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NMPA Issued Three Guidelines for Technical Review of the Registration of Embryo Replacement Catheter in Assisted Reproduction and Others

Updated: 2019-11-01

     

To strengthen the supervision and guidance over the registration of medical device products and further improve the quality of registration review, NMPA has organized the formulation of and released on November 1, 2019 the Guidelines for Technical Review of the Registration of Embryo Replacement Catheter in Assisted Reproduction, Guidelines for Technical Review of the Registration of Methods for the Determination and Identification of Known Leachables in Medical Devices, and the Guidelines for Technical Review of the Registration and Application of Cardiopulmonary Bypass System Extracorporeal Circulation Tubes.