Medical network October 26 - 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 natural rubber latex condoms, medical surgical masks and other four varieties of 185 batches of product 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 four medical device manufacturing enterprise of two varieties of 4 batches. Specific as follows:
(a) type 3 companies in 3 batches of products. Xinxiang hua kang eisai co., LTD., xinxiang amidst a medical equipment co., LTD 1 batch production of disposable gown, [resistance microorganisms penetrate, wet) do not conform to the prescribed standards; Henan blue sky medical equipment co., LTD production of disposable sterile gown, 1 batch (resistance microorganisms penetrate, wet), anti-water permeability (product key areas) do not conform to the prescribed standards.
(2) medical surgical masks companies 1 batch products. Xinjiang new WeiYuan medical instrument co., LTD., production 1 batch medical surgical masks, filtering efficiency, gas exchange (pressure difference Δ p) does not comply with the prescribed standards.
Above sample does not conform to the stipulations of the standard product details see appendix 1.
2, sample projects all conform to the prescribed standards for medical devices involved 57 medical device manufacturing enterprise of two varieties 181 batches, see appendix 2.
Three, 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 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 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, about disposal on 30 November 2016 to publish to the society.
Notice is hereby given that the.
The food and drug supervision bureau
On October 19, 2016 |
