Analysis of Common Problems in Classifcation of Medical Devices

Objective The present study was designed to analysis some misunderstanding on "medical devices classification rules" of CFDA, in order to correct understand and use the regulation. Methods The contents of "medical devices classification rules" by CFDA have been analysis and generalized. Results Through analyzing, we can conclude as followed:the priority principle of classification catalogue; the comprehensive judgment principle based on the classification decision table and special classification principles; medical devices' management class could be changed by CFDA according to risk analysis results. Conclusion It is helpful to reach an agreement on the classification of a medical device among the regulatory authorities, production enterprises and other aspects, and establish a solid foundation for CFDA's regulatory science.