) Post-market controls
- Reporting of Adverse events to adhere to that prescribed in HP (MD) Regulations
- Field safety corrective action (FSCA) reporting including recalls timelines stipulated in Guidance and to work with HSA on investigation and follow-ups, case by case.
For full details of the draft guideline, please refer to attachment . The consultation period ends on 12 August 2022. Please email your feedback using the prescribed feedback form in attachment  to [email protected] by 12 August 2022. Please indicate “Regulatory Guidelines for Laboratory Developed Tests (LDTs)” in the email subject header.
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