On April 23, 2020 NMPA CMDE (Center of Medical Device Evaluation) issued the review results on green pathway for two innovative medical devices:
- Microtech Medical: Continuous Glucose Monitoring System
- Edwards Lifesciences: Transcatheter Valve Repair Clip
With the purpose of encouraging innovations and seeking breakthroughs of the medical device industry, the NMPA Innovation Approval has paved a fast track for regulatory clearance on eligible medical devices. The granted priority manifests in the classification determination, pre-clinical testing, QMS auditing, and NMPA reviewing/approving processes. Meanwhile, the specially-assigned NMPA officers would check in and provide guidance throughout the whole expedite process.
The NMPA Innovation Approval Guideline was published in November 2018. It states that 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.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------