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.
ABSTRACT
This paper discussed the selection of SCI journals and questions associated with submitting manuscripts.The strategy for the submitting manuscripts.and the problems in the publication of manuscripts were also summarized in this article.These results would be valuable and guide for the researchers to submit their manuscripts,conform the writing skills of scientific papers,and improve the efficiency of SCI publications.