News: Hefei intensifies efforts to rectify illegal business operations in the field of medical device circulation

On June 7, the State Food and Drug Administration issued the No. 112 Announcement of 2016, which decided to carry out centralized rectification of illegal business operations in the field of medical device circulation. The announcement requires all medical equipment operating enterprises engaged in the second and third categories to conduct self-examination on the illegality of the medical device business operations since June 1, 2014, and to describe the existing problems in detail. After the medical equipment and personnel involved, the rectification measures and plans were carefully formulated to form a self-examination and rectification report, which will be submitted to the municipal food and drug supervision department in the local district before July 15, 2016.

After the announcement of the General Administration of the People's Republic of China, the Hefei Food and Drug Administration has acted swiftly, forwarded the announcement of the General Administration on the official website of the Bureau, and informed the enterprise through the QQ group of medical device management enterprises. The Hefei Municipal Bureau will intensify the inspection of medical device management enterprises in the near future, and list the enterprises that have not reported according to the requirements to the public, and list them as the key inspection targets; refuse to report, report false reports and self-inspection. Seriously, rectification is not in place, from strict re-examination, until the revocation of "medical device business license."

The Hefei Municipal Bureau has always regarded the medical device circulation field, especially the third category of medical device wholesale enterprises, as the focus of supervision, and has always maintained a high pressure. Since the beginning of this year, 20 companies that have illegally changed their business premises or warehouse addresses have been handed over to the inspection department for handling. And 26 enterprises that are difficult to meet the requirements of business regulations apply for cancellation of the “Medical Device Business License”.

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