China News Service, December 28. According to news from the official website of the State Food and Drug Administration on the 28th, recently, the State Food and Drug Administration has organized drug supervision and management departments at all levels to strengthen the quality and safety supervision of the new coronavirus antigen detection reagents, and further strengthen the registration of the new coronavirus antigen detection reagents. Supervise and inspect people, production and operation enterprises, and third-party platforms for online trading services, increase online and offline supervision and law enforcement, and severely crack down on violations of laws and regulations.
The drug regulatory authorities at all levels took active actions, and investigated and dealt with a number of violations of laws and regulations.
1. The case of greedy mouth food store in Bengbu Economic Development Zone, Anhui Province suspected of operating the third class of medical devices without permission
On December 14, 2022, the Market Supervision and Administration Bureau of Bengbu City, Anhui Province received a report from the masses that the Qiankouxin Food Store in the Bengbu Economic Development Zone released information on the sale of drugs in the WeChat group. Law enforcement officers immediately went to the store for verification. Several boxes of new coronavirus antigen detection kits were found, and the parties involved were suspected of operating third-class medical devices without permission.
The Bengbu Market Supervision and Administration Bureau seized the items involved in the case and filed a case for investigation.
At the same time, the Bengbu Market Supervision and Administration Bureau, in conjunction with the public security organs, is investigating its upstream operators.
Currently, the case is under further investigation.
2. Gongming Pharmaceutical Store in Xiao County, Anhui Province suspected of operating Class III medical devices without a license
On December 15, 2022, the Market Supervision and Administration Bureau of Xiaoxian County, Anhui Province discovered during supervision and inspection that Xiaoxian Gongming Pharmaceutical Store was selling new coronavirus antigen detection reagents, and unsold drugs were seized from ambulances parked in the pharmacy and at the entrance of the pharmacy. A total of 348 boxes of new crown antigen reagents (8700 people), suspected of engaging in the operation of third-class medical devices without permission.
Law enforcement officers seized the above-mentioned items involved in the case on the spot and filed a case for investigation.
Currently, the case is under further investigation.
3. Hebei Province Hengshui Huichang Trading Co., Ltd. and Hengshui Yuandun Trading Co., Ltd. are suspected of operating third-class medical devices without permission
The Market Supervision and Administration Bureau of Jizhou District, Hengshui City, Hebei Province, when inspecting medical device online sales stores, found that two stores on the Meituan platform were selling new coronavirus antigen detection reagents.
The Jizhou District Market Supervision and Administration Bureau immediately conducted on-site inspections of the two companies, preliminarily determined that they were suspected of illegal activities, and filed a case on December 8, 2022.
After investigation, Hengshui Huichang Trading Co., Ltd. opened a store on the Meituan platform to sell new crown antigen detection kits and other products. The Meituan platform showed that the sales volume of its new crown antigen detection kit products in December 2022 was 664 orders. Qualification for operating Class III medical devices.
Hengshui Yuandun Trading Co., Ltd. opened a store on the Meituan platform to sell new crown rapid detection kit self-test cartons and other products. The Meituan platform shows that the sales volume of its new crown rapid detection kit self-test carton products in December 2022 is 595 orders , the company has not obtained the qualification to operate Class III medical devices.
The Jizhou District Market Supervision Administration has sent a letter of assistance to the Beijing Haidian District Market Supervision Administration to assist in obtaining all sales data of the above two companies on the Meituan platform.
Currently, the case is under further investigation.
4. The case of Mr. Wang suspected of operating a Class III medical device without a license and without obtaining a medical device registration certificate
On December 14, 2022, the Hebei District Market Supervision and Administration Bureau of Tianjin received a report and conducted an on-site inspection of the "big pot fried skewers shop" located in Yinjiang River, Yueyahe Street, Hebei District. On the spot, it was found that Wang had 8 boxes (specifications: 5 pieces/box) a total of 40 items involved in the case, the outer packaging of the items involved in the case was printed with English information, no product registration information was found, and the party concerned could not provide the purchase certificate and qualification certificate of the above items on the spot. According to the statement of the party concerned, the above items were his New coronavirus antigen detection reagents for sale.
The value of the medical devices involved in the sale by the parties involved was 520 yuan.
The investigation of this case has now been concluded, and the Hebei District Market Supervision and Administration Bureau of Tianjin City intends to confiscate the medical devices involved in the case and impose administrative penalties on the parties concerned.
