Many medical institutions use illegal medical equipment! Fda exposes typical cases

On the 24th, the State Food and Drug Administration reported seven typical cases of illegal medical devices that can be used for medical beauty. In accordance with the National Health Commission, the Central Cyberspace Administration of China, the Ministry of Public Security, the General Administration of Customs, the General Administration of Market Regulation, the State Post Bureau, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine and other eight departments jointly issued the "Combat illegal medical beauty services special rectification work program" and "the State Food and Drug Administration on further strengthening the supervision of medical devices that can be used for medical beauty Notice", Drug regulatory departments shall, in accordance with their duties, strengthen the supervision and inspection of medical device production and distribution enterprises and medical institutions, and investigate and punish medical devices that do not meet legal requirements according to law.

Since the beginning of this year, the State Food and Drug Administration has actively organized drug regulatory departments around the country to carry out special rectification work against illegal medical beauty services. All localities have increased supervision and law enforcement efforts, severely cracked down on violations of laws and regulations that can be used for medical cosmetic medical devices, investigated and dealt with a number of illegal cases, and effectively safeguarded the legitimate rights and interests of patients.

1. Market Supervision Administration of Chaoyang District, Changchun City, Jilin Province investigated Sansheng Lanmeng Medical Beauty outpatient Department for the use of unregistered medical devices

On May 10, 2021, the Market Supervision and Administration Bureau of Chaoyang District of Changchun City found that the relevant products used by the parties had no Chinese logo and could not provide a registration certificate during the on-site inspection of Sansheng Lanmeng Medical beauty outpatient Department. After investigation, according to the structural composition and intended use of the products involved, the products involved were medical devices that were not registered according to law, and the value of the goods totaled 66,050 yuan. According to Article 66 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the following administrative penalties are imposed on the parties :1. Warning; 2. Confiscation of illegal medical devices; 3. A fine of 330,250 yuan.

Second, Daqing City Market Supervision and Administration Bureau of Heilongjiang Province investigated the case of Daqing Chaolong Medical Beauty Clinic Co., Ltd. using unregistered medical devices

On August 5, 2021, law enforcement personnel of Daqing Market Supervision Administration inspected Daqing Chaolong Medical Beauty Clinic Co., LTD., and found that 270 sterile injection needles without Chinese marks were stored in the business premises of the parties. After investigation, the value of the medical devices involved in the case was 110 yuan, and the parties had illegal acts of using medical devices that were not registered according to law. According to the provisions of Article 86, paragraph 1 (3) of the Regulations on the Supervision and Administration of Medical Devices, the following administrative penalties are imposed on the parties: 1. Confiscation of medical devices involved; 2. A fine of 25,000 yuan.

Iii. Shangcheng District Market Supervision Administration of Hangzhou City, Zhejiang Province investigated the case of third class medical devices operated by Bizheng Medical Technology (Zhejiang) Co., Ltd. without registration certificate

On June 8, 2021, law enforcement personnel of Shangcheng District Market Supervision and Administration Bureau in Hangzhou, Zhejiang Province received a telephone lead, reflecting that the outer packaging of hyaluronic acid for injection sold to a beauty hospital by Bisheng Pharmaceutical Technology (Zhejiang) Co., Ltd. under the jurisdiction had no Chinese logo. On June 10, 2021, law enforcement officers conducted an on-site inspection of the company and seized 9 boxes of injection hyaluronic acid products on the spot, marking the production date in October 2019. The "Medical Device Registration Certificate" presented by the company on the spot showed that the time for the first registration was November 1, 2019. Therefore, the above products are not produced within the validity period of the Medical Device Registration Certificate, and are the third type of medical devices that have not obtained the medical device registration certificate. After investigation, the party has sold 11 boxes to a beauty hospital. According to the provisions of Article 63, paragraph 1 (1) of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the following administrative penalties are imposed on the parties: 1. Confiscation of medical devices involved; 2. Confiscated illegal gains of 46,371.68 yuan; 3. A fine of 109,6058.21 yuan.

Fourth, Shandong Linyi City Market Supervision Administration investigated the case of Linyi Zhongyan Medical Beauty Clinic Co., Ltd. using unregistered medical devices

On September 16, 2021, the Linyi Market Supervision and Administration Bureau conducted an on-site inspection of Linyi Zhongyan Medical Beauty Outpatient Department Co., LTD., and found that 2 sets of related products without product registration information were stored in the business premises of the parties. After investigation, according to the structural composition, intended use, and working principle of the products involved, the above two devices should be managed in accordance with the second category of medical devices, with a total value of 5,000 yuan. According to the provisions of Article 86, paragraph 1 (3) of the Regulations on the Supervision and Administration of Medical Devices, the following administrative penalties are imposed on the parties: 1. Warning; 2. Confiscation of medical equipment involved in the case; 3. A fine of 29,000 yuan.

V. Market Supervision Administration of Dengzhou City, Henan Province investigated the case of Meiren International beauty Salon using unregistered medical devices

On November 8, 2021, law enforcement personnel of the Market Supervision Administration of Dengzhou City, Henan Province, conducted an on-site inspection of Meiren International Beauty Salon and seized 12 boxes of injected hyaluronic acid products without Chinese logo. After investigation, the above products should be managed in accordance with the third class of medical devices, the value of the amount of 9,800 yuan, and the illegal income of 1,400 yuan. According to the provisions of Article 86, paragraph 1 (3) of the Regulations on the Supervision and Administration of Medical Devices, the following administrative penalties are imposed on the parties: 1. Confiscation of medical devices involved; 2. Confiscation of illegal gains of 1,400 yuan; 3. A fine of 50,000 yuan.

Vi. Market Supervision Administration of Zhuhai City, Guangdong Province investigated the case of Zhuhai Xinyan Medical Beauty Clinic Co., LTD. 's use of unregistered medical devices

On April 30, 2021, law enforcement personnel of the Market Supervision Administration of Zhuhai City, Guangdong Province conducted an on-site inspection of Zhuhai Xinyan Medical Beauty Outpatient Department Co., LTD., according to law, and found that 81 injection needles without Chinese logos were stored in the premises of the parties concerned. After investigation, the products involved should be managed in accordance with the third class of medical devices, the value of the amount is 405 yuan, and the parties have illegal acts of using medical devices that are not registered according to law. According to the provisions of Article 66 (3) and Article 68 (2) of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), administrative penalties are imposed on the parties: 1. Warning; 2. Confiscation of medical equipment involved in the case; 3. A fine of 35,000 yuan.

7. Huaxi District Market Supervision Administration of Guiyang City, Guizhou Province investigated the case of Guiyang Huaxi Medical Beauty Co., Ltd. using unregistered medical devices

On January 29, 2021, when Huaxi District Market Supervision Administration inspected Guiyang Huaxi Medical Beauty Co., LTD., it was found that the company's pharmacy displayed 2 boxes of sodium hyaluronic acid products with or without Chinese logo, and the company failed to provide product registration certificate, purchase ticket, supplier qualification, acceptance record, use record and other materials. After investigation, the products involved should be managed in accordance with the third class of medical devices, and the value of the goods is 2000 yuan. In accordance with Articles 66 and 68 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), administrative penalties are imposed on the parties: 1. Warning; 2. Confiscation of medical equipment involved in the case; 3. A fine of 20,000 yuan.