21世纪经济报道记者闫硕北京报道 近日，国家药监局通报5起医疗器械网络销售违法违规案件信息，严厉打击违法违规行为。 记者梳理5起典型案件发现，相关违法违规行为出现在各类电商平台，包括饿了么、美团、京东、天 猫、闲鱼等；违法违规类型则包含擅自扩大经营范围、销售说明书和标签不符合规定的医疗器械、未经 许可销售第三类医疗器械、擅自变更经营场所等多种类型。 这并非国家药监局首次通报医疗器械网络销售违法违规案例。近些年，随着电子商务的发展和医疗行业 的数字化转型，医疗器械电商行业快速发展，但同时也催生了一些乱象。为保障公众用械安全，各级药 监部门积极查处企业违法违规行为。自2023年以来，国家药监局已先后通报10批典型案例。 上海德禾翰通律师事务所律师张晓欣向21世纪经济报道记者表示，我国的医疗器械按照一二三类进行分 类管理，其中经营第三类医疗器械实行许可管理，经营第二类医疗器械实行备案管理，经营第一类医疗 器械不需要许可和备案。当前医疗器械电商行业存在一些乱象，主要原因是监管没跟上，以及平台的主 体责任没有落实到位。但随着监管加码，平台的合规意识和能力加强，网上医疗器械的销售乱象会得到 有效遏制。 值得一提的是，通报 ...

Policy Developments - The National Medical Products Administration (NMPA) reported five cases of illegal online sales of medical devices, including companies selling products without proper licenses and failing to meet regulatory requirements [2] Drug and Device Approvals - East China Pharmaceutical's subsidiary received approval for clinical trials of HDM2012, a novel antibody-drug conjugate targeting mucin-17, marking it as a global first-class biological product [3] - Novo Nordisk announced that the NMPA approved the new indication for Ozempic (semaglutide injection) for chronic kidney disease, making it the first GLP-1 receptor agonist approved for this use in China [4] - Wanfu Bio received a medical device registration certificate for its MSI detection kit, which is significant for various solid tumor patients [5] Financial Reports - Fuan Pharmaceutical projected a net profit decline of 39.95% to 53.81% for the first half of 2025, primarily due to price reductions from national procurement policies [6] Capital Market Activities - Kanghua Bio announced a transfer of shares that will change its controlling shareholder to Wanke Xin Bio, with a total transfer price of approximately 1.85 billion yuan [8] - Jichuan Pharmaceutical's stock will resume trading after a tender offer by Cao Fei, who will control 56.07% of the company post-offer [9] Industry Developments - A new oral antiviral drug for influenza, Marselevosavir, developed by Zhengxiang Pharmaceutical, has been approved for use in treating uncomplicated influenza in previously healthy adults [10] Public Opinion Alerts - Notai Bio is facing other risk warnings due to a prior administrative penalty for false reporting, which included inflating revenue and profits [11]

国家药监局组织召开加强医疗器械网络销售重点产品监测和处置工作调度会。会议通报医疗器械网络销 售重点产品监测处置工作情况，听取北京、上海、浙江、贵州等地医疗器械网络销售监管工作情况，对 进一步加强医疗器械网络销售监管重点进行部署。会议强调，在全面推进网络销售监管的基础上，聚焦 群众和社会关切，强化重点产品监管。坚持线上违法线索和线下违法行为一体查处，坚持网络监测、检 查、抽检、处罚相结合，坚持依法履职、协同治理、闭环处置原则，有效保障公众网购用械安全。 ...

Policy Developments - The National Medical Products Administration (NMPA) has announced the implementation of the "Quality Management Standards for Online Sales of Medical Devices," effective from October 1, 2025. Regulatory authorities are required to guide online sellers and e-commerce platforms in conducting internal training and assessments related to quality management systems, product information display, and risk monitoring [2]. Drug and Device Approvals - BeiGene announced positive results from the Phase 2 clinical trial (DeLLphi-307) of tarlatamab for treating extensive-stage small cell lung cancer (ES-SCLC) patients in China, with detailed data to be presented at an upcoming medical conference [4]. Capital Market Activities - Shanghai BoYin Biotechnology Co., Ltd. has completed a multi-million angel round financing, led by Zhangjiang Life and Health Industry Incubation Angel Fund, with funds aimed at advancing the company's product pipeline and early clinical validation of its first product [7]. Industry Developments - Yuheng Pharmaceutical has signed a co-promotion agreement with Xinghe Pharmaceutical for Pemafibrate, a novel selective PPARα modulator, which will take effect on June 1, 2025. This agreement is expected to enhance Yuheng's product pipeline and potential profit growth, although it will face competition from established products [9]. Shareholder Activities - Chengdu XianDao announced that shareholder Anji Dongfang Jiayu Enterprise Management Partnership reduced its stake by 1 million shares, decreasing its ownership from 6.2% to 5.95% [12]. - BioVeda China RMB Investment Limited plans to reduce its stake in AoJing Medical by up to 135,550 shares, having already reduced its holdings by 34,510 shares, representing 0.25% of the total shares [13].

