It is hereby notified that CFDA has organized to develop and issue the Technical Reviews Guidelines for Registration of Disposable Hemodialysis Pipelines (See Appendix) to enhance the surveillance and guidance on product registration of medical devices and further improve the quality of registration review.

Appendix: Technical Reviews Guidelines for Registration of Disposable Hemodialysis Pipelines

China Food and Drug Administration

November 2, 2016

Technical Reviews Guidelines for Registration of Disposable Hemodialysis Pipelines

The Guidelines is intended to guide registration applicants to prepare and compose registration and reporting materials for disposable hemodialysis pipelines (hereinafter referred as hemodialysis pipelines) and also provide technical review departments with registration and reporting materials.

The Guidelines is the general requirements for hemodialysis pipelines. The applicants shall determine whether it is applicable to the product based on its specific characteristics. If not applicable, the applicants shall expound the reason and provide scientific evidence accordingly, and shall replenish and detail the content of registration and reporting materials based on the characteristics of specific products.

The Guidelines provides reference to applicants and reviewers, which cover no administrative matters associated with registration and review and will not be enforced as laws and regulations. Any other methods complying with relevant laws and regulations may also be available, provided that detailed research data and validation data are supplied. The Guidelines shall be implemented in compliance with relevant laws and regulations.

The Guidelines are prepared based on current laws, regulations, standard systems and cognition levels, which may be modified from time to time with the improvement of laws, regulations and standards, as well as the progress of scientific technologies.