医疗器械标准在技术审评中的作用探讨

Role of Standards in Medical Device Evaluation

医疗器械标准是产品技术审评的重要参考之一。然而,对于标准在技术审评中的定位,以及如何充分发挥标准的技术支撑作用,迄今未见有专门论述。本文结合工作经验,对医疗器械标准在技术审评中的作用进行探讨,并提出意见和建议,供相关人员借鉴。

Medical device standards are important reference for evaluation of medical devices.However,there has been little study on the role of standards in medical device evaluation or on ways to give full play to the technical support of standards.This article was intended to discuss the role of standards in medical device evaluation based on the work experience of the author and offer recommendations for personnel concerned.