The HSA has finalized the regulatory guidelines for LDTs based on the stakeholder’s feedback on the draft regulation. The finalized guidance document can be found in the following link:
The mentioned guidance aims to provide clarity and assistance to clinical laboratories to understand the regulatory requirements applicable to LDTs under the Health Products Act (HPA) of 2007 and Health Products (Medical Devices) Regulations 2010 (HP MD).
LDTs are in vitro diagnostic (IVD) tests that were developed in-house by the laboratories that are licensed by the Ministry of Health (MoH). Up until now, LDTs are not regulated by the HSA unlike commercial IVDs. The regulation for LDTs is based on the current regulations for IVDs as well as the existing regulatory requirements for clinical laboratories under the Healthcare Services Act (HCSA).
LDTs are IVDs that are:
- ● developed and manufactured within a licensed laboratory for use in that same laboratory
- ● intended for specific clinical diagnostic use
Example would be a reagent that is being used by a licensed laboratory for a specific instrument. Once the method that uses this reagent is verified and validated by the laboratory, this will be used specifically for the said laboratory. However, if the LDT is supplied to facilities outside the laboratory, it will no longer qualify as an LDT and it will be subject to regulatory requirements under HPA.
The overview of the regulatory controls for LDTs can be divided into three (3) broad categories:
- ● Product – LDTs are not subject to product evaluation and registration by HSA. Instead, the laboratory will notify them to the MoH’s licensing portal, the Healthcare Application and Licensing Portal (HALP). Clinical laboratories are responsible and are required to ensure that their LDT continues to be safe and effective for clinical use. Laboratories are required to systematically document specific prescribed information regarding their LDT in an objective checklist that must be updated periodically and maintained by the laboratory and shall be submitted for review when required by HSA.
- ● Manufacturing Quality – laboratories that use LDTs are considered as manufacturers and therefore must have a Quality Management System (QMS) in place. However, since they are already licensed under the HCSA by MOH, they will not be required to secure a manufacturer’s license from the HSA. The laboratories must also ensure the quality/performance of the LDT on an on-going basis. Appropriate record of each batch of the LDT manufactured must be maintained to ensure traceability.
- ● Post-Market – the ones stated in the HPA and HP MD are also applicable to LDTs. This includes reporting the Adverse Events (AEs) and Field Safety Corrective Actions (FSCAs), including recalls, associated with the use of the LDT to HSA. However, the HSA will monitor the post- market activities that is being conducted by the laboratory.