On May 7, 2018, China Food and Drug Administration (CFDA) published a draft guideline "Special Review and Approval Procedure for Innovative Medical Devices (CFDA notice No.13 2014)". The proposed guideline focuses on establishing a gradation administration and facilitating the approval process. 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, Chinese government has paved a fast track for regulatory clearance on eligible foreign medical devices. The granted priority manifests in classification determining, pre-clinical testing, QMS auditing, and CFDA reviewing/approving. Meanwhile, a specially-assigned CFDA officer would check in providing guidance throughout the whole expedite process.
The qualified products shall meet the following simultaneously,
· Class II / Class III Medical Device with significant clinical application value
· Own valid invention patents
· Have China PTO coverage
· Complete the preliminary study on prototype with traceable data
· An authorized in-country legal entity
For English version of the draft guideline, please email info@ChinaMedDevice.com
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China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. We have an office in Beijing, Suzhou and Boston.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------