As an important part of medical devices, in vitro diagnostic reagents are important means to prevent and diagnose and protect people's health. Supervision and sampling is an important and key supervision method to ensure the in vitro diagnostic reagent products are qualified. This paper summarizes the problems encountered in recent years in vitro diagnostic quantitative testing kit supervision sampling, analyzes the causes of these problems, and puts forward corresponding suggestions, hoping to provide constructive suggestions for supervision sampling.
Keywords: IVD; in vitrodiagnosis; supervision and sampling inspection.