Research on the Regulatory Model for Point-of-Care Manufacturing of Medical Devices
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.
healthcare facilitymedical devicespoint-of-care manufacturingregulatory model
万方数据
维普
