A Machinery Company Was Fined 30.33 million for Selling Such Medical Devices…
2022-07-27
On July 20, Hubei provincial market supervision bureau announced a typical 2022 “Iron Fist” action in the field of people’s livelihood (the fourth batch). In the case, a Wuhan Medical Device enterprise was directly fined and confiscated 30.33684 million for selling products without qualification certificates
According to the circular, on April 26, 2022, the market supervision bureau of Hong’an County, Huanggang City issued an administrative penalty of warning, confiscating 21810 medical masks without qualification certificates and imposing a fine of 30.33684 yuan against the illegal act of Wuhan Kangbenlong Medical Instruments Co., Ltd. in selling masks without qualification certificates.
According to the investigation, from September 2020 to February 2021, Wuhan Kangbenlong Medical Instruments Co., Ltd. sold 17002000 medical masks produced by a medical technology Co., Ltd. in Changsha to relevant companies and pharmacies in Wuhan, Hong’an and other places, with a sales amount of 3569040 yuan. When selling the above-mentioned medical masks, the party concerned did not provide qualification certificates, nor did they establish purchase inspection records and sales records as required. After verification, a medical technology Co., Ltd. in Changsha has never sold the above-mentioned medical masks to the party, nor provided qualification certificates. The behavior of the party concerned violated the relevant provisions of Articles 32 and 40 of the Regulations on the Supervision and Administration of Medical devices, and the market supervision bureau of Hong’an County, Huanggang City imposed administrative penalties on the party concerned according to law.
On October 27, 2021, Hubei Provincial Market Supervision Bureau handed over Wuhan Kangbenlong medical device Co., Ltd. to Hong’an County Market Supervision Bureau for investigation and punishment according to law for its suspected illegal operation of medical devices without qualification certificates.
Only one machinery enterprise fined more than thirty million, which is relatively rare in recent years!
Of course, in addition to fines, at the beginning of last month, the State Supreme People’s Procuratorate and the Ministry of Public Security also released four typical cases of punishing crimes impairing the prevention and control of epidemic diseases according to law. One of them was sentenced to three years for selling fake protective clothing, and another was arrested for selling fake antigen detection reagents.
On July 19, Zibo Market Supervision Bureau also announced ten typical cases of medical device safety, including the sale of unlicensed medical devices and other illegal acts.
Thirty times the fine for selling such medical devices!
In March this year, the NMPA has issued the Notice on Conducting the Investigation and Remediation of Hidden Risks of Medical Device Quality and Safety in 2022, which launched the special rectification of medical devices in 2022.
Once the notice was issued, all localities have successively deployed and conducted a severe crackdown on the unlicensed production and operation of medical devices for epidemic prevention.
Focusing on the investigation of enterprises that have changed production across the border since the outbreak of the epidemic, as well as enterprises that have found many problems in previous supervision and inspection, monitoring and evaluation, complaints， and reports, strengthen rectification efforts, and take follow-up inspection, follow-up sampling and other measures for enterprises that fail to rectify the problems. If there are serious problems, they shall be ordered to stop production and business in accordance with the law.
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