On December 4,2023,the National Medical Products Administration revised and released the Good Supply Practice for Medical Devices(hereinafter referred to as the GSP),scheduled to be effective from July 1,2024.As an important document guiding quality management and supervision in the medical device operational process,the GSP play a vital role in regulating medical device operations,strengthening quality supervision,promoting the standardization of the industry,and ensuring the safety and efficacy of public medical device use.This article summarizes the core elements of this normative revision,and provides a systematic and process-oriented method.It focuses on the revision's origins,reasons,thoughts,and the content of the GSP clauses related to the core elements.The aim is to provide readers with more systematic and comprehensive information,enhance their understanding of the internal logic behind document revision and drafting,and provide support and assistance for regulatory authorities at all levels in transforming local implementation rules and regulations,as well as for the implementation of medical device operating enterprises.
关键词
质量规范/质量体系/业态创新/质量监管/医疗器械
Key words
quality specifications/quality system/innovation in business formats/quality supervision/medical device
维普
万方数据