摘要
与人体健康相关的器械产品即本文所指的医疗器械边缘产品,涉及到人体生理数据的采集、监测,生理功能的调节,疾病症状的缓解等,事关民众的健康,随着产品种类和市场规模的增长,对其安全性和有效性的控制是监管部门面临的紧迫任务。监管部门需要首先明确其管理属性,以确定合理的监管政策。目前虽然有《医疗器械分类目录》等文件可作为部分医疗器械边缘产品的管理属性界定的依据,但仍不能涵盖该类所有的产品,监管工作中仍存在产品管理属性界定带来的问题,甚至存在监管漏洞,给制造商和使用者造成了困扰。本文首先从监管角度明确了医疗器械边缘产品的3种情形,分析了目前国际和我国与该类产品属性界定相关的法规、文件及监管政策情况,结合目前的产品特点,从工作机理、结构设计、应用场景和人群等关键要素进行详细分析,明确了各种产品作为医疗器械管理需具备的条件,对于其管理属性界定提出了技术建议,供业界参考。
The edge products of medical devices referred to herein involve the collection and monitoring of human physiological data,the regulation of physiological functions,and the relief of disease symptoms,which are related to the health of the public.With the growth of product types and market size,the control of their safety and effectiveness is an urgent task faced by regulatory authorities.The regulatory authorities need to first clarify its management attributes in order to determine reasonable regulatory policies.At present,although there are documents such as The Classification Catalogue of Medical Devices which can be used as the basis for the definition of management attributes of some edge products,it still cannot cover all such products.There are still issues with defining product management attributes in regulatory work,and even regulatory loopholes that have caused confusion for manufacturers and users.This paper first clarifies three situations of medical device edge products from regulatory perspective,and analyzes the current international and domestic relevant regulations,documents and regulatory policies.Combined with the current product characteristics,the key elements such as working mechanism,structural design,application scenarios and population were analyzed in detail,and the conditions required for various products to be used as medical device management are clarified.This paper puts forward technical suggestions for the definition of management attributes and provides reference for the regulatory authorities and industry.
作者
戎善奎
许慧雯
赵佳
余新华
RONG Shankui;XU Huiwen;ZHAO Jia;YU Xinhua(National Institutes for Food and Drug Control(Center for Medical Device Standardization Administration NMPA),Beijing 102629,China)
出处
《中国医疗设备》
2023年第8期154-160,共7页
China Medical Devices
关键词
医疗器械边缘产品
属性界定
管理现状
监管政策
edge products of medical devices
attribute definition
management status
regulatory policy
