On September 2018, we, the National Medical Products Administration, issued the Notice on the Publication of Revised Catalogue of Medical Devices Exempted from Clinical Trials ([2018] No. 94), covering 855 medical device products and 393 in vitro diagnostic reagent products. On December 2019, we issued the Notice on the Publication of New and Revised Catalogue of Medical Devices Exempted from Clinical Trials ([2019] No. 91). Additional 148 medical device products and 23 in vitro diagnostic reagent products are added, and the names and descriptions of 48 medical device products and 4 in vitro diagnostic reagent products are revised.
For the convenience of inquiry, the catalogues of medical devices exempted from clinical trials and in vitro diagnostic reagents exempted from clinical trials are hereby summarized.
For original text and document, please refer to original Chinese website
For the convenience of inquiry, the catalogues of medical devices exempted from clinical trials and in vitro diagnostic reagents exempted from clinical trials are hereby summarized.
For original text and document, please refer to original Chinese website