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Medical Device Industry Dynamics: encouraging innovation as the key to review and approval system reform
Oct 10, 2017

Encourage and support the innovation of domestic medical devices is still the future

In February 2014, CFDA released the special approval procedure for innovative medical devices (trial) (2014]13), which sets up special approval channels for innovative medical devices. In August this year, the State Council's comments on the reform and approval system for the review of drug and medical devices have again pointed out that CFDA has adopted special approval procedures for innovative medical devices, giving priority to applications for registration of innovative medical devices with a patented product core technology and a significant clinical value. The meeting again clearly to continue to encourage medical device innovation, to further improve the working mechanism, enrich the team of experts, closely follow the forefront of science and technology, improve the level of innovation product review and approval.

Since the implementation of the special vetting process in 2014, a total of 40 innovative medical device products have entered the rapid approval channel, the vast majority of which are domestic medical devices. The State supports the development of domestic medical device industry, gives the policy support to the innovation and approval, accelerates the examination and approval procedure, encourages the research and innovation of medical devices, promotes the popularization and application of new technology of medical devices, and facilitates the development of innovative medical devices.