The National Medical Products Administration (NMPA) has issued the “Medical Device Online Sales Quality Management Norms (draft proposal)” and is soliciting public feedback until October 14. This document outlines the fundamental requirements for quality management in the online sales process of medical devices, ensuring that the burgeoning e-commerce sector adheres to strict quality and safety standards.
Scope and Application of the Draft Proposal
The draft proposal is applicable to all entities involved in the online sales of medical devices, including operators and e-commerce platform operators who facilitate online transactions of such products. It mandates that these operators adhere to the quality and safety management obligations as prescribed by law.
Responsibilities of Network Service Providers
The document also extends its scope to video, live streaming, and online social networking service providers who offer online business venues, transaction matching, and information publishing services for the online sale of medical devices. These network service providers are required to fulfill the medical device quality and safety management obligations of platform operators in accordance with the law.
Ensuring Compliance and Safety
By setting clear guidelines for online sales, the NMPA aims to enhance compliance and safety in the medical device industry. The draft proposal is a step towards regulating the online marketplace, protecting consumers, and maintaining the integrity of medical device distribution channels.-Fineline Info & Tech
