The National Medical Products Administration has released information on four cases of medical device violations
2024-09-04
According to the website of the National Medical Products Administration, the drug regulatory authorities have thoroughly implemented the decisions and deployments of the Party Central Committee and the State Council, solidly promoted the consolidation and improvement of medical device safety, continuously strengthened the supervision of medical device quality and safety, severely cracked down on illegal and irregular behaviors in the field of medical devices, and lawfully investigated and dealt with a number of illegal cases, effectively safeguarding the health and safety of the people's use of medical devices. On June 16, 2023, the Hubei Provincial Medical Products Administration conducted a routine inspection of Wuhan Tianshunwei Medical Equipment Co., Ltd. for producing Class III medical devices without obtaining a medical device registration certificate. After investigation, the party involved produced a Class III medical device "personalized base station" without obtaining a medical device registration certificate, with a total value of 12000 yuan and illegal gains of 12000 yuan. The above-mentioned behavior of the parties violates Article 13 (1) of the Regulations on the Supervision and Administration of Medical Devices. On October 19, 2023, the Hubei Provincial Medical Products Administration imposed administrative penalties on the parties involved, including confiscation of equipment and raw materials used for illegal production and operation, confiscation of illegal gains of 12000 yuan, and a fine of 322200 yuan, in accordance with Article 81, Paragraph 1, Item 1 of the Regulations on the Supervision and Administration of Medical Devices. 2、 On January 3, 2024, Shaanxi Provincial Medical Products Administration conducted an on-site inspection of Shaanxi Jianchi Biopharmaceutical Co., Ltd. based on reported clues regarding the non-compliance of its production instructions and labels with Class I medical devices. Through investigation, the use method in the instructions and labels of the first class medical device "medical antipyretic gel" produced by the party concerned is inconsistent with the contents of the record, and there is a refusal to correct. The above-mentioned behavior of the parties violates Article 39 (1) of the Regulations on the Supervision and Administration of Medical Devices. On April 2, 2024, the Shaanxi Provincial Medical Products Administration imposed an administrative penalty of a fine of 85000 yuan on the party concerned in accordance with Article 88, Paragraph 2 of the Regulations on the Supervision and Administration of Medical Devices. 3、 On February 22, 2024, the Market Supervision Administration of Baicheng City, Jilin Province, conducted an on-site inspection of the Yuxing Yiwu Small Commodity Store in Baicheng City based on reported clues regarding the unauthorized operation of Class III medical devices. After investigation, the parties involved did not obtain a medical device business license and sold Class III medical devices such as "soft hydrophilic contact lenses" without qualified certification documents. The value of the goods involved was 659.4 yuan, and the illegal gains were 390.3 yuan. The above-mentioned behavior of the parties violates Article 42 (1) and Article 55 of the Regulations on the Supervision and Administration of Medical Devices. On May 20, 2024, the Market Supervision Administration of Baicheng City, in accordance with Article 81 (1) (3) and Article 86 (3) of the Regulations on the Supervision and Administration of Medical Devices, ordered the parties to rectify their illegal behavior and imposed administrative penalties of confiscating the products involved, confiscating the illegal gains of 390.3 yuan, and imposing a fine of 50000 yuan. 4、 On August 15, 2023, the Market Supervision Administration of Nanming District, Guiyang City, Guizhou Province conducted an on-site inspection of the staff hospital of Guiyang Steel Plant regarding the use of expired medical equipment. After investigation, the party involved used expired medical equipment "hemolytic agent for blood cell analysis", with a total value of 1451.52 yuan. The above-mentioned behavior of the parties violates Article 55 of the Regulations on the Supervision and Administration of Medical Devices. On November 12, 2023, the Market Supervision Administration of Nanming District, Guiyang City, in accordance with Article 86 (3) of the Regulations on the Supervision and Administration of Medical Devices, ordered the parties involved to rectify their illegal behavior and imposed administrative penalties such as confiscation of the involved products and a fine of 30000 yuan. (New Society)
Edit：HAN ZHUOLING Responsible editor：CAICAI
Source：people.com
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