Recently overhauled CFDA regulations place an emphasis on ‘fast-track’ approval channel for medical devices.
In February 2014, the China Food and Drug Administration released Trial Procedures for the Special Examination of Innovative Medical Devices (Special Procedures).
Under these special procedures, if a medical device meets certain criteria it will be eligible for “priority” evaluation and approval procedures.
Other than this ‘Innovative device’ pathway, The CFDA recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies.
While this new proposed priority review pathway shares many procedural characteristics with the innovative device pathway, the two procedures have different scopes.
Both domestic and foreign applicants are eligible for these programs. Several imported medical devices/IVD’s have already been accepted into these fast-track programs.
Global Regulatory Partners can assist you in the development of a robust regulatory strategy for your medical device/IVD in China that is optimized and in compliance with the latest CFDA updates.
For a detailed overview on Special Approval Procedures for Innovative Medical Devices, please click here.