On November 5, 2018, NMPA (CFDA) published final guideline "Special Review and Approval Procedure for Innovative Medical Devices" per CFDA notice No.13 2014. The guideline focuses on establishing a gradation administration and facilitating the approval process. The guideline states that this new rule is coming into force on December 1, 2018.
Summary of CFDA Innovation Approval Guideline
With the purpose of encouraging innovations and seeking breakthroughs of the medical device industry, this CFDA Innovation Approval 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.
Qualification For the Special Review and Approval Procedure
The CFDA Innovation Approval 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:
- 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, and
- An authorized in-country legal entity.
Follow-up
For English version of the guideline, please email info@ChinaMedDevice.com.
Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx 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.
------------------------------
Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------