On March 27th, the law enforcement officers of Tangshan City Food and Drug Administration conducted a raid on the behavior of decorative colored plain optical contact lenses without a license in Xinjie Street, and detained three companies with color flat invisible contact that were not sold by the “medical device operating enterprise licenseâ€. A total of 1313 glasses will be opened for investigation. The reporter saw that there were no logos on the bottles of these products, some were only in foreign languages, there was no Chinese logo, and the quality was not guaranteed. It is understood that with the launch of this action, the 5-month-long special campaign of "Five Remediation" for medical devices was formally launched by the Tangshan Food and Drug Administration. The action focused on rectifying false registrations, illegal production, and illegal operations. , exaggerated publicity, the use of unlicensed products, and other five violations of the law, at the same time announced the public hotline 12331.
In accordance with the relevant regulations, colored plain contact lenses have been incorporated into the supervision of the third category of medical devices. Failure to obtain such product medical device registration certificates and corresponding production and operation qualification certificates may not result in the production and operation of such products. The food and drug regulatory authorities reminded consumers that colored plain contact lenses, like contact lenses used to correct vision, are medical equipment products that are at higher risk. They must be worn by professionals before they are worn and follow strict procedures. Blind wear may occur. Cause adverse consequences.
It is understood that in this "five rectifications," Tangshan Food and Drug Administration will focus on rectifying the untrue behaviors of the first three applications for registration of medical devices. Focus on rectifying the use of custom dentures using raw materials that do not meet the standards and do not follow the standard factory inspections. The focus of remediation is to sell the second and third types of medical devices without authorization by an experience-based method, to operate unapproved decorative colored plain contact lenses and hearing aids, and not to store and transport in vitro diagnostic reagents as required. In rectifying the use of unlicensed products, it will focus on rectifying the behavior of unlicensed in vitro diagnostic reagents used by medical institutions. In rectifying and exaggerating propaganda behaviors, it focused on remediation of adherents and physiotherapy medical devices such as lumbar and leg pain, myopia, diabetes and high blood pressure for illegal propaganda, unauthorized advertising of unauthorized advertisements without approval or tampering with the contents of approval, exaggerating product efficacy and The scope of application; the use of medical research institutes or in the name of the experts, patients and images to prove the effectiveness of illegal advertising campaigns.
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