According to the National Health Commission Central network information office Ministry of public security customs head office General Administration of market supervision State Post Bureau State Food and Drug Administration Jointly issued by the State Administration of traditional Chinese medicine and other eight departments Special rectification work plan for combating illegal medical and beauty services as well as Circular 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 requirement,The drug regulatory department shall strengthen the supervision and inspection of medical device manufacturing and trading enterprises and medical institutions according to their duties,Investigate and deal with medical devices that do not meet legal requirements according to law.The State Food and drug administration has actively organized local drug regulatory departments to carry out special rectification against illegal medical beauty services.All localities have strengthened supervision and law enforcement,Severely crack down on violations of medical devices that can be used for medical beauty,A number of illegal cases were investigated and dealt with,Effectively safeguard the legitimate rights and interests of patients.

Typical cases are as follows

one 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

2021year1month18day,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,It is found that relevant products without Chinese logo are stored in the business premises of the parties.After investigation,The products purchased and used by the parties shall be managed in accordance with class III medical devices.basis Regulations on the supervision and administration of medical devices 2017Revised in Article 66,Impose administrative penalties on the parties

1.Order to stop the illegal act immediately

2.Confiscation of products involved

3.fine98880element.

two Guangzhou Baiyun District market supervision and administration bureau investigated and dealt with the second category of Guangzhou dawn Beauty Instrument Co., Ltd. that did not obtain the medical device registration certificate Class III medical device case

2021year4month15day,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,It is found that the product name is not marked on the place of business Medical device product registration certificate Production enterprises and other information related products3platform.After investigation,According to the structure of the product involved Intended use Working principle, etc,Among the products involved2The desk shall be managed in accordance with class II medical devices,1The desk shall be managed in accordance with class III medical devices.Party in2021year1month18Solstice2021year4month15During the date, there was class II operation without medical device registration certificate Behavior of class III medical devices,The total value of the products involved22100element,Total illegal income11900element.basis Regulations on the supervision and administration of medical devices 2017Revised in Article 63 and other provisions shall impose administrative penalties on the parties

1.Confiscate the illegal income of the party concerned11900element

2.Confiscate the medical devices and products illegally operated by the parties concerned

3.For the second category of the parties who have not obtained the medical device registration certificate The third kind of medical devices shall be fined298350element

4.Order the party concerned to correct the act of changing the address of business premises and warehouses without authorization,And impose a fine for this act16000element

5.Order the party concerned to correct the behavior of purchasing medical devices from unqualified individuals,And impose a fine for this act16000element.

three 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

2021year3month10day,During the on-site inspection of Guangzhou Ruimei medical beauty outpatient department Co., Ltd., the law enforcement personnel of Guangzhou Baiyun District market supervision and Administration Bureau,It is found that the parties concerned store relevant products without Chinese marks in the business premises.After investigation,According to the structure of the product involved Intended use Working principle, etc,The products involved shall be managed according to class III medical devices.The party concerned has the act of using class III medical devices that are not registered according to law,The total value of the products involved11900element.basis Regulations on the supervision and administration of medical devices 2017Revised in Article 66, paragraph 1 three term Article 68 two The parties shall be subject to administrative penalties in accordance with the provisions of paragraph

1.Order the party concerned to correct the behavior of failing to establish and implement the medical device purchase inspection record system, and give a warning

2.Order the party concerned to correct the use of medical devices that are not registered according to law

3.Confiscate the medical devices illegally used by the parties

4.fine89250element.

four Meishan market supervision and administration bureau investigated and dealt with the case of Meishan Yuemei Medical Beauty Co., Ltd. using unregistered medical devices

2021year3month16day,During the on-site inspection of Meishan Yuemei Medical Beauty Co., Ltd,It is found that the parties use relevant products without marked product information in the business premises.After investigation,The products involved were all unregistered medical devices,The act of the party acting two of the devices on the human body,Constitute an illegal act of using unregistered medical devices,The total value of the products involved11900element.basis Regulations on the supervision and administration of medical devices 2017Revised in The first paragraph of Article 66 stipulates that administrative penalties shall be imposed on the parties

1.Confiscate the illegally used medical devices

2.fine95700element.

five 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

2020year1month15day,When the law enforcement officers of Panzhihua market supervision and Administration Bureau conducted on-site inspection on Panzhihua zhengcha Medical Beauty Clinic Co., Ltd,Products without Chinese marks are found in the business premises of the parties.After investigation,It was determined that the products involved were unregistered medical devices.Panzhihua just in time medical beauty clinic Co., Ltd. used imported medical devices that were not registered according to law,The total value of the products involved46780element.basis Regulations on the supervision and administration of medical devices 2017Revised in Article 66, paragraph 1 three term Article 68, paragraph 1 two Items and other regulations,Impose administrative penalties on the parties

1.warning

2.Confiscate the illegally used medical devices

3.Confiscation of illegal income40448element

4.fine191345element.

six 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

2020year10month12day,During the on-site inspection of Shanghai ruilaili Medical Beauty Clinic Co., Ltd. by the law enforcement personnel of Shanghai Fengxian District market supervision and Administration Bureau,The party concerned failed to provide the qualification materials of relevant products on site.After investigation,The product involved has not obtained the medical device registration certificate.Shanghai ruilaili Medical Beauty Clinic Co., Ltd. used unregistered medical devices,The total value of the products involved76600element.basis Regulations on the supervision and administration of medical devices 2017Revised in Article 66 three Item provision,Impose administrative penalties on the parties

1.Confiscate the illegally used medical devices

2.fine498000element.