医疗器械注册质量管理体系核查中真实性核查方法的探讨

Discussion on the Authenticity Verification Method in the Verification of Medical Device Registration Quality Management System

摘要: 真实性核查是医疗器械注册质量管理体系核查中很重要的一个方面。如何对样品的真实性进行核查是一个值得探讨的问题。该研究从产品留样、注册检验报告、记录的追溯性、硬件设施设备等方面分析了真实性核查的方法，以期对相关监管人员和检查员在注册质量管理体系核查时提供参考。

Abstract: Authenticity verification is a very important aspect of medical device registration quality management system verification of medical device. How to verify the authenticity of samples is a problem worth discussing. This study analyzes the methods of authenticity verification from the aspects of product retention sample, registration inspection report, traceability of records, hardware facilities and equipment. In order to provide reference for relevant supervisors and inspectors in the verification of registration quality management system.