Medical network - Dec. 2, 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 latex rubber condoms, soft contact lens, five varieties such as disposable venous indwelling needle 184 (sets) 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 7 8 batches of 4 varieties from the medical device manufacturing enterprise. Specific as follows:
(a) soft contact lens companies 1 batch products. Crystal optical co., LTD., the production of 1 batch to recognize soft hydrophilic contact lens, ultraviolet area requirement (when applicable) do not conform to the prescribed standards.
(2) the disposable use asepsis vaginal dilator 2 companies in 3 batches. Shaanxi fuyuan medical plastic co., LTD. Production of 2 batches, jiangxi merchant medical equipment group co., LTD. Production of 1 batch disposable use asepsis vaginal dilator, appearance does not conform to the prescribed standards.
(3) natural latex rubber condom companies 2 batches. Hebei winnie DE rubber products co., LTD, maoming snowland latex products co., LTD. 1 batches of the production of natural rubber latex condoms, without aging blasting volume and burst pressure, pinhole does not conform to the prescribed standards.
(4) disposable venous indwelling needle companies 2 batches. Xinxiang camel person disposable medical instrument co., LTD., production 1 batch venous indwelling needle, uv absorbance does not conform to the prescribed standards; Jiangsu YangPu medical technology co., LTD. Production of 1 batch disposable venous indwelling needle, velocity does not conform to 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 four two varieties of 4 batch of medical device manufacturing enterprise (Taiwan), specific as follows:
(a) type B ultrasound diagnostic equipment 2 sets products for 2 companies. Yixing Wan Kang medical electronics co., LTD. Production of 1 full digital color doppler ultrasonic diagnostic apparatus, Beijing hui shadow interconnection technology co., LTD. Production of 1 digital color doppler ultrasonic diagnosis system, specifications do not conform to the prescribed standards.
(2) natural latex rubber condom companies 2 batches. Qingdao double butterfly group co., LTD., ShiMeng latex (tianjin) co., LTD. 1 batches of the production of natural rubber latex condoms, packing and marking is not in conformity with 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 involved in a variety of 172 batches, 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 case on December 30 2016 publish to the society. |
