Application of Medical Device NMPA Registration
In China, regulatory requirements for medical devices are detailed in Regulations for the Supervision and Administration of Medical Devices, while the regulatory authority is the National Medical Products Administration (NMPA). According to the Administrative Measures for Medical Device Registration and Filing issued by the NMPA, for the medical devices are sold and used in the People’s Republic of China, Class I medical devices are subjected to product filing management, and Class II and Class III medical devices are subjected to product registration management.

Our Services：
Application strategy consulting Develop application solution Obtain the Medical Device Production License* Compile the Product Technical Requirements Communicate with medical device testing center on your behalf Compile registration dossier for your product Communicate with the NMPA on your behalf Obtain the Medical Device Business License Legal Agent service** * This service is only applicable to manufacturers located in China ** This service is only applicable to manufacturers located outside of China