Further strengthen the market supervision of the medical device circulation in the city, focus on rectifying the outstanding problems in the circulation of medical devices, and severely crack down on violations of laws and regulations. From June 20 to the end of September, the food and drug supervision department of the city will illegally operate the medical device circulation field. The behavior is concentrated and rectified.
Recently, the Yan'an Food and Drug Administration held a special meeting to conduct a centralized interview with the person in charge of the relevant medical device management enterprises in the city, clearly inform the work content and key points of this rectification, and sign the integrity business commitment with the responsible persons of the enterprises. The book consolidates the corporate responsibility.
It is reported that in accordance with the unified arrangements of the city, this centralized rectification will cover all the second- and third-class medical device operating enterprises in the city, focusing on rectifying the operating enterprises engaged in medical device wholesale business to unqualified operating enterprises or users; The operating conditions have changed, no longer meet the requirements of the medical device management quality management norms; the medical device instructions that have not been rectified and operated according to the regulations; the labels do not comply with the relevant regulations; the medical devices are not transported and stored in accordance with the medical device instructions and labeling requirements. 8 illegal business activities.
The centralized rectification work is divided into four stages: arrangement and deployment, enterprise self-examination, centralized rectification, and summarization and improvement. At present, it has entered the enterprise self-examination stage. All the second- and third-class medical device operating enterprises in the city are conducting self-examination of the eight key work items of the centralized rectification according to the requirements of the medical device operation behavior since June 1, 2014, and found out for self-examination. The problem, carefully formulate rectification measures and plans, and form a self-examination and rectification report. The food and drug supervision department will have many problems such as low daily management level, chaotic purchase and sales channels, and multiple cases, and the companies that have found fewer problems, lack of rectification measures, and those engaged in low-temperature and refrigerated medical device business are listed as key inspection targets.
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