On April 23, 2020 NMPA CMDE (Center of Medical Device Evaluation) granted two innovative medical device status:
- Microtech Medical: Continuous Glucose Monitoring System
- Edwards Lifesciences: Transcatheter Valve Repair Clip
NMPA utilizes fast-track approval pathway for medical devices with innovative status. 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 expedited 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.
For an English copy of Innovation Approval guideline, please email info@ChinaMedDevice.com.
For review of 2019 fast-track channels, please click HERE.
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About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.