Revision and Key Points Interpretation of the In Vitro Diagnostic Reagent Classification Catalogue of NMPA
Objective:This paper introduces the revision background and process of the In Vitro Diagnostic Reagent Classification Catalogue of NMPA,along with an interpretation of key modifications,aiming to help in vitro diagnostic(IVD)manufacturers and regulators accurately understand the new catalogue changes and unify classification management supervision standards across China.Methods:By referring to classification documents from Europe and the United States,the new framework for the new classification catalogue was constructed based on the Classification Rules of In Vitro Diagnostic Reagents.Existing registered and recorded IVD data were reviewed and sorted,merging similar products,standardizing category names,and removing products not compliant with the new classification rules.Unified principles for revision were established.For challenging and disputed issues,literature reviews and expert consultations were conducted,with explanations provided in the interpretation documents.Results:A new In Vitro Diagnostic Reagent Classification Catalogue of NMPA has been established,including 25 first-level product categories and 1852 second-level product categories,covering Class Ⅰ,Ⅱ and Ⅲ ⅣD reagents.Conclusion:The new catalogue summarizes over a decade of experience in ⅣD reagent classification supervision in China.Its release and implementation will have a positive effect on the standardization of ⅣD reagent classification,the application of classification rules,and promote high-quality development of China's ⅣD industry.
in vitro diagnostic reagentclassification cataloguerevisioninterpretationclassification rules
万方数据
维普
