肺炎支原体抗原检测试剂盒(胶体金法)
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英诺特:公司已与京东、天猫、美团等主流电商平台通过开设官方旗舰店等方式建立合作关系
Zheng Quan Ri Bao· 2025-12-11 14:10
(文章来源:证券日报) 证券日报网讯 12月11日,英诺特在互动平台回答投资者提问时表示,公司现有产品中能很好契合居家 检测需求的产品包括"甲型流感病毒、乙型流感病毒、肺炎支原体抗原检测试剂盒(胶体金法)""甲型 流感病毒、乙型流感病毒、新型冠状病毒(2019-nCoV)抗原检测试剂盒(乳胶法)""呼吸道合胞病 毒、腺病毒、偏肺病毒、副流感病毒抗原联合检测试剂盒(乳胶层析法)""A群轮状病毒、腺病毒、诺 如病毒抗原检测试剂盒(乳胶层析法)"、大便隐血(FOB)检测试剂盒(胶体金免疫层析法)、幽门 螺杆菌抗原检测试剂盒(乳胶法)等,目前公司已与京东、天猫、美团等主流电商平台通过开设官方旗 舰店等方式建立合作关系。目前居家检测市场正处于较快的发展时期,随着相关监管制度、诊疗指南的 完善,居家检测产品将具有广阔的应用市场。 ...
国家药监局通报5起典型案例,网销医疗器械监管持续加强
2 1 Shi Ji Jing Ji Bao Dao· 2025-07-23 01:56
Core Viewpoint - The National Medical Products Administration (NMPA) has reported five cases of illegal medical device sales online, highlighting the need for stricter regulation in the rapidly growing e-commerce sector for medical devices [1][3][4]. Summary by Relevant Sections Regulatory Actions - The NMPA has been actively addressing illegal activities in the online medical device market, having reported ten batches of typical cases since 2023, totaling 52 cases [1][4]. - The recent cases involved various e-commerce platforms such as Ele.me, Meituan, JD.com, Tmall, and Xianyu, with violations including unauthorized expansion of business scope and selling unregistered third-class medical devices [1][3]. Market Growth and Challenges - The online medical device market in China has seen explosive growth, with the number of companies engaged in online sales increasing from 8,717 in 2018 to over 360,000 by May 2023 [3]. - This rapid expansion has led to numerous irregularities, necessitating enhanced oversight to ensure public safety and compliance within the industry [3][4]. Compliance and Responsibilities - The NMPA has emphasized the importance of both online sellers and e-commerce platforms adhering to regulatory standards, including the establishment of a quality management system for online sales [6][7]. - E-commerce platforms are required to conduct real-name registration of sellers, implement quality management audits, and establish complaint and reporting mechanisms [7][8]. Future Directions - The NMPA has introduced the "Quality Management Specifications for Online Sales of Medical Devices," which will take effect on October 1, 2025, to further strengthen regulatory compliance [6]. - There is a call for improved collaboration between national and local regulatory bodies, as well as the establishment of a unified reporting channel for violations [5][6].