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Policy Interpretation —— How to Enter the “Fast Track” of Priority Approval?

from CIRS by

Policy Interpretation – How to Enter the "Fast Track" of Priority Approval?

——This policy was implemented on January 1, 2017


1. Scope of priority approval

  • Projects those are applicable to the priority approval of "fast track"

a. Applications for registration of domestic Class III medical devices.

b. Applications for registration of imported Class II and Class III medical devices.

  • Projects those are not applicable to the "fast track" of Priority Approval

a. Filing of Class I medical devices;

b. Applications for registration renewal and registration change;

c. Applications that have been included in the approval process in accordance with the emergency approval procedures for medical devices or the special approval procedures for innovative medical devices.


2. The conditions for applying for priority approval

(1) Diagnose or treat rare diseases, with obvious clinical advantages.

(2) Diagnose or treat malignant tumors, with obvious clinical advantages.

(3) Diagnose or treat specific and multiple diseases to the elderly, and there are currently no effective diagnoses or treatments.

(4) Dedicated to children, with obvious clinical advantages.

(5) Clinically urgently needed, and for which there are no registered medical devices of the same species in China.

(6) Medical devices listed in major national science and technology projects or national key research and development programs.

(7) Other medical devices that should be prioritized for approval, shall be determined by NMPA after extensively soliciting of opinions and organizing experts to demonstrate.


3. When is the priority approval application submitted?

Those who meet the above priority approval conditions shall submit the application for priority approval together with the registration application for medical devices.


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