ISO 13485:2016标准全面融入我国医疗器械法规解读与分析

Interpretation and Analysis on Fully Incorporating Applicable Regulatory Requirements of Medical Devices in China within ISO13485:2016

本文结合我国医疗器械法规体系,解读分析了如何在标准实施过程中全面融入相关法规要求。

This paper Interpretates and analysizes on how to fully incorporate relevant regulatory requirements within implementation process of ISO13485：2016 by Combining with the medical device regulatory system in china.