Contact Lens Yantai City Food and Drug Administration held a five-month “Five Rectification†medical device special action to start this month. The action will focus on rectifying the five types of illegal acts such as false registration declaration, illegal production, illegal operation, exaggeration of publicity, use of unlicensed products, etc., in order to effectively solve the problems involving the vital interests of the people through a combination of unannounced visits, centralized investigations, and surprise inspections. problem.
According to the special action plan, the food and drug supervision department of the city will focus on rectifying the untrue behavior of the first registration applications for the second and third categories of medical devices; the use of infusion devices and single-use catheters (bags) for non-compliance Production of raw materials and sterilization not required, condoms not authorized for production without authorization, and hemodialysis concentrates are not subject to standard factory inspections; remediation sells second and third types of medical devices without experience by experience, without evidence Manufacture of decorative flat plain contact lenses and hearing aids, failure to store and transport in vitro diagnostic reagents, etc.; Remedies such illegal applications as lumbar and leg pain, myopia, diabetes, high blood pressure and other types of affixing, physiotherapy medical devices, etc., and use of medical research Institutes or advertising and propaganda in the name and image of experts, patients, etc.; Remediation of the use of undocumented in vitro diagnostic reagents by medical institutions.
All violations of laws and regulations discovered in this special action shall be handled promptly, strictly, and severely, and shall be punished according to the upper limits prescribed by laws and regulations; in serious cases, licenses for production and business operators and products shall be revoked; all those suspected of committing crimes shall be punished. The public security organs shall be investigated for criminal responsibility in accordance with the law; products that have potential safety hazards shall be ceased from sale and use, and enterprises shall be ordered to recall and supervise their destruction.
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