Crack down on illegal medical beauty! The State Food and Drug Administration reported to investigate and deal with 6 typical illegal cases
2021-11-19
According to the official website of the State Food and drug administration, the State Food and Drug Administration recently reported to investigate and deal with six typical cases of illegal medical devices that can be used for medical beauty, involving Nanjing furuosi Medical Beauty Clinic Co., Ltd., Guangzhou dawn Beauty Instrument Co., Ltd., Guangzhou Ruimei Medical Beauty Clinic Co., Ltd., Meishan Yuemei Medical Beauty Co., Ltd Panzhihua just in time medical beauty clinic Co., Ltd. and Shanghai ruilaili Medical Beauty Clinic Co., Ltd. The State Food and Drug Administration said that according to the special rectification plan for combating illegal medical and beauty services jointly issued by the State Health Commission, the central network information office, the Ministry of public security, the General Administration of customs, the General Administration of market supervision, the State Post Office, the State Food and drug administration and the State Administration of traditional Chinese medicine, and Notice of the comprehensive Department of the State Food and Drug Administration on Further Strengthening the supervision of medical devices that can be used for medical beauty It is required that the drug regulatory authorities strengthen the supervision and inspection of medical device production and trading enterprises and medical institutions according to their duties, and investigate and deal with medical devices that do not meet the statutory requirements according to law. The State Food and drug administration actively organizes local drug regulatory authorities to carry out special rectification work against illegal medical beauty services. All localities strengthen supervision and law enforcement, and severely crack down on medical devices that can be used for medical beauty Violations of laws and regulations, investigated and dealt with a number of violations of laws and regulations, and effectively safeguarded the legitimate rights and interests of patients. Typical cases are as follows: 1、 Nanjing Qinhuai District market supervision and administration bureau investigated and dealt with the case of Nanjing furuosi Medical Beauty Clinic Co., Ltd. using class III medical devices that were not registered according to law On January 18, 2021, during the on-site inspection of Nanjing furuosi Medical Beauty Clinic Co., Ltd., the law enforcement personnel of Nanjing Qinhuai District market supervision and Administration Bureau found that there were relevant products without Chinese marks in the party's business premises. After investigation, the products purchased and used by the party should be managed in accordance with class III medical devices. According to the regulations on the supervision and administration of medical devices (revised in 2017) Article 66 stipulates that administrative penalties shall be imposed on the parties: 1. Order them to stop the illegal act immediately; 2. Confiscate the products involved; 3. Fine 98880 yuan. 2、 Guangzhou Baiyun District market supervision and administration bureau investigated and dealt with the case of Guangzhou dawn Beauty Instrument Co., Ltd. operating class II and class III medical devices without medical device registration certificate On April 15, 2021, during the on-site inspection of Guangzhou dawn Beauty Instrument Co., Ltd., the law enforcement personnel of Guangzhou Baiyun District market supervision and Administration Bureau found that the parties had placed 3 related products in the business premises that were not marked with product name, medical device product registration certificate, manufacturer and other information. After investigation, according to the structural composition, expected use and working principle of the products involved , two of the products involved in the case shall be managed according to class II medical devices and one shall be managed according to class III medical devices. During the period from January 18, 2021 to April 15, 2021, the party involved engaged in the operation of class II and class III medical devices without medical device registration certificate, and the total value of the products involved in the case was 22100 yuan, with a total illegal income of 11900 yuan. According to Regulations on the supervision and administration of medical devices (revised in 2017) Article 63 and other provisions impose administrative penalties on the parties: 1. Confiscate the parties' illegal income of 11900 yuan; 2. Confiscate the parties' illegal medical device products; 3. Impose a fine of 298350 yuan for the parties' operation of class II and class III medical devices without medical device registration certificate; 4. Order the parties to correct the behavior of changing the business place and warehouse address without authorization, and For this behavior, a fine of 16000 yuan shall be imposed; 5. The party concerned shall be ordered to correct the behavior of purchasing medical devices from unqualified individuals, and a fine of 16000 yuan shall be imposed for this behavior. 