Analysis and Suggestions on On-Site Inspection of Active Medical Device Manufacturers in Jiangxi Province
Objective To promote continuous improvement of the quality system of active medical device manufacturers.Methods The defect items found during on-site inspections of 83 active medical device manufacturers in Jiangxi Province during routine supervision and inspections from 2021 to 2022 were summarized,the main defects in the management of manufacturers were analyzed,and corresponding suggestions were put forward.Results During the on-site inspection,high-frequency defects were mainly distributed in equipment(16.37%),factory buildings and facilities(15.93%),document management(15.27%),and production management(12.83%).The main issues were the lack of factory building and equipment management,insufficient system documents,and the need for improvement in production management.Conclusion It is necessary to strengthen the supervision of the quality system operation of active medical device production manufacturers in Jiangxi Province,guide manufacturers to continuously improve their production and quality management levels,enhance their awareness of laws and regulations,and continuously improve the comprehensive ability of professional inspectors.
Jiangxi Provinceactive medical device manufacturerson-site inspectiondefect itemsanalysissuggestions
万方数据
维普
