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Sungene biotech gains Medical device manufacturing enterprise license



For the sake of development needs and overall strategic planning, Sungene biotech Co., Ltd successfully applied for People's Republic of China medical equipment manufacturing enterprise license. License Number: 津食药监械生产许20120373号. It is valid until November 28, 2017.

Medical Device Manufacturing Enterprise License is a necessary prerequisite for enterprise to apply for system assessment and product registration. In order to enable enterprises to produce as soon as possible, our company did lot of extensive preparations for the application.

In the beginning of September, our company submit an application, some related personnel in Food and Drug Administration coordinated related affairs many times for our company, instructed enterprise to prepare documents, gave guidance for the problems existed in establishment, our company made timely correction, which enables enterprise to shorten the application time; Finally, we passed the review and on-site inspection and inspection of application documents successfully. In November, inspection team carried out on-site inspection and checking. By the examination of company personnel qualifications, facilities, regulations and quality control documents, production capacity, testing capacity and other aspects of scrutiny, inspection team agreed that our company was in full compliance with Medical Device Manufacturing Enterprise License on-site review standards , and pass the inspection, issue a manufacturing license in the shortest time.

The issued medical equipment manufacturing enterprise licence of Sungene Biotech Co., Ltd meant that our company's antibody reagents gradually enter into the clinical market.



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