3、 Guangzhou Baiyun District market supervision and administration bureau investigated and dealt with the case of Guangzhou Ruimei Medical Beauty Clinic Co., Ltd. using class III medical devices without medical device registration certificate On March 10, 2021, during the on-site inspection of Guangzhou Ruimei Medical Beauty Clinic Co., Ltd., the law enforcement personnel of Guangzhou Baiyun District market supervision and Administration Bureau found that the parties concerned stored relevant products without Chinese marks in the business premises. After investigation, according to the structural composition, intended use and working principle of the products involved, the products involved should be managed according to class III medical devices The party involved used class III medical devices that were not registered according to law, and the total value of the products involved was 11900 yuan. According to paragraph 1 (3) of Article 66 and paragraph 2 of Article 68 of the regulations on the supervision and administration of medical devices (revised in 2017) Administrative penalties shall be imposed on the parties in accordance with the provisions of item: 1. Order the parties to correct their behavior of failing to establish and implement the medical device purchase inspection record system and give a warning; 2. Order the parties to correct their behavior of using medical devices that are not registered according to law; 3. Confiscate the medical devices illegally used by the parties; 4. Impose a fine of 89250 yuan. 4、 Meishan market supervision and administration bureau investigated and dealt with the case of Meishan Yuemei Medical Beauty Co., Ltd. using unregistered medical devices On March 16, 2021, during the on-site inspection of Meishan Yuemei Medical Beauty Co., Ltd., the law enforcement personnel of Meishan market supervision and Administration Bureau found that the parties involved used relevant products without product information marked in the business premises. After investigation, the products involved were unregistered medical devices, and the parties acted on two of them on the human body, which constituted the use of unregistered products The total value of the products involved in the illegal act of medical devices is 11900 yuan. According to paragraph 1 of Article 66 of the regulations on the supervision and administration of medical devices (revised in 2017), the parties shall be subject to administrative punishment: 1. Confiscate the illegally used medical devices; 2. Fine 95700 yuan. 5、 Panzhihua market supervision and administration bureau investigated and dealt with the case of using unregistered imported medical devices by Panzhihua zhengcha Medical Beauty Clinic Co., Ltd On January 15, 2020, the law enforcement officers of Panzhihua market supervision and Administration Bureau found products without Chinese marks in the business premises of the parties during the on-site inspection of Panzhihua Zhengzheng Medical Beauty Clinic Co., Ltd. after investigation, it was determined that the products involved were unregistered medical instruments. Panzhihua Zhengzheng Medical Beauty Clinic Co., Ltd. used imported medical instruments that were not registered according to law The total value of the products involved in the act of medical devices is 46780 yuan. According to the provisions of Article 66, paragraph 1 (3), Article 68, paragraph 1 (2) and other regulations of the regulations on the supervision and administration of medical devices (revised in 2017), the parties are subject to administrative penalties: 1. Warning; 2. Confiscating the illegally used medical devices; 3. Confiscating the illegal income of 40448 yuan; 4. Fine 191345 yuan. 6、 Shanghai Fengxian District market supervision and administration bureau investigated and dealt with the case of using unregistered medical devices by Shanghai ruilaili Medical Beauty Clinic Co., Ltd On October 12, 2020, when the law enforcement personnel of Shanghai Fengxian District market supervision and administration conducted an on-site inspection on Shanghai ruilaili Medical Beauty Clinic Co., Ltd., the party concerned failed to provide the qualification materials of relevant products. After investigation, the products involved have not obtained the medical device registration certificate. Shanghai ruilaili medical Beauty Clinic Co., Ltd. has the practice of using unregistered medical devices As a result, the total value of the products involved in the case was 76600 yuan. According to item (3) of Article 66 of the regulations on the supervision and administration of medical devices (revised in 2017), the parties were subject to administrative penalties: 1. Confiscate the illegally used medical devices; 2. Impose a fine of 498000 yuan. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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