On May 7, 2018, China Food and Drug Administration (CFDA) published a draft guideline “Special Review and Approval Procedure for Innovative Medical Devices” per CFDA notice No.13 2014. The proposed guideline focuses on establishing a gradation administration and facilitating the approval process. Furthermore, the guideline states that this new rule is coming into force on October 1, 2018.
With the purpose of encouraging innovations and seeking breakthroughs of the medical device industry, this CFDA Innovation Approval Draft Guideline has paved a fast track for regulatory clearance on eligible foreign medical devices. In addition, the granted priority manifests in the classification determination, pre-clinical testing, QMS auditing, and CFDA reviewing/approving processes. Meanwhile, a specially-assigned CFDA officer would check in and provide guidance throughout the whole expedite process.
The CFDA Innovation Approval Draft Guideline further states that your medical device and IVD product must meet all of the following criteria to qualify for the special review and approval procedure:
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