Medical Device NMPA(CFDA) Registration

Legal basis

• 1
  Regulations on supervision and administration of Medical Devices
• 2
  Measures for the administration of registration and filing of medical devices
• 3
  Announcement on the requirement of application materials for registration of in vitro diagnostic reagents and the format of approval documents
• 4
  Announcement on the requirements for registration and application of medical devices and the format of approval documents

Medical device NMPA(CFDA) Registration Process 

Information required

Registration information requirements and instructions for medical device

The registration information shall be submitted to the catalog, including the primary and secondary title . The documents of each secondary title should be compiled separately.