Abstract: In order to ensure the effectiveness and safety of the hemodialyzer, this paper summarizes the key contents of the pre-marketing technical review of the hemodialyzer from the aspects of risk administration, technical requirements, process research, evaluation of toxic substances, Quality Control System, etc. according to the latest regulations, national/industrial standard terms, and the latest cognitive level. For the reference of professionals in research and development, production, review, supervision and other related fields.

Key words: Hemodialyzer, Technical review, Effectiveness, Security