设计类医疗器械软件分类管理探讨  

Discussion on Classification Management of Design Medical Device Software

作　　者：戎善奎[1] 王晨希[1] 赵佳 余新华[1] RONG Shan-kui;WANG Chen-xi;ZHAO Jia;YU Xin-hua(National Institutes for Food and Drug Control(Center for Medical Device Standardization Administration),Beijing 102629)

机构地区：[1]中国食品药品检定研究院(国家药品监督管理局医疗器械标准管理中心),北京102629

出　　处：《中国医疗器械信息》2023年第7期1-3,23,共4页China Medical Device Information

摘　　要：当前设计类医疗器械软件主要用于辅助制定手术计划、设计医疗器械等,有多种重要用途,是一种比较特殊的软件,在监管工作中需要首先依据当前的相关法规明确此类产品管理属性。文章分析了设计类医疗器械软件产品的特点、目前产品的发展现状,结合我国和美国、欧盟的监管政策情况,根据《医疗器械分类目录》等法规并结合产品的使用风险,详细分析了对该类软件产品按照术前规划和生产加工两个不同的应用领域进行属性界定和管理类别划分的技术要求,并对应用新技术的该类软件的分类界定进行了探讨,从而为此类产品的监管工作提供技术参考。The current design medical device software is mainly used to assist in the formulation of surgical plans,design of medical devices,etc.It has many important uses and is a relatively special software.In the supervision work,it is necessary to first clarify the management attributes of such products according to the current relevant laws and regulations.This paper analyzed the characteristics of designed medical device software products and the current development status of the products,combined with the regulatory policies of China,the United States and the European Union,according to“The Classification Catalogue of Medical Devices”and other regulations and combined with the use risk of products.The technical requirements of attribute definition and management category classification of this kind of software products according to two different application fields of preoperative planning and production and processing are analyzed in detail,and the classification definition of this kind of software applying new technology is discussed,so as to provide technical reference for the supervision of this kind of products.

关 键 词：设计类医疗器械软件 手术计划 医疗器械设计 属性界定 类别划分 

分 类 号：TP319[自动化与计算机技术—计算机软件与理论]