At present,the medical device market in Gansu Province is not large,with a small number of production enterprises and a small scale of operating enterprises.The technological innovation,product replication,and research and development capabilities are weak,and there is a lack of scientific research talents and technical labor.In order to effectively improve the inspection and testing capabilities of medical device production enterprises in the province and comprehensively strengthen the quality management of medical devices,the Provincial Medical Device Institute follows relevant laws,regulations,standards,and normative documents related to medical devices,Based on the actual production of medical devices in our province,in 2023,a survey was conducted on the inspection and testing capabilities of medical device production enterprises in the province.The research team conducted research on medical device production enterprises in Wuwei,Jinchang,Tianshui,Longnan,Baiyin,Linxia Prefecture,Lanzhou,and Lanzhou New Area through on-site inspections,inquiries,inspection reports,product technical requirements,and system documents,and suggestions were put forward to strengthen the self inspection ability of enterprises based on actual situations.