Member Article

In recent years, China is continuously exploring the regulations of LDT (Laboratory Developed Tests, as defined below). With the introduction of a series of new regulations, many outstanding multinational and local companies have participated in the research of LDT. At this stage, general provisions can no longer meet the demand of the practice of LDT industry. Recently, Shenzhen, Guangzhou, Hangzhou, Beijing and Shanghai have successively introduced favorable policies to support the development of LDT. In early 2023, the National Medical Products Administration of PRC ("NMPA") and the National Health Commission of PRC ("NHC") jointly issued the Notice of Carrying Out the Pilot Program of Development and Use of Medical Institution Developed In Vitro Diagnostic Reagents ("National LDT Pilot Regulations"). In March, Shanghai MPA and Shanghai Health Commission jointly issued the Implementation Plan for the Pilot Program of Development and Use of Medical Institution Developed In Vitro Diagnostic Reagents ("Shanghai LDT Pilot Regulations"). The introduction of National LDT Pilot Regulations and Shanghai LDT Pilot Regulations marks the beginning of the implementation stage of China's regulation on the LDT industry, thereto making the regulatory methodology clearer and taking a significant step to a more comprehensive and mature regulatory system in the future. This article will introduce the key aspects of the National LDT Pilot Regulations and Shanghai LDT Pilot Regulations and make comparison on the commonalities and differences between the two regulations, for the purpose of providing reference for the industry.