5. Tianjin 5mm Architectural Design Co., Ltd. is suspected of operating the third class of medical devices without permission
On December 12, 2022, the Hexi District Market Supervision and Administration Bureau of Tianjin City discovered during the supervision and inspection that Tianjin 5mm Architectural Design Co., Ltd., without a business license, put the third-class The new coronavirus (2019-nCoV) antigen detection kit (latex method) for medical devices (specification 25 servings/box) is sold to others.
After investigation, the value of the goods involved in the case was 3,375 yuan, and the illegal income was 2,025 yuan.
At present, the Market Supervision and Administration Bureau of Hexi District has issued a notice of administrative punishment to the parties concerned.
6. "1216" Unauthorized Sales of Novel Coronavirus Antigen Detection Reagent Case
On December 16, 2022, the Market Supervision and Administration Bureau of Jimei District, Xiamen City, Fujian Province, jointly with the local public security organs, inspected a hotel in Jimei District, Xiamen City, and seized 12 people involved in the case, and seized 34 boxes with a total of 16,925 copies of the new crown virus. Antigen detection kit.
After investigation, the party Ma and 2 other personnel sold the new coronavirus antigen detection kit to others by telephone and WeChat contact information in the hotel, which was suspected of constituting the crime of illegal business operation, and the suspected criminal case has been transferred to the public security organ.
Another 9 purchasers have illegal facts of engaging in the sale of third-class medical devices without permission, and the Jimei District Market Supervision and Administration Bureau opened a case for investigation on December 16, 2022.
At present, the Jimei District Market Supervision Administration is actively cooperating with the public security organs to further investigate the purchase situation, sales flow and product authenticity of the new coronavirus antigen detection kit involved in the case.
7. The case of Xie Moumou in Deyang City, Sichuan Province engaging in third-class medical device business activities without permission and operating a new coronavirus antigen detection reagent that has not obtained a medical device registration certificate
On December 11, 2022, when the Market Supervision and Administration Bureau of Zhongjiang County, Sichuan Province was monitoring online business activities, it was discovered that someone was selling new coronavirus antigen detection reagents through WeChat groups and Moments, and will be released at 17:30 on December 14. Trading at the gate of a certain community is suspected of engaging in the third-class medical device new coronavirus antigen detection reagent business activities without a license and operating the new coronavirus antigen detection reagent without a medical device registration certificate.
The Zhongjiang County Market Supervision Administration and the local public security organs seized 50 copies of the new coronavirus antigen detection reagent with full English labels, instructions, and unmarked registration certificate numbers, and the salesperson Xie Moumou, and found 13 copies of the same type of new crown virus on his vehicle. Viral antigen detection reagents.
At present, the Zhongjiang County Market Supervision and Administration Bureau has opened a case for investigation.
At the same time, it was found that the antigen reagent sold by Xie Moumou came from Sichuan Sanqitang Pharmacy Co., Ltd. in Chongzhou City, Chengdu. The case handling agency has handed over the relevant illegal clues to the Chongzhou Market Supervision Administration, which is following up. Investigate the situation.
8. The case of Du Mou suspected of operating and operating unregistered third-class medical devices without permission
On December 20, 2022, after receiving the report, the inspection brigade of Xinghua City Market Supervision and Administration Bureau, Taizhou City, Jiangsu Province carried out law enforcement inspections on the reported sales outlets, and found that Du Mou sold them at a price of 6-10 yuan per stick through WeChat Moments. New coronavirus antigen detection reagents, 2,500 new coronavirus antigen detection reagents packaged without any label were seized on the spot, and the party concerned did not obtain a third-class medical device business license.
The parties engaged in the operation of Class III medical devices without permission and the operation of unregistered Class III medical devices are suspected of violating the relevant provisions of the "Regulations on the Supervision and Administration of Medical Devices", and the Xinghua City Market Supervision Administration has filed a case for investigation.
9. Henan Youde Biotechnology Co., Ltd. is suspected of producing unlicensed third-class medical devices and unregistered new coronavirus antigen detection reagents
On December 12, 2022, the Market Supervision and Administration Bureau of Zhengzhou City, Henan Province inspected Henan Youde Biotechnology Co., Ltd.
After investigation, the antigen detection reagent produced by the party concerned is an exported new coronavirus antigen detection reagent, which is directly sold in the domestic market without obtaining a medical device production license and product registration certificate in China.
The Zhengzhou Municipal Market Supervision and Administration Bureau has filed an investigation into the party's unauthorized production of unregistered antigen detection reagents.
Currently, the case is under further investigation.
(China New Finance and Economics)
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