Evaluation Requirements and Reform Progress of in Vitro Diagnostic Reagents
In our country and many other jurisdictions,In-vitro diagnostic reagents are regulated as medical devices.Similar to other medical devices,the safety and effectiveness of these devices are evaluated and approved by regulators during pre-market technical reviews.In vitro diagnostic reagents have their own characteristics in the evaluation of their safety and effectiveness.This paper discusses the technical logic and supervision of pre-marketing safety and effectiveness evaluation of in vitro diagnostic reagents from the perspective of technical review,and briefly describes the Progress in reform and the current technical system of pre-marketing evaluation of in vitro diagnostic reagents in our country.
万方数据
维普
