关键词: font-size:medium, ">医疗器械GMP；QSR820；ISO13485；医疗器械GMP现场检查指导原则

Abstract: Objective： Medical Device Good Manufacturing Practice (Medical Device GMP) is the basic criterion for the products manufacturing and quality management of medical device manufacturers. It is also the legal basis of market allowance and daily supervision and inspection. The medical device GMP aims to strengthen the medical device quality management， strictly control the manufacturing process to reduce related risks and to ensure the safety and performance of medical devices， as well as to promote medical devices manufacturing developing. China′s Medical Device GMP which published in 2014 achieves international level both in width and depth， which agree with the requirements specified in U.S. QSR820 and ISO13485， marking China′s Medical Device GMP marched the international stage from then. This article sorted the formulation and development background of China′s Medical Device GMP， U.S. QSR820 and ISO13485， and discussed from the following 4 aspects： basic management concept， basic execution requirements， management review process and process control in the major quality system operation， on the internationalization of Medical Device GMP in China， and also specified the requirements with Chinese characteristics and suggestions on establishing quality management system from medical device manufactures.
   

Key words: font-size:medium, ">Medical Device GMP； QSR820； ISO13485； Guidance on Chinese Medical Device GMP On-site Audit