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The State Food and Drug Administration notified and investigated typical cases that can be used for medical aesthetics and medical device violations

The State Food and Drug Administration notified and investigated typical cases that can be used for medical aesthetics and medical device violations

  • Time of issue:2021-12-15
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The State Food and Drug Administration notified and investigated typical cases that can be used for medical aesthetics and medical device violations

  According to the "Special Rectification Work Plan for Combating Illegal Medical Beauty Services" jointly issued by 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 Supervision, the State Post Bureau, the State Drug Administration, and the State Administration of Traditional Chinese Medicine. ”And the “Notice of the Comprehensive Department of the State Drug Administration on Further Strengthening the Supervision of Medical Devices that Can be Used for Medical Aesthetics” requires that the drug regulatory department strengthens the supervision and inspection of medical device manufacturers and medical institutions in accordance with their duties, and investigates and deals with non-compliance with statutory requirements in accordance with the law Medical equipment. The State Food and Drug Administration actively organizes local drug regulatory agencies to carry out special rectification work against illegal medical beauty services. Localities have increased their supervision and law enforcement, severely cracked down on illegal activities that can be used for medical beauty and medical devices, and investigated and dealt with a number of cases of violations of laws and regulations, effectively safeguarding the legitimate rights and interests of patients.

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  Case 1:

  Guangzhou Baiyun District Market Supervision and Administration Bureau investigated and dealt with cases of Class II and Class III medical devices for which Guangzhou Doen Beauty Instrument Co., Ltd. did not obtain a medical device registration certificate

  On April 15, 2021, during an on-site inspection of Guangzhou Doen Beauty Apparatus Co., Ltd., law enforcement officers of the Baiyun District Market Supervision and Administration Bureau of Guangzhou found that the parties had placed unmarked product names, medical device product registration certificates, 3 sets of products related to information such as production companies.

  After investigation, according to the structure, expected use, working principle, etc. of the products involved, two of the products involved should be managed in accordance with the second category of medical devices, and one should be managed in accordance with the third category of medical devices. During the period from January 18, 2021 to April 15, 2021, the parties involved in the operation of the second and third types of medical devices that have not obtained the medical device registration certificate. The total value of the involved products is 22,100 yuan, and the total illegal income is 11900 yuan.

  Administrative penalties were imposed on the parties in accordance with Article 63 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017) and other provisions: 1. Confiscate the party’s illegal income of RMB 11,900; 2. Confiscate the party’s illegally operated medical device products; 3. Right The party involved in the operation of the second and third category medical devices that have not obtained the medical device registration certificate shall be fined 298,350 yuan; 4. Order the party to correct the behavior of changing the business premises and warehouse address without authorization, and impose a fine of 16,000 yuan on the behavior; 5 . Order the parties to correct the behavior of purchasing medical devices from unqualified individuals and impose a fine of 16,000 yuan for the behavior.

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