Common problems analysis of domestic Class II active medical devices registration in China / 医疗卫生装备

ABSTRACT

Objective To improve the quality of registration and reporting and the efficiency of examination and approval of ClassⅡactive medical devices in China.Methods Classification analysis of common problems in the submitted materials was executed based on the requirements of new laws and regulations for ClassⅡactive medical devices and the experience, and then some measures were put forward with considerations on the new laws and regulations. Results The common problems in the registration and submitting of ClassⅡactive medical devices were described in detail,and some counter-measures were brought out based on the laws and regulations related to provide guidance for other enterprises.Conclusion The enterprise has to study related laws,regulations,standards and guidance when executing registration and application,so that the quality of submitted materials can be enhanced to facilitate the evaluation and approval of ClassⅡactive medical devices.