关于眼科手术系统安全性、有效性评价要求的思考

摘要

This article introduces optical surgery systems comprehensively, considers the evaluation of their safety and effectiveness and gives some opinions on technical review. It is hoped to be helpful for optical surgery systems registration and technical review.%本文对眼科手术系统进行简单的介绍，对其注册申报时安全性、有效性的评价要求进行思考，从技术审评的角度提出看法，以期对眼科手术系统的注册及技术审评有所帮助。