含抗菌剂医疗器械申报资料中临床前部分常见问题的思考

Consideration for the Common Problems of the Preclinical Part in Medical Devices including Antimicrobial Agents Registration

该文对含抗菌剂医疗器械申报资料中临床前部分的常见问题进行了归纳和分析,以期为我国研究人员和生产企业在研发和申报注册该类产品时提供参考。

This article summarizes and analyzes the common problems of the preclinical part in medical devices including antimicrobial agents registration.It is hoped to be helpful for researchers and manufacturers in the registration of medical devices including antimicrobial agents.