Good Clinical Practice for Medical Devices

On 2 April 2022 the Chinese NMPA issued an announcement for the GMP for clinical trials of medical devices (No. 28 of 2022).

According to the "Regulations on the Supervision and Administration of Medical Devices" (Order No. 739 of the State Council) and the "Administrative Measures for Registration and Filing of Medical Devices" (Order No. 47 of the State Administration for Market Regulation), "Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents" (Order No. 48 of the State Administration for Market Regulation), the NMPA, in conjunction with the National Health Commission, organized the revision of the "Good Clinical Practices for Medical Devices", which are hereby promulgated and effective May 1, 2022.

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