Injection of hyaluronic acid (sodium hyaluronate gel for scientific name injection) causes blindness in the eyes and injection of botulinum toxins to cause zombie face... In recent years, "micro-shaping" that has occurred in many places in the country has caused injury incidents, which has caused strong repercussions in society. The popularity of micro-shaping and the confusion of the medical cosmetic plastics market have caused many beauty seekers to be deceived by illegal cosmetic or plastic surgery institutions and accepted unidentified injections. "These illegal activities not only bring great harm to the health of consumers, but also seriously affect the order of supervision of drugs. The State Food and Drug Administration has attached great importance to this. In recent years, it has organized food and drug regulatory authorities at all levels to increase propaganda. At the same time, the public security department vigorously carried out special rectification and investigated and handled a number of major cases, which strongly shocked the illegal activities of illegally producing, selling and using micro-plastic medicines, minimizing social harm and ensuring the safety of medical equipment for public use. The relevant person in charge of the bureau told reporters.

Regulatory initiatives

Heavy punching micro-plastic fake medicine

The reporter learned that since 2014, there have been new breakthroughs in the number of cases and investigations of illegal micro-plastic medicine cases in China. A group of latest data provided by the General Administration Inspection Bureau showed that in 2014 and 2015, the food and drug supervision departments at all levels in the country jointly investigated and handled a number of major cases of illegal micro-plastic medicines, and smashed dozens of fake and fake sales dens. There were 181 suspects involved, involving a total amount of 240 million yuan. Since 2016, the General Administration has organized national food and drug supervision departments to carry out special actions, and investigated and dealt with more than 50 cases of suspected illegal production, sale and use of botulinum toxins, and transferred them to 31 public security organs, smashing 4 fake dens and selling fake dens 22 The relevant cases are still under investigation. Judging from the number of cases in various places, the number of cases in coastal provinces is relatively large, accounting for more than 60% of the total number of such cases.

揭秘“微整形”背后的假药械黑幕

In response to social concerns, the General Administration issued an authoritative voice in a timely manner to guide local governments to increase the supervision of micro-plastic medicines and to remind consumers to choose legal and regular products and services.

In micro-plastic appliances, sodium hyaluronate gel for injection is a third-class medical device with high risk. In response to the problems of individual illegal traders, beauty salons, and the use of fake injection-filled sodium hyaluronate gel products to pose potential safety hazards to consumers, the General Administration of the People’s Republic of China issued the Consumer Alert on the use of sodium hyaluronate for injection in May 2015. ", remind consumers that the production and operation of sodium hyaluronate for injection must obtain the "Medical Device Registration Certificate", "Medical Device Production License" and "Medical Device Business License". Medical beauty agencies should purchase qualified products from companies that have obtained legal qualifications when purchasing such products. Consumers should go to the formal medical institutions or medical beauty agencies that have obtained the "Certificate of Medical Institutions" for injection beauty and find out the true condition of the products.

At the beginning of 2016, according to the health and family planning department, some hospitals in Beijing, Shanghai, Zhejiang, Guangdong and other provinces (autonomous regions and municipalities) successively admitted a group of patients who were urgently treated for injection of unidentified substances in non-medical institutions. Before entering the hospital, these patients had injected "botulinum toxin" in non-medical institutions for cosmetic needs such as face-lifting and stovepipe. In June 2016, the General Administration of the People’s Republic of China issued the “Consumption Warning on Botulinum Toxin Type A for Injection” to remind consumers that improper use of botulinum toxin type A for injection may cause muscle relaxation and paralysis. In severe cases, it may cause respiratory failure and heart failure. And other life-threatening symptoms. Consumers should go to the formal medical institutions or medical beauty agencies that have obtained the "Certificate of Medical Institutions" for injection beauty. When using, pay attention to distinguish whether it is a regular product. At the same time, the General Administration of the People's Republic of China informed the China Hair and Beauty Association and the All-China Federation of Industry and Commerce of the Beauty and Cosmetics Industry Association about the incidents of non-medical institutions injecting suspected "botulinum toxin" products, interpreting the regulatory requirements of the botulinum toxins of the General Administration, and urging the two Industry associations strengthen the self-discipline management of the industry and require member companies to implement the main responsibility. In July 2016, the General Administration of the People's Republic of China issued the "Notice on Strengthening the Management of Botulinum Toxin Type A for Injection", emphasizing that the national food and drug supervision department will effectively strengthen the production and operation supervision of botulinum toxin type A for injection, and urge enterprises to strictly follow the medical treatment. "Administrative Measures on Toxic Drugs", "Notice on the inclusion of botulinum toxin type A in the management of toxic drugs", consciously operate and operate according to laws and regulations, prevent such products from flowing into illegal beauty institutions from legal channels, and prevent counterfeit drugs from entering legal channels.

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