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- The state make further strengthens of the inspection of medical device industry
The state make further strengthens of the inspection of medical device industry
In order to strengthen the quality
supervision and management of medical equipment, to ensure the safety of
medical equipment products use effectively, the state food and drug
administration has asked enterprises to local food and drug supervision and administration
authority in accordance with the regulations on the supervision and
administration of medical devices and the food and drug supervision bureau
general office work on further strengthening medical equipment of proper notice
medical apparatus and instruments
Relevant dealing with medical device
manufacturing enterprise does not conform to the stipulations of the standard
products, does not conform to the stipulations of the standard project risk
assessment, according to the severity of the medical equipment defect level of
recall, is voluntarily recalling and public recall information. The food and
drug administration department in the place where the enterprise is located
shall supervise the recall of enterprises, and the recalled shall be ordered to
be recalled. Provided is not in conformity with the standards of medical
equipment products cause harm to human body or there is evidence that may
endanger human body health, should be taken to suspend the production, import,
management, use of emergency control measures. The relevant provincial food and
drug supervision and administration departments should urge enterprises to find
out the reasons as soon as possible, formulate rectification measures and fix
them in place on time.
With regard to the national demand for
medical devices, the relevant units must be taken seriously,Guangzhou Xiangli
Instrument Co., LTD. is an
expert in packaging materials testing instruments, and has cooperated with many
well-known medical devices and equipments in