Since October 1st, 2018, the guideline of "Special Review and Approval Procedure for Innovative Medical Devices (CFDA notice No.13 2014)" has come into force. The guideline, published on May 7th, 2018, focuses on establishing a gradation administration and facilitating the approval process.
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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About China Med Device, LLC
China Med Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD and combination-product companies to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation, clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, distribution qualification and management. We are a NMPA (CFDA) certified legal agent. With offices in Boston and Beijing, we can service our clients 24/7.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------