The China Food and Drug Administration (CFDA) recently released draft rules proposing a new priority review pathway of premarket submissions for certain medical devices with breakthrough technologies (Proposed Rules). This priority pathway builds upon the State Council’s Opinion on Reform of the Drug and Medical Device Approval System (“Document No. 44”), which was released in August 2015. Document No. 44 is a blueprint for the reform of drug and medical device review procedures and an effort to ensure that CFDA has an efficient procedure for approving medical devices that fill unmet medical needs.
Priority review in this case means that the applicant will have better access to communication channels with the Center for Medical Device Evaluation (CMDE) regarding its application. CMDE conducts technical reviews of device applications and makes recommendations to CFDA for approval. The ability to communicate and meet with CMDE and its reviewers is more difficult under standard review conditions. Therefore, the Proposed Rules provide a significant advantage to applicants. The procedures do not provide for a specific timeline for priority review.
Under the Proposed Rules, CFDA considers a device appropriate for this priority review pathway if it is classified as a Class III domestically manufactured device or a Class II or III imported device and:
- 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);
- The device has orphan or oncology-related indications, and offers a significant clinical advantage over existing products;
- The device can treat or cure diseases that are prevalent among the elderly or children, and no approved alternative treatment exists;
- The device meets an urgent clinical need, and no approved product of the same type exists; or
- CFDA otherwise determines that the device should enjoy priority review status.
To obtain priority review status, the applicant must provide evidence that it meets one of the conditions above. 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 designate the device for priority review.
This is not the first time that CFDA makes expedited review pathways of premarket submissions available for medical devices. Previously in 2014, CFDA put in place a special review procedure for innovative medical devices that allows expedited review of medical devices with certain innovative technologies (“Innovative Device Pathway,” see our prior blog entry, here). While this new proposed priority review pathway shares many procedural characteristics with the innovative device pathway, the two procedures have different scopes. CFDA also has a review procedure for emergency devices needed to deal with, for example, medical care if there is a natural disaster or other mass incident.
CFDA has clarified in the Proposed Rules that if a device has already been accepted to the innovative device or emergency device review pathway, the device is not eligible for this new priority review procedure.
Medical device manufacturers should continue to monitor this development and explore the best available premarket submissions pathways for marketing medical devices in China.