Chinese NMPA Regulatory Approval Process for Medical and IVD Devices

To see their products in the Chinese market, medical and in vitro diagnostic (IVD) device manufacturers will need to obtain National Medical Products Administration (NMPA) approval.  

The Chinese NMPA medical device approval process explained 

The chart illustrates the NMPA approval process per device classification in China and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here. 

Step 1 
Determine the classification of your device according to the NMPA’s classification catalogs and determine the appropriate clinical evaluation route according to the NMPA’s criteria.  

Step 2 
Appoint an agent located in China to manage your device registration and interact with the NMPA on your behalf. 

Step 3 
Demonstrate proof of home country approval using documentation such as a Certificate of Free Sale (CFS) or Certificate to Foreign Government (CFG). 

Step 4 
Prepare the Product Technical Requirement (PTR) document and complete the required device testing according to the applicable Chinese standards.  

Step 5 
Prepare a registration/notification dossier for submission to the NMPA.  

Step 6 
Pay the application fee. The NMPA reviews the application and may request additional information. For higher-class devices, they also reserve the right to perform an inspection of the manufacturer’s quality management system (QMS) for compliance with the NMPA’s Good Manufacturing Practices (GMP) regulation, although this is not common in practice. 

Step 7 
Upon approval, the NMPA issues the notification of filing number or registration certificate as applicable.