关键词: 省级, 医疗器械, 产品注册, 生产许可, 流程管理

Abstract:

Product registration and production license of medical device are important nodes of the whole life cycle management of medical device. Provincial-level medical device product registration and production license interface process， including the business processes on the verification of the third class of medical device registration quality management system and product registration review and production license of the second class of medical device. There is the connection between technical review and quality management system verification. The second and the third categories of medical device product as the focus area of local innovative medical device support， the analyzing and combing product registration and production license interface business processes and regulatory requirements， it is of great significance to promoting the optimization of the linked business process. On the basis of combing the quantity and regional distribution， registration application and production quantity of medical device enterprises， this study summarized the problems and business process analysis in the linking process of product registration and production license of medical devic， and probed into the optimization path and digital improvement strategy of the linking process of product registration and production license， put forward the business process management strategy of provincial medical device product registration and production license， including life cycle management， business process optimization and the department coordination mechanism， etc. ， with a view to promoting the rapid development of the medical device industry and providing guidance and reference for the optimization of the process management of product listing and quality management system verification business.

Key words: Provincial； , Medical device； , Product registration； , Production license； , Process management