Announcement on Pilot Application of Electronic Registration Certificate for Medical Devices

  • 2020-10-19
In order to implement the decisions and deployments of the State Council on deepening the reform of streamlining administration, delegating powers and improving administration and services, optimizing the business climate, promoting the decisions and deployments of "Internet + Government Services", and to provide companies with more efficient and convenient government services, it has been decided that the electronic registration certificate of medical devices will be piloted from October 19, 2020. The relevant matters are hereby announced as follows:
I. The pilot period is from October 19, 2020 to August 31, 2021.
II. The piloted certificates include the newly approved registration certificate for the domestic Category III medical devices as well as the registration certificates for the imported Categories II and III medical devices that are registered for the first time as of announcement. Changed and extended registration certificates will be issued gradually as appropriate.
III. During the pilot period, the electronic the paper registration certificates of the medical device will be issued simultaneously. The electronic medical device registration certificate has the same legal effect as the paper medical device registration certificate.
IV. No technical requirement of the product is covered in the medical device electronic registration certificate.
V. The companies shall first register and verify their real names in the ehall of the National Medical Products Administration before they can go to the column of "My License" in the ehall to check and download the electronic registration certificate of the medical device. Besides, the companies can also log in to the “NMPA APP" to check the electronic registration certificate of the medical device.

National Medical Products Administration
October 16, 2020