Unlicensed production, production without a license | Medical machinery company was fined 6 million yuan

The medical network reported on May 3 'Unlicensed production' and 'Production-free', a company was directly fined 6 million yuan.

Recently, the Market Supervision Bureau of Jiaxing City, Zhejiang Province announced the 2017 market surveillance system for the entire country. drug Top ten typical cases', which, medical instruments In the field of undocumented production, medical device cases without registration certificates were selected and involved enterprise Penalty was not nearly 6 million yuan.

According to the case information, on October 20, 2016, the Market Supervision Bureau of Jiaxing conducted supervision and inspection of Taikang Textile Co., Ltd. of Jiaxing according to the information of the provincial associations and found that the company did not obtain the “Medical Device Production License” and “medical device”. In the case of Product Registration Certificates, the falsification of the medical information of a medical science and technology enterprise in Beijing and its registered second category of medical device product information resulted in the illegal production of 10,000 boxes of 'pressure anti-snag straps' for medical device products.

The above products have all been sold to Shanghai Yiyi Textile Co., Ltd., with a total sales amount of 335,000 yuan. On April 25, 2017, the Jiaxing Market Supervision Bureau imposed a total of 335,000 yuan on confiscation of the illegal proceeds and imposed a fine of 5.695 million yuan on the company. Punishment.

The fine of up to RMB 6 million resulted in the case being the largest administrative penalty case in the field of medical devices in Jiaxing City. It was also included in the top ten typical cases of edible drugs in 2017 in Zhejiang Province, as well as the outstanding cases of enforcement by the State Food and Drug Administration.

In medical device-related cases, undocumented production, operating medical devices, and production, business operations, and the use of unlicensed medical devices have continued to occur in recent years. The intensity of cracking down on drugs has also become increasingly stringent.

Not long ago, the newly listed State Drug Administration issued a red-headed document to set off a nationwide campaign to address the issue of unlicensed medical devices and the use of unlicensed medical devices. The special rectification is not only aimed at offline operations, but also online sales of medical devices. Online and offline operations are conducted at the same time. Their power and power are irresistible. The drug manager's determination is not too great.

The National Physician Supervision Conference held earlier this year has also confirmed that 1018 cases a year and a half ago will continue to be investigated this year and have not been completed.

In this link of production, the supervision of unlicensed medical devices, production of counterfeit brands, and unlicensed medical devices has never been relaxed.

In addition to the above-mentioned case where Jiaxing City investigated and handled fines of up to 6 million last year, last month, the Guangdong Provincial Food and Drug Administration also issued a heavier administrative penalty fine for a company to produce unlicensed medical devices.

Guangzhou Huirun Medical Equipment Co., Ltd. produced a third type of medical device plasma cutting ring that did not obtain a medical device registration certificate and was revoked by the Guangdong Provincial Food and Drug Administration under the “Regulations on the Supervision and Management of Medical Devices” to revoke the production license of medical devices. Accept administrative penalties for applications for production licenses for medical devices submitted by the company and legal entities.

In addition to the administrative penalties for high fines, hanging permits, etc., the production and production of unlicensed instruments without a license may also violate the criminal law, and the relevant personnel must eat the food.

In November last year, the joint public security agency of the Food and Drug Administration of Tianhe District of Guangzhou City investigated and ran a den of unlicensed cosmetic medical devices.

The “Dest” produces unlicensed picosecond laser Class III medical devices without a license. The value of the picosecond laser instrument involved exceeds RMB 500,000, plus the total value of the Photon Skin Rejuvenation Instrument exceeds RMB 10 million. 2. The public security authorities arrested 26 suspects at the scene, followed by 16 detainees, and one person was released on bail due to pregnancy.

In September last year, the Joint Public Security Bureau of the Food and Drug Administration of Hebi City, Henan Province, also investigated and managed a counterfeit condom used to manufacture and process counterfeits. Law enforcement officers seized 7 brands of finished brand condoms in 15 boxes, a total of 53,339, worth 24 Ten thousand yuan. Public security agencies have conducted investigations on the case of counterfeit registered trademarks of the staff of the processing dens. The case is currently under further processing.