CFDA Announces Second Accelerated Review Pathway for Breakthrough Devices 

The China Food and Drug Administration (CFDA) released draft rules in June 2016 proposing a priority review pathway for certain medical devices. In 2014, the CFDA released an expedited pathway for “innovative” devices, which is similar to but different from this “breakthrough” pathway. Applicants with devices approved in the new pathway will receive extra assistance to streamline the regulatory application process. Most notably, there will no longer be a lengthy pre-qualification to be granted priority review status.  New devices seeking approval must meet requirements that fall into one of three categories determined by the CFDA.

These categories are:

1) devices listed on the “Scientific and Technology Major Projects” or “Key Research & Development Plans”

2) devices treating unmet clinical needs such as orphan diseases, cancer, pediatrics, geriatrics, or other unmet clinical needs

3) other devices deemed appropriate by the CFDA

Once submitted, the Center for Medical Device Evaluation (CMDE), which reviews medical devices and makes recommendations to the CFDA for approval, has five business days to designate the device for priority review. This status allows the applicant to engage in better communication with the CMDE. Priority review medical devices have a significant advantage over devices undergoing the standard review timeline because communication with the CMDE is much more difficult under typical conditions.