First, in accordance with the state clearly stipulates that sales of new crown antigen kits shall have a drug license or medical device license (6840 with in vitro diagnostic reagents), only to obtain the second class of the record shall not be retailed and wholesale, and new crown antigen is a class III The new crown antigen is a Class III medical device, and it is a criminal offense for unqualified companies and individuals to sell antigen!
Secondly, and then show you a case of selling new crown nucleic acid reagent was heavily fined 15 times (1.408 million) to remind everyone in addition to qualifications, the actual purchase and sale price, purchase and sale of the number of bank notes, etc. is also the direction of the rigorous investigation, the state will be followed by the current mess of remediation and processing, penalties. So cautioned not to be blinded by the interests, do antigen trading must be reasonable, compliant, legal!
01
State Council deployment of remedial action
The State Market Supervision and Administration Administration released the "anti-epidemic material product quality and market order of the special remedial action of the typical case". According to the official website disclosure, this rectification is in accordance with the CPC Central Committee, the State Council decision-making and deployment, the requirements of the local market supervision departments to comprehensively investigate the prevention of epidemic prevention material product quality and market order of the existence of hidden dangers, comprehensive rectification of the production, circulation, consumption of the existing outstanding problems. Market supervision departments around the rapid action, continue to increase supervision, according to the law from the strict and serious to quickly investigate and deal with a number of cases of violations, and effectively maintain the market order of epidemic prevention materials. It is observed that in this notification, the Beijing Yanqing District Market Supervision Bureau investigated and dealt with unauthorized engagement in Class III medical device business activities and the operation of medical devices not registered in accordance with the law. The parties involved in the case did not obtain a "medical device license", sales and donations of "coronavirus nucleic acid test kit" and "seven coronavirus nucleic acid test kit" *** count 95 boxes , the value of the goods *** count , the value of the goods *** count, the value of the goods *** count. , the value of the goods *** counted 93,322.42 yuan . Violated the "supervision and management of medical devices regulations" Article 31, paragraph 1 and Article 40 of the provisions. In view of the parties to the timely recall of "coronavirus nucleic acid test kit" 65 boxes , the recall ratio is large, according to the law on the parties to the forfeiture of a total of about 1.408 million yuan .02
Unauthorized operation is a big problem
From this briefing, we can see that the party's most important problem is that it did not obtain the "medical device license", "Medical Device Supervision and Administration Regulations" Article 31 The first paragraph and Article 40 of the Regulations for the Supervision and Management of Medical Devices, in short, "operating without a license". How is it described in the regulations? The regulations state that the operation of medical devices must obtain a "medical device license", nucleic acid test kits are classified as Class III medical devices. According to the regulations:Article 8: Class I medical devices to implement product record management, Class II, Class III medical devices to implement product registration management.
Article 22: Engaged in the production of Class II and Class III medical devices, the manufacturer shall apply to the food and drug supervision and management department of the people's government of the province, autonomous region and municipality directly under the Central Government for a production license and submit it to comply with the conditions of the provisions of Article 20 of the Ordinance to prove the information and the production of medical devices registration certificate.
Article 29: engaged in medical device business activities, there should be with the scale and scope of business operations and storage conditions, and with the operation of medical devices and quality management system and quality management organizations or personnel.
Article 31: Engaged in the third class of medical equipment business, the business enterprise shall be located in the municipal people's government food and drug supervision and management department to apply for a license to operate and submit its compliance with the conditions set out in Article 29 of the Regulations to prove the information.
Article 40: Medical device business enterprises, the use of units shall not be operated, the use of non-registered in accordance with the law, no qualification documents, as well as expired, expired, out of medical equipment.
03
Multiple parties are jointly and severally liable
The sales were more than 90,000 yuan and the penalty was 1.4 million yuan. How was the penalty amount ordered. On June 25, 2018, the Ministry of Justice published the "Medical Device Supervision and Administration Regulations Amendment (Draft for Review)", mainly for the prominent problems in the regulatory practice, targeted additions, some of the penalty standards have become heavier, increase the penalty to the provisions of the person, the penalty standard for enterprises has also been increased more than ever, the industry regulation has never been stricter. The Draft Amendment makes it clear that the production and operation of counterfeit medical devices, unauthorized production and operation activities: Within 10,000 yuan of the value of the goods, the fine standard is adjusted from 50,000 to 100,000 yuan for 10-15 million yuan; the value of the goods is more than 10,000 yuan, the fine standard is adjusted from the value of the goods of the amount of 10-20 times the value of the goods of the amount of 15-30 times.The penalty in this case is just 15 times the value of the goods.
According to the in vitro diagnostics network analysis, in the industry dealers for the first time to buy goods, manufacturers should require dealers to provide qualifications to prove that the dealer is qualified and meet the requirements of the relevant state regulations before choosing to cooperate. If the dealer can not provide qualifications, the manufacturer sells the product to the dealer, as the manufacturer, is jointly and severally liable. In other words, the producer is responsible for determining whether his dealer has legal procedures and legal qualifications. For dealers who do not have legal business qualifications, perhaps there is no standardized warehousing (cold chain transportation). If the new crown reagent flows into the medical terminal through such a merchant, how can the quality of the reagent be guaranteed? So, here we in vitro diagnostics network to prompt all IVD manufacturers and IVD distributors, to standardize the legal business, not because of the temptation of the momentary interests and touch the bottom line of the law and regulations.04
Law Enforcement Matters List (2020 Edition) is here
It can be seen that the market supervision departments across the country this time to comprehensively check the product quality of the anti-epidemic materials and the market order of the hidden dangers, comprehensively Rectification of production, circulation and consumption of the outstanding problems. The National Health Insurance Bureau also recently released a list of administrative enforcement matters (2020 version), from the content, covering 16 items, involving medical institutions, various types of enterprises, natural persons and many other items, involving areas such as the use of high-value consumables, procurement and so on. The 2020 version of the list, Article 6, Article 8, pointed out that the public medical institutions will be high-value medical supplies centralized purchasing behavior compliance supervision and inspection; public medical institutions centralized purchasing behavior compliance supervision and inspection of drugs. The enforcement of these two measures is based on the "National Medical Security Bureau function configuration, internal institutions and staffing regulations", which specifies that the National Medical Security Bureau to develop the bidding and purchasing policies for drugs and medical consumables and supervise the implementation, and to guide the construction of the bidding and purchasing platform for drugs and medical consumables.The actual purchase and sale prices and purchase and sale quantities are also the direction of strict investigation.
The list points out that the supervision and inspection of the actual purchase and sale prices and purchase and sale quantities of their drugs will be provided to the drug price authorities by the drug listing license holders, drug manufacturers, drug business enterprises and medical institutions, and the relevant responsible persons will provide the inspection department with the actual purchase and sale prices and purchase and sale quantities of their drugs and other information. It is understood that the bills and information of medical institutions are the focus of the inspection. At the same time, the books, bills, vouchers, documents and other information related to price violations will be queried and copied, and bank information related to price violations will be verified.Advertising, business cooperation:Jin Manager 13072506726