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Efforts To Increase Circulation Of Illegal Business Regulation Of Medical Devices

Jul 11, 2016

On June 7, the State food and drug regulatory agency issued bulletin 2016 112th, decided on the circulation of illegal business concentration and control of medical devices. Announcement requirements all engaged in second class, and third class medical devices business enterprise on this enterprise June 1, 2014 yilai of medical devices business behavior whether exists 8 a aspects of illegal problem carried out self-examination, on exists of problem detailed description by with technique, and after, and involved medical devices and personnel, seriously developed rectification measures and plans, formed self-examination and rectification report, Yu July 15, 2016 Qian submitted location set district of city level food drug regulatory sector.

Office after the announcement, food and Drug Administration to act quickly in Hefei, official website to forward the announcement in this Council, and through medical device distributing Enterprise QQ Group enterprises. Hefei municipal Bureau will increase inspections of medical device business in the near future, without the required report, due to business, public list of priority targets; refusing to report, lied about concealing, or self-serious, corrective action in place, strictly investigated and dealt with, until revocation "medical license".

Hefei municipal Bureau of circulation, especially of medical devices class III medical device has been wholesale business as a regulatory focus, always keep the pressure situation. This year, 20 has been unilaterally changed the business premises or warehouse addresses violations of inspection department to handle the transfer of enterprises. And 26 to meet the business requirements of the enterprise applying for cancellation of "medical license".