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NMPA is paying more and more attention to clinical trial authenticity audit in IVD as well. Just want to share critical guidelines so that you are aware of what to follow and how to stay compliant for your valuable clinical trial results and efforts. To ensure compliance with NMPA's evolving requirements ...

China currently has 1,380 healthcare institutions authorized to conduct clinical trials, in accordance with the "Quality Management Practice Specification for Clinical Trials of Medical Devices" (known as China GCP) implemented since March 2022. These are for regulatory approval trials qualified institutions. ...

On March 19, 2024, the National Medical Products Administration (NMPA) released its latest guideline titled "Medical Devices Usability Engineering Guideline." The guideline aims to enhance the usability and design of medical devices to minimize potential usage errors and the associated harm, thus enabling ...

The National Medical Products Administration (NMPA) recently issued "Clinical Pathway Recommendations for Certain Categories of Medical Devices," aimed to simplify market access for surgical equipment in cardiac, neuro, ortho, medical aesthetic, and dental surgery etc. These recommendations, based ...

China National Medical Products Administration (NMPA) has released draft regulations outlining how it will inspect medical device clinical trial institutions in China. The measures aim to ensure compliance with Good Clinical Practice (GCP) standards for medical devices and in vitro diagnostics (IVDs). ...