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The MPA named 28 batches of unqualified medical equipment!

2023-04-24

On April 20, Jiangsu MPA released the Notice on the Quality of Jiangsu 2022 Phase 2 Medical Devices and Medicine Packaging Materials.

 

According to the notice, the Jiangsu MPA has organized a sampling inspection of the manufacturers, distributors and users of medical devices, and made public the information of 28 batches of non-conforming medical devices found in the sampling.

These include: the blood glucose monitor produced by Guilin Zhonghui Technology Development Co., LTD., the disposable sterile vaginal dilator produced by Wuhan Qiuyu Medical Equipment Co., LTD., the disposable catheter produced by Suzhou Yaxin Medical Supplies Co., LTD., the traction bed produced by Nantong Medical Equipment Co., LTD., and so on.

For the above unqualified products, MPAs at all levels in Jiangsu Province have urged enterprises to carry out risk assessment on related products, determine the recall level according to the severity of defects, take the initiative to recall products and disclose the recall information; At the same time, urge the enterprise to find out the cause of unqualified products as soon as possible, formulate rectification measures and rectification in place on schedule. MPAs at all levels in Jiangsu Province have organized legal investigations and punishments against units engaged in the production, operation, and use of non-conforming products.

Source:中国质量新闻网 (cqn.com.cn)

Translated & edited by Bradyknows