Many people regard contact lenses as ordinary living articles. Actually, contact lenses, care solutions, and prosthetic heart valves belong to the highest-level medical devices. Operating companies must obtain medical device operating enterprise licenses before they can sell. Yesterday, the city's food and drug administration department held a mobilization meeting to deploy the "Five Remediation" special action for medical devices.
This special action of medical device "Five Remediation" started from April 10 to mid-August, focusing on five kinds of behaviors such as false registration of medical devices, illegal production, illegal operation, exaggeration of publicity, and use of unlicensed products.
In recent years, the medical device industry in our city has developed rapidly. However, the overall size of the industry is relatively small. Some companies' violations of laws and regulations occur from time to time, and there are hidden dangers in the quality and safety of some products. This special action mainly focused on five aspects: First, it was to rectify the false declaration of registration, and it focused on rectifying the untrue behaviors of the first and third applications of medical devices for the first time. The second is to rectify illegal production practices, focus on rectifying unqualified raw materials production, key processes failing to be verified according to regulations, or failing to produce according to technical regulations, commissioning production without authorization, and releasing products without factory inspection according to registered product standards. The third is to rectify illegal business practices, and focus on remediation of the sale of second and third types of medical devices without permission by an experiential method, uncertified sales or fitting of corneal contact lenses, orthokeratology lenses, hearing aids, and other fitting medical devices. Store and transport in vitro diagnostic reagents as required. Fourth, rectifying and exaggerating propaganda behavior, focusing on remediation of medical equipment for personal consumption such as patching and physiotherapy, and arbitrarily issuing illegal advertising without approval or falsification of the contents of the examination; using medical research institutes or certificates of efficacy and the names of experts, patients, etc. Carry out illegal advertising; illegally exaggerate the effectiveness of products and the scope of application. The fifth is to rectify the use of unlicensed products, focusing on rectifying the behavior of medical institutions using undocumented in vitro diagnostic reagents.
The action focused on key products, enterprises, and case clues. According to the work model of combining inspection, rectification, and standardization, the inspection methods of unannounced visits, centralized inspections, and surprise inspections were combined. All violations of laws and regulations were found to be quick and easy. Strictly and heavily dealt with, and impose penalties according to laws and regulations; if the circumstances are serious, all licenses for production and business operators and products shall be revoked; all suspected criminals shall be transferred to public security agencies for investigation of criminal liability according to law; for products with potential safety hazards, All sales and use shall cease, and enterprises shall be ordered to recall and supervise destruction.
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