Medical network - December 30, 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 hemodialysis and related treatment with concentrate, 53 of medical electrical equipment, and six varieties of traditional Chinese medicine (Taiwan) products of quality supervision to sample. Will now oversee the result announcement is as follows:
One, is to sample project does not meet the prescribed standards of medical equipment products, involving 1 a variety of medical device manufacturing enterprise 1. Specific as follows:
The doctor of traditional Chinese medicine diagnosis and treatment of electrical equipment companies 1 products. Chengdu huaxin high-tech medical equipment co., LTD production including one meridian therapeutic apparatus, the operating unit of the controller is not in conformity with the prescribed standards.
Above sample does not conform to the stipulations of the standard product details, see appendix 1.
Labels are sample project for the identity, specifications do not conform to the prescribed standards of medical equipment products, involving two medical device manufacturing enterprise of two varieties 5 batch (Taiwan), specific as follows:
(a) disposable infusion infusion of gravity type 1 (with needle) 4 batch products. Jiangxi merchant medical equipment group co., LTD. Production of disposable infusion needle, 4 batch single packaging does not conform to the prescribed standards.
(2) the doctor of traditional Chinese medicine diagnosis and treatment of electrical equipment companies 1 products. Chengdu huaxin high-tech medical equipment co., LTD production including one meridian therapeutic apparatus, random file does not conform to the prescribed standards.
Above sample does not conform to the stipulations of the standard product details, see the attachment 2.
Three, sample project all conform to the prescribed standards for medical equipment products involve four varieties of 48 (Taiwan), see appendix 3.
Four, found in the above sample 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 work on further strengthening medical equipment of proper notice (food drug safety office 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 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, can 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, the disposal of the situation in January 2017, 30 publish to the society.
Notice is hereby given that the.
Attachment: 1. The national medical apparatus and instruments to sample does not conform to the stipulations of the standard product list
2. The national medical apparatus and instruments to sample (logo label instructions, etc) do not conform to the standard product list
3. The national medical apparatus and instruments to sample with standard product list |
