On September 4, 2025, the Health Sciences Authority (HSA) of Singapore issued Revision 2 of GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs). This revision aims to strike a balance between strengthening ethical safeguards for patients and easing operational demands on laboratories.
Scope
Guidance revision covering the use, regulation, and compliance obligations of Laboratory Developed Tests (LDTs) within Singapore’s licensed medical environment.
Key Points
Ethical Safeguards Strengthened
- Public advertising of LDTs is now prohibited, reinforcing that such tests may only be offered in licensed medical environments.
- Patients may only access LDTs under professional medical supervision, ensuring responsible test use.
Operational Requirements Simplified
- Removal of certain reporting requirements:
- Final Report submission within 21 days no longer required.
- Follow-up report submission (if Field Safety Corrective Action not completed by Day 21) no longer required.
- These changes reduce administrative pressure and streamline compliance obligations for laboratories.
Attachment
See the full guidance document here: GL-08 Revision 2 Regulatory Guidelines for LDTs (PDF).
Effective Date
4 September 2025
Implications to the Client
Revision 2 of GL-08 underscores the regulator’s dual priorities:
- Patient protection: By prohibiting direct-to-public promotion and restricting access to licensed facilities, the update ensures LDTs are used only under professional oversight.
- Practical compliance: By removing redundant reporting steps, laboratories can focus resources on patient care and corrective action implementation rather than administrative tasks.
Overall, these changes create a more responsible and efficient framework for LDT use in Singapore.
For further guidance on implementing these updates in your laboratory operations, please contact us at sales@andamanmed.com or click the button below.
