对《医疗器械临床评价技术指导原则》的思考

Thinking about the Principles Guideline of Clinical Evaluation of Medical Devices

结合国内临床评价监管法,探讨每条临床评价路径的操作性和可行性;为医疗器械生产企业在产品注册时开展临床评价和完成临床评价资料时提供参考。

Combined with the clinical evaluation supervision laws, discusses the operation and feasibility of each path for clinical evaluation, to provide reference for the medical devices’ sponsors in the product registration period carrying out clinical.