有源医疗器械注册质量管理体系核查常见问题简析与建议

目的:对在有源医疗器械注册质量管理体系核查中发现的问题进行汇总,以供业内借鉴与参考。方法:对2020年5月~2021年8月在37个有源医疗器械产品注册核查过程中发现的主要问题进行归类分析。结果与结论:有源医疗器械生产企业应按《医疗器械生产质量管理规范》要求,对设计开发、采购、生产管理、质量控制等重要环节进行严格管控,提升质量体系运行能力,以期能持续生产出符合预期用途和技术要求的产品。

Brief Analysis and Suggestion of the Problems Existing in the Inspection of Active Medical Device Registration

Objective:This article makes a summary of existing problems in the inspection of active medical device registration,so as to provide references for the industries.Methods:The problems of registration inspection existed in 37 different active medical device products from May 2020 to August 2021 are classified and analyzed.Results and Conclusion:According to the standards of Good Manufacturing Practice for Medical Devices active medical device enterprises should strictly control the key processes such as design and development,purchasing,production management,quality control.Manufacturing enterprises should promote the effective operation of quality system in order to produce qualified products consistent with intended use and technical requirements.