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    Home > Medical News > Latest Medical News > A number of major triple-A were investigated by 88 armed enterprises.

    A number of major triple-A were investigated by 88 armed enterprises.

    • Last Update: 2020-07-17
    • Source: Internet
    • Author: User
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    Pharmaceutical Network July 14th, Henan Provincial Drug Administration issued three on the second half of 2019 on the medical device inspection and rectification of the situation of the notice, involving operating enterprises, production enterprises, usersin the second half of 2019, in accordance with the Measures for Flight Inspection of Pharmaceutical Medical Devices, the Henan Provincial Drug Administration organized flight inspections of 41 medical device usersfor high-value medical supplies, sterile and implantation, in vitro diagnostic reagents, injectable sodium hyaluronic acid, custom denture teeth, color hyperbirth diagnostic instrument, perfluoropropane gas, baby incubator, ventilator and other key products, in accordance with the requirements of medical device use quality supervision and management measures, focus on inspectionthe problems and clues found in the inspection, the inspection team has handed over to the regulatory department of the medical device use unit for investigation and treatment in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices for the Monitoring and Reevaluation of Adverse Events of Medical Devices, the Measures for the Administration of Quality Supervision and Administration of the Use of Medical Devices, etc88 armed enterprises were investigated by the Henan Provincial Drug Administration pointed out that in the second half of 2019, according to the "Drug Medical Device Flight Inspection Measures", the inspection mainly related to sterile, in vitro diagnostic reagents, medical electrical, dental materials, patch category a total of 86 productsto develop inspection programs for enterprises with different product characteristics and types of risks, and to carry out a comprehensive inspection of the implementation of the quality and safety main responsibility, product quality and safety management of enterprises in accordance with the requirements of medical device manufacturing quality management norms and supporting regulatory documents, and to conduct a comprehensive inspection of key links such as procurement, production process, product inspection and product traceabilityinspection found that some enterprises are not skilled in medical device laws and regulations, risk management awareness needs to be further improved; What will theinspection department focus on? Recently, Ningxia Drug Administration issued "on the issuance of drug retail use, medical device business use and cosmetics business unit inspection guidelines notice", the notice published on-site inspection guidelines, worthy of reference and reference of various medical device enterprises, first self-examination.
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