Research and Discussion on the Supervision of Registration and Sales Units for In Vitro Diagnostic Reagents

This study reviewed the pre-market regulatory requirements, registration and filing status, as well as the actual sales and usage status of in vitro diagnostic reagent units from the perspective of full lifecycle supervision. A comparative analysis was conducted on the regulatory requirements of China, the United States, and the European Union for in vitro diagnostic reagent registration and sales units, with a focus on immune platforms, mass spectrometry platforms, and genetic testing products. This study analyzed the unit division and its risks in product classification and supervision, and provided regulatory recommendations to offer ideas and technical references for developing regulatory documents and supervising in vitro diagnostic reagent registration and sales units.