Medical network - July 11, in order to strengthen quality supervision and management of medical equipment, to ensure the safety of medical equipment products use effective, administration of the state food and drug supervision and management organization of the disposable use asepsis vaginal dilators a variety of 94 batches of product quality supervision and checking. Now the sampling results announcement is as follows:
A, by sampling project does not meet the prescribed standards of medical equipment products, involving five a variety of medical device manufacturing enterprise 9 batches. Specific as follows:
The disposable use asepsis vaginal dilator 5 companies 9 batch products. Zibo to mio medical equipment co., LTD production of 1, nanchang xu hui medical equipment co., LTD., production batch 1 batch, nanchang happy medical equipment co., LTD and nanchang xiang yi medical instrument co., LTD. Production of the 2 batches disposable use asepsis vaginal dilator, resistance to deformation ability does not conform to the prescribed standards; Nanchang kang jie medical health products co., LTD., the production of 3 batches of disposable use asepsis vaginal dilator, resistance to deformation ability is not in conformity with the prescribed standards, including 2 batches sterile do not conform to the prescribed standards.
The specific situation of the above sampling does not conform to the stipulations of the standard products, see appendix 1.
Second, sampling project all conform to the standards of medical equipment products involving 34 a variety of medical device manufacturing enterprise 85 batches, see appendix 2.
Three, found in the above sampling does not conform to the standard products, the state food and drug administration has asked enterprises to local food and drug supervision and administration authority in accordance with the regulations on the supervision and administration of medical devices and the food and drug supervision bureau general office notice on further strengthening medical instrument sample work for drug safety (food do machinery supervisor [2016] 9), to investigate the related enterprises.
Related to medical device manufacturing enterprise in after receiving the inspection report, should immediately to does not conform to the stipulations of the standard products, does not conform to the stipulations of the standard project risk assessment, according to the severity of the medical equipment defect level of recall, is voluntarily recalling and public recall information. Enterprise local food and drug supervision and administration authority to supervise enterprise recall situation did not recall shall be ordered to recall, such as found that do not conform to the standard of medical equipment products cause harm to human body or there is evidence that may endanger human body health, can take to suspend production, management, use of emergency control measures. Relevant provincial food and drug supervision and administration department to supervise and urge enterprises to find out the reason as soon as possible, formulate corrective actions and timely rectification in place, the disposal situation announced to the public on July 31, 2017.
Notice is hereby given that the.
Attachment: 1. The national medical instrument sampling does not conform to the stipulations of the standard product list
