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].
压实电商平台经营者对医疗器械网络销售质量管理责任 政策解读→
Yang Shi Xin Wen·2025-05-09 15:14