Zhongxin Finance, April 11. According to the Shenzhen market supervision official account, there was a report that a pharmacy in Luohu District sold unlicensed new crown antigen detection kits.
During the on-site inspection, the law enforcement officers of the Market Inspection Bureau of Shenzhen Market Supervision and Administration found that there were 48 kits of COVID-19 antigen detection kits from a certain brand in the pharmacy.
The product involved was produced by a medical device enterprise in Nanshan District, Shenzhen, and was an export product of the company. It has not obtained the domestic "Medical Device Registration Certificate".
The products involved were illegally purchased from a medical device operating company in Longhua District, and law enforcement officers conducted in-depth investigations into the production and operating companies.
It is understood that the products involved are indeed exported products produced by a medical device company in Nanshan District, and have been identified as the version exported to Hong Kong by the manufacturer, and all the products in this batch were sent to Hong Kong customers.
The medical device operating company in Longhua District claimed that the products involved were purchased from other places, and the relevant situation is still under further investigation and verification.
According to Article 81 of the "Regulations on the Supervision and Administration of Medical Devices" (revised in 2021), for the operation of unregistered medical device products, a fine of 15 times but not more than 30 times the value of the goods shall be imposed. For the medical device license application submitted by the relevant responsible person and the unit, the legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income obtained from the unit during the period of the illegal act, and the property shall be punished. If the income is more than 30% but less than 3 times of the income, it will be banned from engaging in medical device production and operation activities for life, and the original license-issuing department will revoke the medical device business license.
Recently, the Shenzhen Municipal Bureau of Supervision found that some e-commerce platforms have merchants illegally operating export versions of products.
Therefore, it cannot be ruled out that the products will return to the mainland market after export.
The Shenzhen Municipal Bureau of Supervision reminds that when purchasing a new crown antigen detection kit, you must carefully check the outer packaging of the product. The font is generally simplified Chinese, and the mechanical font size is marked.
As of April 2, the State Food and Drug Administration has approved 24 new coronavirus antigen detection reagent products. You can log on the website of the State Food and Drug Administration to check the authenticity.
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