关键词: 医疗器械, 可重复使用, 再处理, 监管

Abstract: Objective： To study FDA′s regulatory ideas and procedures for reusable medical devices and to provide reference for future development of relevant process in China. Methods： FDA′s regulatory policies for pre-market and post-market process of reusable medical devices have been colletcted and studied. Relevant publications will also be covered. The concept and classification of reusable medical devices， experience and requirements of FDA on the supervision of reusable medical devices have been summarized. Results and Conclusion： It is much expected that our regulatory authority have definitive requirements in place to enforce supervision on such devices to ensure the safety and efficacy. It should include following details： product scope of reusable medical devices， guidance of validation requirements for cleaning， disinfection， and sterilization of such devices， standardization of product manuals， emphasis on standard operations of usage， cleaning， disinfection and sterilization of such products and emphasis on thorough record keeping， requirement of prompt report of adverse events from manufacturers.

Key words: Medical devices； , Reusable； , Reprocessing； , Supervision