The industry giant Thermo Fisher Scientific (China) Co., Ltd. (hereinafter referred to as "Simofly") was fined nearly 800,000 yuan for operating in vitro diagnostic reagents that did not obtain a medical device registration certificate. The Beijing Business Daily reporter found that since April this year, the Shanghai Food and Drug Administration has issued a fine of 430,000 yuan, 210,000 yuan, 540,000 yuan and 800,000 yuan for the four companies to operate unlicensed medical devices. The emergence of intensive fines may indicate that China's drug regulatory authorities have increased supervision over the operation of unlicensed medical device violations.

Violation of sales is fined

In vitro diagnostic reagent industry giant foreign company Thermo Fisher was fined for illegal sales of unlicensed medical devices. According to the Shanghai Food and Drug Administration, after the investigation, Thermo Fisher purchased the batch number “DN2B3” from the Swedish manufacturer PhadiaAB on August 20, 2015, August 24, 2015 and February 17, 2016, respectively. ", production date is September 2014 weed pollen mixed WX5 allergen-specific IgE antibody detection kit (fluorescence immunoassay) 1035 boxes.

At the time, these reagents cost about 279.45 yuan per box. Since then, from September 2015 to March 2016, Thermo Fisher has sold to 12 dealers at a price of 576.27 yuan/box, and sold to 1 dealer at a price of 658.6 yuan/box. A total of 525 boxes of medical equipment involved in the case were sold.

According to the survey results, the above-mentioned reagents obtained the medical device registration certificate of the People's Republic of China on February 27, 2015, and the batch of medical devices involved in the case was produced in September 2014. The regulatory authorities determined that the manufacturer did not obtain the medical device registration certificate when producing the batch of medical devices involved in the case, and that the production of the medical devices involved in the case by Thermo Scientific constituted a medical device that was not legally registered.

According to investigations by the regulatory authorities, when the case was filed, Thermo Fisher had recalled 175 boxes of medical equipment involved in the case, and the illegal income of Thermo Flying was 104,000 yuan. In response to the above-mentioned violations by Thermo Fisher, the Shanghai Pudong Market Supervision Bureau recently made an administrative penalty decision, fined the company with 295,000 yuan, confiscated 104,000 yuan of illegal income, and confiscated 3.9 million yuan of illegal property, totaling about 78. .80 million.

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