Abstract: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.
郑源源,冯靖祎. 国产无创动态血压监测设备注册情况研究[J]. 中国医疗设备, 2023, 38(3): 166-170.
ZHENG Yuanyuan, FENG Jingyi. Study on the Registration of Domestic Non-invasive Ambulatory Blood Pressure
Monitoring Device. China Medical Devices, 2023, 38(3): 166-170.