Objective:Focusing on the key risk points affecting the quality of medical devices,and at the same time putting forward corresponding measures and opinions and suggestions to manufacturers and drug regulatory authorities.Methods:Collect and collate medical device sampling and testing information notified on the official website of Guangdong Provincial Drug Administration from 2020 to 2023,and analyse the failure of sampled medical devices in Guangdong Province from 2020 to 2023.Results:From 2020 to 2023,Guangdong Provincial Drug Administration has notified the results of 21 issues of medical device sampling and testing,with a total of 7116 batches of medical devices,of which 326 batches were unqualified in 11 issues.The sampling test results were statistically sorted out and analysed in two dimensions,namely,the situation of unqualified items of products and the situation of unqualified item categories,and corresponding measures and suggestions were proposed to medical device manufacturers and drug regulatory authorities.Conclusion:Sampling inspection of medical devices is a key link in the regulatory system,successfully linking the entire regulatory chain of medical devices from registration to production,operation,and use.The drug regulatory authorities should further provide guidance on evaluation and promote standards,and strengthen the handling of problematic products and enterprises.
medical equipmentsampling inspectionanalysis of non-conformitiesquality status
维普
万方数据
