Abstract: Human leukocyte antigen (HLA) genotyping testing is a mandatory pre-transplantation procedure for organ transplantation and hematopoietic stem cell transplantation. The test results directly guide donor selection, design of immunosuppressive regimens, and post-transplant rejection monitoring. Therefore, to ensure the safety, efficacy, and quality control of HLA genotyping detection reagents registered for market authorization, the Center for Medical Device Evaluation of the National Medical Products Administration (NMPA) has recently released the Guidance for the Registration Review of Human Leukocyte Antigen (HLA) Genotyping Detection Reagents. To facilitate a better understanding of this guidance among relevant individuals, this article interprets the specific requirements for registration applications and technical reviews. These requirements cover intended use, methodology, sample types, accuracy, precision, limit of detection, performance indicators in Product Technical Requirements, and manufacturer's reference materials settings for such products.

Key words: Human leukocyte antigen, Genotyping, In vitro diagnostic reagents, Guidelines, Analytical performance, Registration review