Regulatory Update: HSA Issues Notification on Regulatory Guidelines for Laboratory Developed Tests (LDTs)

The Health Sciences Authority (HSA) of Singapore has released the Regulatory Guidelines for Laboratory Developed Tests (LDTs), which are now accessible for public comment starting July 12, 2022. LDTs are classified as in vitro diagnostic tests (IVDs) under the Health Products (Medical Devices) Regulations. The revised recommendations apply specifically to LDTs that are produced and used within the same licensed clinical laboratory. The HSA will regulate test reagents and kits manufactured and used outside the clinical laboratory as commercial IVDs.

LDTs are governed by three main regulations: Product Control, Manufacturing Quality Control, and Post-Market Control.

1. Product Control: For registration with the HSA, only notification via is required. Laboratories must maintain a list of objective checks (see template in Appendix 1 of the draft guide) to consistently capture the specific information specified in the LDT and provide it to the HSA upon request. yang diperlukan. Laboratorium harus memelihara daftar pemeriksaan objektif (lihat template di Lampiran 1 dari panduan draf) untuk secara konsisten menangkap informasi spesifik yang ditentukan dalam LDT dan menyediakan informasi tersebut kepada HSA jika diminta.
2. Manufacturing Quality Control: The Ministry of Health (MOH) licenses clinical laboratories that manufacture and use LDTs for clinical diagnostic purposes as manufacturers under the Health Products (Safety) Act (HCSA). As a result, an HSA manufacturing license is not required. It is essential to obtain ISO 13485 certification from an approved Singapore Accreditation Council (SAC) organization or to utilize an appropriate laboratory accreditation program, such as SAC laboratory accreditation up to ISO 15189. Laboratories must ensure that LDTs are of consistent quality and performance. Additional responsibilities include active supervision and monitoring of LDT safety and performance, maintaining records of LDT production and clinical use, and documenting complaints and feedback from laboratory users. It is also necessary to notify the requesting entity when an internal LDT is being used.
3. Post-Market Control: Adverse event reporting must adhere to the guidelines outlined in the Health Products (Medical Devices) Regulations. Reporting of Field Safety Corrective Actions (FSCA) includes recalls within the timelines stipulated in the guidance, along with collaboration with the HSA for investigations and follow-ups on a case-by-case basis.

For more information, please visit the consultation page on the Regulatory Guidelines for Laboratory Developed Tests (LDTs) at hsa.gov.sg.