dialysis machine

English translation: Manufacturing License Issued by Shandong Food & Drug Administration

13:48 Nov 25, 2014
Chinese to English translations [PRO]
Medical - Medical: Instruments
Chinese term or phrase: dialysis machine
Hello,

I am translating a manual for a dialysis machine, and I wonder if there is a proper translation for dialysis machine.
It appears under the point 医疗器械生产企业许可证. So far I just found the translation "Lu Food and Drug Administration firearms production No. XXXXX" (http://zhidao.baidu.com/question/200588684.html), but it seems to be a machine translation.

Thank you for your help!
Egmont Schröder
Germany
Local time: 05:50
English translation:Manufacturing License Issued by Shandong Food & Drug Administration
Explanation:
鲁 = 山东省;食药监 = 食品药品监督管理局。It indicates the authority。械 = 器械 = device。生产许 = 生产许可。
It indicates the license to manufacture the dialysis machine.
According to 国家食品药品监督管理局,license is mandate to manufacture, distribute, and apply medical devices.
Below comes the link to China Food and Drug Administration website. It posts the Regulations for the Supervision and Administration of Medical Devices in both Chinese and English. The English there is not perfect. But it is the most authoritative and could be used to defend your translation in case you are challenged by the client.
Selected response from:

David Xing
Canada
Local time: 23:50
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Summary of answers provided
5Manufacturing License Issued by Shandong Food & Drug Administration
David Xing


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Answers


2 hrs   confidence: Answerer confidence 5/5
鲁食药监械生产许
Manufacturing License Issued by Shandong Food & Drug Administration


Explanation:
鲁 = 山东省;食药监 = 食品药品监督管理局。It indicates the authority。械 = 器械 = device。生产许 = 生产许可。
It indicates the license to manufacture the dialysis machine.
According to 国家食品药品监督管理局,license is mandate to manufacture, distribute, and apply medical devices.
Below comes the link to China Food and Drug Administration website. It posts the Regulations for the Supervision and Administration of Medical Devices in both Chinese and English. The English there is not perfect. But it is the most authoritative and could be used to defend your translation in case you are challenged by the client.

Example sentence(s):
  • Article 21 Medical device manufacturing enterprises shall not start manufacturing products before obtaining the manufacturing enterprise license.

    Reference: http://eng.sfda.gov.cn/WS03/CL0767/61641.html
David Xing
Canada
Local time: 23:50
Native speaker of: Native in ChineseChinese
PRO pts in category: 8
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