Medical network - on March 15, 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 administration organization of metal spine screws, metal spinal rod 2 varieties 122 batch of product quality supervision and checking. Now the sampling results announcement is as follows:
One, by sampling project does not meet the prescribed standards of medical equipment products, 1 involves a variety of medical device manufacturing enterprise 1 batch. Specific as follows:
Metal rods spine companies 1 batch of products. Pioneer Surgical Technology, Inc., the production of one batch (end - orthopaedic spinal fixation system bar, hexagonal), size does 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.
Project 2, sampling all conform to the standards of medical equipment products involving 60 medical device manufacturing enterprise of two varieties 121 batch, 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.
Relevant dealing with medical device manufacturing enterprise 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 provincial food and drug supervision and administration authority to supervise enterprise recall situation not organize recall shall be ordered to recall; Provided is not in conformity with the standards of medical equipment products cause harm to human body or there is evidence that may endanger human body health, should be taken to suspend the production, import, 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, about disposal to publish to the society before April 14, 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
2. The national medical equipment conforms to the standard product list
The food and drug supervision bureau
On March 10, 2017 |
