Announcement of the National Health Commission and NMPA on the Issuance of Temporary Import and Use Management requirements for Medical Devices in Urgent Need of Clinical Use in Medical Institutions (No. 97 of 2024)

In order to standardize the management of the temporary import and use of medical devices urgently needed by clinical institutions and further meet the urgent needs of clinical diagnosis and treatment, In accordance with the Regulations on the Supervision and Administration of Medical Devices (Decree No. 739 of The State Council), the Measures for the Administration of Registration and Filing of Medical Devices (Decree No. 47 of the State Administration for Market Regulation) and the Measures for the Administration of Registration and Filing of in vitro Diagnostic Reagents (Decree No. 48 of the State Administration for Market Regulation) and other relevant provisions, The NMPA, together with the National Health Commission, formulated the Administrative Requirements for the Temporary Import and Use of Medical Devices in Urgent Need of Clinical Use in Medical Institutions, which are hereby promulgated and shall come into force as of the date of promulgation.

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