Changsha city has fully promoted the implementation of the "strict quality management code for the quality of medical devices". Today, the reporter learns from changsha food drug administration, October 1, the city will conduct site inspection of medical device manufacturing enterprise acceptance, unqualified companies "HeiBang" directly related business activities. In the future, a fine of up to 20 times the value of the goods may be made without permission.
According to the changsha food drug administration issued by the full implementation of medical equipment production and the quality control standard of changsha work plan "hereinafter referred to as" rules, in the daily supervision and inspection, as long as found that do not conform to the requirements of general projects, shall order the enterprise rectification within a time limit; If the key project does not meet the requirements or even if the general project does not meet the requirements but will have a direct effect on the quality of the product, the enterprise must suspend production and rectification; If the circumstances are serious, the production license may be revoked.
Changsha food food and drug administration said that as the medical equipment production and the quality control standard for the full implementation of, the future of medical device manufacturing enterprise in the legal level increased the penalties. A fine of up to 20 times the maximum value of the value of a medical instrument that is not permitted without permission and "suspended" for five years; If the inspection institution issues a false report, it shall revoke the qualification of the institution and "suspend the suspension" for 10 years; The persons who are directly responsible for the punishment shall not be engaged in the inspection of medical devices within 10 years.
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A case in the field of medical hygiene
Will be included in the credit system
National health and family planning commission is 12 "on strengthening the construction of health family planning system enhancement of opinions held a regular news briefing, said to continue to promote the construction of medical ethics, health, family planning system will be woven knit on enhancement of the high voltage network construction, carry out special focus areas, at the same time to build a credit system, pharmaceutical sales field and medical treatment service institutions and individuals rampant cases included in the credit reporting system, system of country's industry.
According to national health development planning commission, 2014, our country put forward to strengthen the construction of medical and health enhancement of "nine" is not allowed, including no personal income to medical and drug and medical check earnings, are not allowed to order commission, etc. The national health and family planning commission has conducted 880 special administrative activities in 14 provinces and cities since the regulation was introduced. |