All companies planning to sell or distribute a medical device or IVD in China must register their product with the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration or CFDA. The NMPA reviews all device applications, and has strict requirements for submission documentation, testing, and clinical data. Medical devices are classified based on NMPA Order 15 and the NMPA classification database. Class I devices need to submit applications with a technical dossier including detailed technical information, clinical data, and quality documentation to the NMPA. For Class II and III devices an additional on-the-spot testing in accredited laboratories in China is required. STEMart can help you obtain regulatory approval for your medical device or IVD in China.