国产无创动态血压监测设备注册情况研究

Study on the Registration of Domestic Non-invasive Ambulatory Blood Pressure Monitoring Device

本文对国家药品监督管理局公开的国产无创动态血压监测设备的医疗器械注册证数据进行定量分析,从而探究行业的发展现状。统计结果显示,截至2022年7月23日,有效的国产无创动态血压监测设备注册证为47项,共有36家生产企业遍布全国各地,但其中26家为小微企业。在注册证数目方面,有28家企业仅有1项注册证。依据示波法进行血压监测的设备较多,而利用脉搏波法、扁平张力法、恒定容积法的产品较少,且大部分产品的测量参数仅有血压值1项。总体呈现出同质化较高、生产企业规模较小、创新型产品较少的特点,市场竞争较为激烈。本文旨在为相关从业人员了解行业现状提供参考,未来将进一步比对国产和进口无创动态血压监测设备的注册情况,分析国产设备的市场规模和占有情况。

The medical device registration certificate data of domestic non-invasive ambulatory blood pressure monitoring equipment on website of National Medical Products Administration is analyzed in this study to explore the development status of the industry.Statistics showed that as of July 23,2022,there were 47 valid registration certificates for domestic non-invasive ambulatory blood pressure monitoring equipment,and 36 manufacturers across the country,but 26 of them were small and micro enterprises.In terms of the number of registration certificates,28 companies had only one registration certificate.There were many devices for blood pressure monitoring based on the oscillometric method,while there were few products using the pulse wave method,the flat tension method,and the constant volume method,and in most cases,most of the products only had one parameter of blood pressure.Overall,it shows the characteristics of high homogeneity,small scale of production enterprises,and few innovative products,and the market competition is relatively fierce.This article aims to provide a reference for practitioners to understand the current situation of the industry.In the future,the registration situation of domestic and imported equipment will be further compared,and the market size and occupation of domestic equipment will be analyzed.