NMPA Releases New and Revised Catalogues of Medical Devices and IVD Reagents Exempt from Clinical Trials

In December 2019, the NMPA issued the Announcement on the Publication of New and Revised Catalogs of Medical Devices Exempted from Clinical Trials (No. 91 of 2019).

In order to implement the opinions of the General Office of the State Council on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices, the State Council's requirements for deepening the reform, and further improving the management of medical device registration, the NMPA has formulated new and revised catalogs for medical devices and IVD reagents that are exempt from clinical trials in accordance with the Medical Device Supervision and Administration Regulations , the Measures for the Administration of Medical Device Registration , and the Measures for the Administration of Registration of In Vitro Diagnostic Reagents .

The new catalog added 148 medical device products and 23 in vitro diagnostic reagents products, and revised the names and descriptions of 48 medical device products and 4 in vitro diagnostic reagent products.