Concerning the new coronavirus antigen detection reagents! Kunming Municipal Market Supervision Bureau issued a reminder to inform

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December 29, Kunming Municipal Administration of Market Supervision issued a reminder on the regulation of the operation of the new crown virus antigen detection reagents informed. Details are as follows.

The new coronavirus antigen detection reagents operating enterprises.

In order to conscientiously implement the State Council joint prevention and control mechanism comprehensive group “on further optimization of the implementation of the new crown pneumonia epidemic prevention and control measures notice” (joint prevention and control mechanism comprehensive hair [2022] 113) and “on the issuance of the new crown virus antigen detection application program notice” (joint prevention and control mechanism comprehensive hair [2022] 118), effectively regulate the new crown virus antigen detection reagents business practices, to ensure that the people The masses with mechanical safety, Kunming Municipal Bureau of Market Supervision is now reminded to inform the following.

A. Compliance in accordance with the law

(a) the new coronavirus antigen detection reagents (hereinafter referred to as antigen reagents), refers to the new coronavirus antigen self-test products, belongs to the third category of medical devices, subject to the State Drug Administration approved medical device registration certificate.

(B) in the epidemic prevention and control period, for individual consumers to sell antigen reagents units should have the following conditions: to obtain a drug license or medical device license, and have the appropriate storage conditions of retail pharmacies and medical equipment retail enterprises. Any individual shall not sell antigenic reagents in any form.

(C) in order to effectively alleviate the supply of antigen reagents market tension in Kunming, the maximum to meet the needs of the masses of antigen reagents, in the medical device retail link can be split zero sales of antigen reagents. Retail pharmacies, medical equipment retail enterprises according to the public’s self-testing needs, guidance and reasonable purchase of antigenic reagents, single person single purchase generally does not exceed five copies. (This measure is implemented for a tentative period of three months)

(D) obtain medical device business license and its business scope includes “6840 in vitro diagnostic reagents”, the business mode contains “wholesale” medical device business enterprises before wholesale antigen reagents.

(E) in accordance with the principle of consistency between online and offline, network sales of antigenic reagents companies need to comply with the above provisions and retail pharmacies should be in accordance with the “supervision and management of pharmaceutical network sales” Article 11 of the provisions of the report to the local city and county drug supervision and management departments, medical device business enterprises need to apply for medical device network sales record.

Second, to ensure quality and safety

Antigen reagent business enterprises should strictly comply with the “supervision and management of medical devices regulations” “supervision and management of medical devices” and other laws and regulations, compliance with the law, and effectively fulfill the main responsibility for quality and safety, to ensure product quality and safety.

(A) to ensure the legitimacy of the product, from a legally qualified supplier to purchase the antigen reagents approved by the registration and have qualified documents.

(B) strictly implement the purchase inspection and sales record system to ensure that product information can be traced, and strictly prohibit the sale of expired, invalid, eliminated antigen reagent products.

(D) strengthen the epidemic prevention and control of medical device adverse events monitoring, the occurrence of adverse events, timely reporting and take effective measures to control the risk of using firearms.

(E) retail sales of antigen reagents for retail sales, to do a good job in the sale of quality management, information traceability management, to properly retain the original packaging and instructions, to provide consumers with the corresponding instructions (electronic photos or copies, etc.), remind consumers to use antigen reagents in strict accordance with the instructions to ensure consumer safety.

(F) engaged in network sales of medical devices business enterprises, to prominently display the main page of the website medical device license, to display the product page medical device registration certificate and other information, not illegal to carry out network sales activities.

Third, regulate the price behavior

To further regulate the price behavior of antigen reagents, the strict implementation of the price tag system, follow the “fair, legal and honest and trustworthy” principle, according to the cost of production and operation, to provide consumers with reasonably priced goods and services. To strictly comply with the State Administration of Market Supervision to draw the “nine shall not” red line, abide by the law and operate in accordance with the rules, to maintain the normal market price order.

Fourth, the relevant legal responsibility

Strictly prohibit the operation of unlicensed, operating unregistered antigen reagents. Individuals may not engage in Class III medical devices (including Class II) business activities, individuals in the circle of friends and other network platforms to sell antigenic reagents are illegal. Operating without a license, operating unregistered antigen reagent violations, will be punished by confiscating the illegal income, illegal operation of medical devices; the amount of goods worth less than 10,000 yuan, and impose a fine of more than 50,000 yuan 150,000 yuan; the amount of goods worth more than 10,000 yuan, and impose a fine of more than 15 times the amount of goods worth more than 30 times; the circumstances are serious, ordered to cease operations, 10 years not to accept the relevant responsible person and the unit proposed Medical device license applications, the legal representative of the offending unit, the main person in charge, directly responsible for the competent personnel and other responsible personnel, confiscate the income earned from the unit during the violation, and impose a fine of more than 30% of the income earned more than three times the lifetime ban on its medical device business activities; suspected of a crime, will be transferred to the public security organs shall be held criminally responsible.

Please operate the enterprise to seriously comply with the above reminder to inform the requirements to further standardize business practices. The general public and the community if the above illegal behavior, please save the relevant evidence, promptly call “12315” for complaints and reports.