According to Article 81 of the Regulation on the Supervision and Administration of Medical Devices (202 1 Revision), those who deal in unregistered medical device products shall be fined between 0/5 and 30 times of the value of the goods; If the circumstances are serious, it shall be ordered to stop production and business, and the application for medical device license put forward by relevant responsible persons and units shall not be accepted within 10 years. The legal representative, principal responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall confiscate the income during the illegal act, impose a fine of more than 30% and less than 3 times the income, and prohibit the production and operation of medical devices for life. The original license-issuing department shall revoke the business license of medical devices.
The State Administration of Market Supervision has found that some e-commerce platforms have businesses illegally dealing in export products. Therefore, the possibility of products returning to the mainland market after export is not ruled out. The State Administration of Market Supervision suggests that when purchasing the COVID-19 antigen test kit, you should carefully check the outer packaging of the product, the font is generally simplified Chinese, and the machine name is marked. As of April 2nd, the State Administration of Pharmaceutical Products has approved 24 kinds of COVID-19 antigen detection reagent products. You can check the authenticity on the website of the State Administration of Pharmaceutical Products.