China Quality News Network News On February 23, 2022, the Beijing Municipal Drug Administration website released the “Beijing Drug Administration”. The Announcement of the Supervision and Administration Bureau on the Release of the Second Phase of Beijing Medical Device Quality and Safety in 2021 showed that 10 batches of medical device products did not meet the regulations. Relevant units have taken necessary control measures for unqualified medical device products, and investigated and dealt with unqualified products in accordance with relevant laws and regulations.
The non-compliant medical device products announced in this issue include disposable medical masks, medical surgical masks, medical protective masks, etc. The indicated production units involve Changchun Hengxiao Biotechnology Co., Ltd., Hunan Kanglilai Medical Equipment Co., Ltd., Guangdong Meishida Pharmaceutical Packaging Materials Co., Ltd., Nanchang Yierkang Medical Equipment Co., Ltd., Guangxi Anran Medical Equipment Co., Ltd., Hebei Shian Medical Equipment Co., Ltd., Xinxiang Dafang Medical Equipment Manufacturing Co., Ltd., Hebi Likang Sanitary Materials Co., Ltd., Jiangxi Yuansheng Langhe Pharmaceutical Co., Ltd., Hunan Xinjinfu Medical Technology Co., Ltd.
2021 Phase II Beijing Medical Device Supervision and Sampling Unqualified Products Summary Table
sample name | Sampling unit | Indicate production unit | Production batch number | judgment result | unqualified items | Remarks | |
1 | Disposable medical masks | Beijing Germany Renkang Pharmaceutical Co., Ltd. | Changchun Hengxiao Biotechnology Co., Ltd. | 20200406 | Unqualified | Technology Requires 2.4.2 mask belt tension, 2.5 bacterial filtration efficiency | District-level sampling |
2 | medical surgical mask (sterile) | Beijing Jianyu Golden Elephant Pharmacy Co., Ltd. | Hunan Kanglilai Medical Equipment Co., Ltd. | unqualified | Technical requirements 2.4.2 Mask belt tension | District-level sampling | 3 | Disposable Medical Mask | Beijing Houde Ankang Octagonal Medicine Co., Ltd. | < span>Guangdong Meishida Pharmaceutical Packaging Materials Co., Ltd. | 20201119 | < p>Unqualified | Technical requirements 2.4.2 Mask belt tension | District Sampling |
4 | Medical surgical masks | Beijing Tainingkang Medicine Co., Ltd. Tancheng Store | Nanchang Yierkang Medical Equipment Co., Ltd. | 20200901 | Unqualified | < span>Technical requirements 2.4 mask belt | District-level sampling |
5 | Medical surgical masks | < p>Majiabao Street, Fengtai District, Beijing Ruili Riverside Community Health Service Station | < p>Guangxi Anran Medical Equipment Co., Ltd. | 2020081502 | Unqualified | Technical Requirements 2.4.2 Mask Belt | District Sampling |
6 | Disposable medical mask (non-sterile) | Dingdang Smart Pharmacy (Beijing) The Fifth Store of Co., Ltd. | Hebei Shian Medical Equipment Co., Ltd. | 20200616 | Unqualified | Technical Requirements 2.4 Mask Belt | District Sampling |
7< /span> | Medical protective masks | Beijing Tianhou Medical Equipment< /span> Co., Ltd. | Xinxiang Dafang Medical Equipment Manufacturing Co., Ltd. p> | 2101021702 | unqualified | Technical Requirements 2.12 Adhesion | District Sampling |
8 | Medical Surgical Mask | Beijing Tianli Yikang Medical Equipment Co., Ltd. | 2020091506 | Technical Requirements 2.4.2 Mask Belt | District Sampling | ||
9 < /td> | Medical surgical masks | Beijing Dongsheng Tianbaotang Pharmacy Chain Co., Ltd. Shuangjing Store | Jiangxi Yuansheng Langhe Pharmaceutical Co., Ltd. < /td> | 20210102 | Unqualified | Technical Requirements 2.4.2 Mask Belt span> | District Sampling |
10 | Medical protective masks | Beijing Beiyi Medicine Co., Ltd. | Hunan Xinjinfu Medical Technology Co., Ltd. | < span>20200404 | Unqualified | Technical Requirements 2.11 Adhesion | District Sampling |