Yes, China's National Medical Products Administration (NMPA) may accept US FDA approval as a reference for the registration of medical devices and diagnostics in China. Like the acceptance of CE marking approval, the acceptance of US FDA approval as a reference depends on several factors, including the classification of the device, its intended use, and the specific requirements of the NMPA.
Having US FDA approval may demonstrate compliance with certain international standards and requirements, which could potentially streamline the registration process in China. However, the NMPA may still require additional testing, documentation, or other requirements before granting registration in China.
It is advisable to consult with regulatory experts familiar with the NMPA regulations and requirements to determine the specific implications of US FDA approval for the registration of medical devices and diagnostics in China.