Core Viewpoint - The National Medical Products Administration (NMPA) has released the "Quality Management Specification for Online Sales of Medical Devices," aimed at regulating the rapidly growing online medical device sales market in China, which has seen a significant increase in the number of companies involved in this sector [1][2]. Group 1: Background and Market Growth - The online medical device sales market in China has experienced explosive growth, with the number of companies engaged in online sales rising from 8,717 in 2018 to over 360,000 currently, and third-party platform companies increasing from 77 to 851 [1]. - The NMPA has incorporated relevant regulations into the newly revised "Regulations on the Supervision and Administration of Medical Devices" to promote a healthy and orderly development of the online medical device sales market [1]. Group 2: Key Components of the Specification - The "Specification" consists of four chapters and fifty articles, covering general principles, quality management for online sales operators, quality management for e-commerce platform operators, and supplementary provisions [1]. - It requires online sales operators and e-commerce platforms to establish and maintain a quality management system suitable for online medical device sales and ensure its effective operation [1][2]. Group 3: Responsibilities and Requirements - The specification emphasizes the responsibilities of online sales operators in building a quality management system, enhancing risk management, and ensuring compliance with existing regulations [3]. - Specific public disclosure requirements for companies with medical device operating licenses or registrations are outlined, including the need to display relevant certificates and licenses prominently [3]. Group 4: E-commerce Platform Management - The specification details the management responsibilities of e-commerce platform operators, including the establishment of a quality safety management system and the appointment of qualified personnel [4]. - E-commerce platforms are required to implement a system for identifying and addressing illegal activities related to online medical device sales, including reporting violations to regulatory authorities [5][6]. Group 5: Risk Management and Monitoring - The specification guides e-commerce platforms to enhance internal risk monitoring and collect external risk information to strengthen quality safety risk management [6][7]. - It mandates that key personnel, including the legal representative of the e-commerce platform, conduct quarterly reviews of quality safety risks associated with online medical device sales [7].

国家药监局今天发布《医疗器械网络销售质量管理规范》政策解读，对《规范》出台的背景、总体思 路、主要内容、销售有特殊验配要求医疗器械的要求、网络销售经营者的责任、经营主体信息公示要 求、电商平台经营者的人员配置和机构设置方面的要求，以及违法违规处置和安全风险管理等方面，向 公众做出详细说明。近年来，我国医疗器械网络销售市场迎来爆发式增长。据统计，从2018年至今，从 事网络销售的医疗器械经营企业由8717家增至36万余家，第三方平台企业由77家增长至851家。(央视新 闻) ...

据介绍，近年来，我国医疗器械网络销售市场迎来爆发式增长。从2018年至今，从事网络销售的医疗器 械经营企业由8717家增至36万余家，第三方平台企业由77家增长至851家。 《规范》指导电商平台经营者通过加强内部风险监测和收集分析外部风险信息等方式，持续加强医疗器 械质量安全风险管理，并为企业规划了持续加强医疗器械质量安全风险管理的路径和关键指标。 《规范》共四章五十条，分为总则、网络销售经营者质量管理、电商平台经营者质量管理和附则。《规 范》提出，网络销售经营者和电商平台经营者应当按照本规范要求，建立健全与网络销售医疗器械相适 应的质量管理体系并保证其有效运行。 《规范》进一步细化、压实电商平台经营者管理责任。一是明确电商平台经营者质量安全管理责任。对 入网的网络销售经营者进行实名登记，电商平台经营者要审查其医疗器械相关许可、备案等情况和网络 销售医疗器械产品注册、备案情况，采取有效措施对平台内医疗器械经营者的经营行为进行管理。二是 指导电商平台经营者建立健全质量管理体系。明确电商平台经营者质量管理机构与人员的职责、细化了 网络交易系统功能、健全了覆盖医疗器械网络交易服务全过程的体系文件，指导电商平台经营者 ...