Medical devices in China can be divided into three categories according to the level of its own risks, that is, Class I, Class II and Class III. Product belongs to different levels should either be filed or registered in accordance with the registration law made by NMPA. Therefore, it is crucial to define which level the medical device belongs to before registration application.

Medical devices in China can be divided into three categories according to the level of its risks, that is, Level I, Level II and Level III. Product belongs to different levels should either be filed or registered in accordance with the registration law made by NMPA. Therefore, it is crucial to define which level the medical device belongs to before registration.

In-vitro reagents hereby refers to the ones managed as medical devices, include IVD kits, calibrators and quality control materials either to be used alone or in combination with any instrument, apparatus, appliance and software. It is intended to detect body samples, such as all kinds of body fluids, cells, tissue samples in order to diagnose, monitor, prevent diseases from happening, evaluate health condition and predict hereditary diseases.

Definition of Innovative Medical Device：brand-new products emerged in domestic market or safety, effectiveness and functional mechanism haven't been proved yet.

Applicant needs to submit supporting documentations to confirm the product category if classification cannot be specifically defined before starting the formal registration declaration according to Chinese regulations.