To further implement the opinion of State Council on reformation of examination and approval system for drug medical device and ensure the clinical use demand on medical device, CFDA, by in-depth research and extensive collection of advices, issued Priority Approval Procedure for Medical Devices recently and such document will come into force on January 1, 2017.

CFDA gives priorities to approve the following medical devices as per the procedure: 1. the medical devices with obvious clinical advantages and for diagnosis or treatment of rare disease, malignant tumor, the devices for diagnosis or treatment of specific and multiple diseases to the old without effective diagnosis or treatment method, children-specific devices with obvious clinical advantages, clinically urgently required devices without same kind of product registration approved in China; 2. the medical devices listed in national key S&T Special Projects or national key R&D plan. In addition, CFDA will, based on various conditions and opinions, perform priority approval for “other medical devices should be approved with priority” upon specialist examination.

For projects with definite priority of approval, CFDA will speed up the examination and approval throughout the link, offering priority to the technical examination, medical device registration quality management system verification, administrative examination and approval, shortening the time to market so as to ensure soon clinical application of relevant outcomes and products.

The release of the procedure is the embodiment of the implementation of the requirement from the State Council on transformation of government function and promotion of “delegate power, improve regulation and optimize services” work. It will further promote the development of the medical device industry in China and drive the products in clinically urgent need to be market available and improve the people’s health level.