China Food and Drug Administration (CFDA) recently announced that a ‘Priority Review and Approval Procedure for medical devices will come into force from January 1, 2017.
The new pathway is based upon a set of draft rules released by the CFDA in August 2016 (Proposed Rules). As per these rules, certain medical devices are eligible to request for a ‘Priority’ review status if they meet one or more of the following conditions:
1. The device is listed on the “Scientific and Technology Major Projects” or “Key Research & Development Plans” (i.e., two nationwide initiatives that China launched in recent years to promote innovation and technological advancement);
2. The device has oncology-related indications, and offers a significant advantage over existing technologies;
3. The device is used in the diagnosis/treatment of rare diseases, and offers a a significant advantage over existing technologies;
4. The device is used in the diagnosis/treatment of diseases affecting children and the elderly, for which no approved alternative exists;
5. The device answers an unmet clinical need, for which no approved alternative exists; or
6. CFDA otherwise determines that the device should be granted a priority review status.
Currently, all Class III devices (imported or domestically manufactured) are qualified to request for this status. But, for Class II devices, this pathway is restricted to only ‘imported’ devices.
Center for Medical Device Evaluation (CMDE) will make an initial determination of eligibility and publish a list of medical devices that it is considering for priority review. If no objections are raised in 5 business days, CMDE will finalize the designation.
The expedited review status presents several advantages to applicants, including frequent communication with the review team and prioritized technical evaluation.
CFDA has previously implemented a fast-track approval procedure for innovative medical devices, also known as the ‘Green Channel’ and an accelerated approval process for emergency-use devices.
We at Global Regulatory Partners believe that medical device/IVD companies doing business in China should monitor the implementation of these innovative pathways, as it can be highly valuable in the long run.
For a detailed overview on Special Approval Procedures on Medical Devices in China, please click here.