Six medical device companies in Guangdong were suspended from production

According to relevant information, in the third quarter of this year, 288 cases of medical device cases were filed in the province, 217 cases were closed, 9 cases were handed over to the public security organs, and 8 cases were filed. The administrative punishments for the suspension of production and business suspension for 6 companies were fined 528.6. Ten thousand yuan, three licenses for medical device operation companies were revoked, and six fake and fake dens were destroyed. In the risk investigation and special rectification work of in vitro diagnostic reagents, it was found that there were three unidentified in vitro diagnostic reagents in the top three hospitals. It is reported that in order to ensure the safety of in vitro diagnostic reagents, from April to July this year, the Guangdong Food and Drug Administration began a special rectification work. During the rectification period, 49 production companies were ordered to rectify, 182 companies were operated, and 425 units were used.

According to the introduction, it was found that the medical status of a single tertiary medical institution in Guangzhou was based on research and development, using imported and unapproved in vitro diagnostic reagents, and the use of “undocumented” in other localities also existed. It is reported that in vitro diagnostic reagents are mainly used to assist clinicians to diagnose the results of treatment. Although they do not directly affect patients, they are still non-standard actions.

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