Can you be fined 70,000 yuan for selling condoms?
Anyone who buys a shoddy condom -
The drama of "accidental pregnancy ~ happy to be a father" rocked the stage!
Case review one
Pingzhou, a store owner Mr. Wu did not expect to sell a small condom was actually fined 70,000 yuan!
The matter traces back to the beginning of 2017, law enforcement officers in Pingzhou, a store inspection, found that the store counter is selling a brand of condoms, so the law enforcement officers on the spot to require Mr. Wu to provide the "second class of medical equipment business filing voucher", as well as the relevant condoms of the purchase of information. Mr. Wu, however, was at a loss, and had no idea what to ask for in terms of credentials and purchase information.
Later, Mr. Wu was investigated and explained that his condom business did not obtain the "Class II Medical Device Business Record Certificate", and the condoms sold were only purchased in the wholesale market, and did not ask the other side for any purchase certificate and seller's relevant information.
And at the same time, law enforcement officials sent Mr. Wu's condoms to the brand company for identification. After identification, the whole batch of condoms belonged to counterfeit and shoddy products. Law enforcement officers warned Mr. Wu according to the law, confiscated the condoms on the shelves as well as the illegal income of 167 yuan, while imposing a fine of 70,000 yuan on Mr. Wu.
Case Review 2
In 2017, the Guicheng Food and Drug Administration Branch received a report and complaint that a brand of condoms bought at a convenience store were suspected to be counterfeit.
Law enforcement officers of Guicheng Food and Drug Administration Branch came to the convenience store and conducted on-site inspection of a brand of condoms on the shelves of the store and found that: the printing of the relevant products' outer packages was blurred, and there was the phenomenon of labeling multiple approval numbers for products produced in the same year, and there was no relevant instruction manual attached to the individual product packages.
Li Mou (a pseudonym), the person in charge of the store, failed to show the "Class II Medical Device Business Record Certificate" and a brand of condom's legal supplier's license, purchase vouchers, medical device registration certificate, etc. In accordance with the relevant regulations, the law enforcement officers seized all the condoms on sale in the store on the spot, and opened a file for investigation of Li Mou's suspected operation of counterfeiting condoms.
Finally, a brand company confirmed that the products seized by law enforcement officers were counterfeit. In the investigation and questioning, Li admitted that he did not apply for the "Certificate of Record for the Operation of Class II Medical Devices" and could not show the legal licenses and purchase certificates of some suppliers of a certain brand of condoms.
In accordance with the relevant legal provisions, a brand of condoms operated by Li was identified as counterfeit, constituting the operation of medical devices not registered in accordance with the law, in violation of Article 40 of the "Regulations for the Supervision and Administration of Medical Devices", and should be given: 1. confiscation of illegal income; 2. confiscation of illegal operation of medical devices; 3. impose a fine of 50,000 yuan or more than 100,000 yuan or less.
Why sell a small condom,
to be fined 70,000 yuan so much?
Related laws and regulations
According to Article 4 of the Regulations for the Supervision and Administration of Medical Devices: the state implements classification and management of medical devices in accordance with the degree of risk.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices; The second category is a medium risk, need to strictly control the management to ensure its safety and effectiveness of medical devices; The third category is a high risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.According to the Medical Device Classification and Determination Table, contraceptive and family planning devices (excluding reusable surgical devices) are passive medical devices that come into contact with the human body and belong to Class II medical devices.
What are the regulations for that specific type of medical device?
"Supervision and Administration of Medical Devices Regulations" Article 29 provides that engaged in medical device activities, there should be with the scale and scope of operation of the business premises and storage conditions, as well as with the operation of medical devices and quality management system and quality management organizations or personnel. According to Article 30 and 31 of the Regulations, those engaged in the operation of Class II medical devices must be filed and submit the corresponding supporting materials. While the operation of Class III medical devices must apply for permission and obtain a business license to operate.
Corresponding to the law of Article 63 (a) provides that the production and operation of medical devices without obtaining the certificate of registration of the second class, the third class of medical devices and (c) unauthorized to engage in the operation of third-class medical devices, by the people's government at or above the county level of food and drug supervision and management department to confiscate the illegal income, the illegal production and operation of medical equipment and tools used in illegal production and operation The illegal production and management of medical devices less than 10,000 yuan in value, and impose a fine of 50,000 yuan or more than 100,000 yuan; value of more than 10,000 yuan, and impose a fine of 10 times the amount of 10 times the amount of 20 times the amount of the goods; the circumstances are serious, within five years will not be accepted by the person responsible for the relevant and the enterprise to submit an application for licensing of medical devices.
At the same time, the first paragraph of Article 32 of the medical device business enterprises, the use of units purchasing medical devices, should check the qualifications of the supplier and the medical device qualification documents, the establishment of purchase inspection record system. Engaged in the second, third class medical equipment wholesale business and third class medical equipment business enterprises, should also establish a sales record system.
According to Article 68 (2) of the medical device business enterprises, the use of units not in accordance with the provisions of this regulation to establish and implement the medical device purchase inspection record system, by the people's government at or above the county level food and drug supervision and management department ordered to make corrections, and give a warning; refused to make corrections, impose a fine of 5,000 yuan more than 20,000 yuan; the circumstances are serious, ordered to cease production and suspend business until the original licensing department revoked the medical devices. By the original licensing department to revoke the medical device production license, medical device license.