Tongchuan Food and Drug Administration Centralized and Remedy Medical Device Illegal Business Behavior
According to the overall arrangement of the national bureau and the provincial bureau, since June 15, the Tongchuan Food and Drug Administration has carried out a three-month centralized rectification of illegal business operations in the field of medical device circulation. The content of this centralized rectification action is to standardize the order of medical device circulation, severely crack down on illegal business practices, conduct in-depth investigations of various risk hazards, and strengthen medical device supervision.
It is understood that this centralized rectification operation will take place from June 15 to September 15 for a period of three months. The centralized rectification will be carried out by means of self-inspection by the enterprise, inspection by the district/county bureau, and spot check and cross-check by the municipal bureau. Enterprises with low daily management level, chaotic purchase and sales channels, and frequent cases, and self-examination found that there are few problems and ineffective rectification measures; engaged in low-temperature, refrigerated medical device business enterprises and imported medical device domestic agents should be regarded as key inspections Object. It is required to select a number of varieties for each key inspection enterprise, and carry out upstream and downstream extension inspections of the flow direction and the authenticity of the bills. In case of problems found during the inspection, it is necessary to take decisive measures in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices and resolutely take measures to punish illegal enterprises. Whoever is suspected of committing a crime shall be handed over to the public security organ; if there is a serious violation of law or distrust of the medical device operating enterprise, joint punishment shall be implemented in accordance with relevant regulations.
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