[Study on situations of review and pre-evaluation for medical device product specification in China]

This paper researched on course of registration and administrative licensing for medical device product specification, analyzed the existing demands of review and pre-evaluation, discussed about how to improve and manage pre-evaluation results for testing laboratory and manufacturer in China, based on "Provision of Medical Device Product Specification Standardization", "Provision on Medical Device Registration" and relative documents of States Food & Drug Administration. It suggested that set up and maintain a professional team of review and approval staff, further strengthen standardization of medical device specification, arming at current situations of non-compatibility between documents and inconformity of performance in different provinces. It paid attention to control the quality of medical device to ensure the core of safety and effectiveness for using medical device.