This article reviews and summarizes the regulatory requirements and recent research progress by major global medical device regulatory agencies and organizations regarding the point-of-care manufacturing of medical devices.It analyzes the risks and feasibility of implementing a comprehensive regulatory model,a specialized regulatory model,and a medical device production system regulatory model in China.This study aims to provide a reference for developing regulatory frameworks for the point-of-care manufacturing of medical devices in China.
关键词
医疗机构/医疗器械/医疗机构内生产/监管模式
Key words
healthcare facility/medical devices/point-of-care manufacturing/regulatory model
维普
万方数据