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[industry information] the implementation of the
Source:This station Release date:2017-9-14 Number of clicks:719

The simulation of driver's license deduction system will reduce the failure of medical device enterprises to a certain extent until it is eliminated. The idea issued by Sichuan province is a pioneering work.



In October 13th, the provincial food and Drug Administration announced on the classification of supervision and management of the implementation of Sichuan Province, the introduction of new medical equipment enterprises "(hereinafter referred to as the" opinions "provisions"), starting from December 1st this year, our province medical equipment enterprises in the implementation of the classification regulation, the implementation of the illegal production of medical equipment enterprise management system, points system to the regulations on the credit risk of high production enterprises to strict control and law-abiding integrity of corporate incentives, through the implementation of regulatory measures to maintain pressure, improve the supervision and management of medical equipment enterprises scientific level and efficiency of supervision.
"Opinions" put forward, our province medical equipment production enterprises will take four levels of supervision, medical equipment business enterprises will take three levels of supervision. "Opinions" requirements, food and drug supervision and management departments at all levels across the province for medical equipment enterprises in accordance with the supervision level of the integrated use of all project inspection, flight inspection, daily inspection, tracking and inspection, special inspection and supervision and inspection and other forms of supervision and management.
The "opinion" stipulates that the medical equipment production enterprises in our province will carry out the score management of illegal behavior. Points for the period of a year, the production enterprises in accordance with the different level of supervision in the annual record on different basic score, four level of supervision of enterprises 9, three level of supervision of enterprises 6, two level of supervision of enterprises 3, a level of supervision enterprises is 0 points.
To apply for license or registration provides false information and other illegal acts will be a record 9 points, the forged or altered, the sale, lease or loan related medical licenses and other illegal acts a record 6 points, the production specification, the label does not comply with the provisions of the medical equipment and other illegal acts a record 3 points.
Within one year of scoring more than 20 points of the enterprises, regulatory authorities will take measures such as exposure, interviews, urge its rectification; if there is illegal behavior were investigated in the year, it is necessary to apply the heavier punishment, enterprise may be fined, ordered to stop or limit the revocation of the production license and other penalties. If there is no record of illegal behavior for more than 3 years, it will be rewarded with notification, recognition and exempt from daily check.

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