Regulatory Open Forum

 View Only

China NMPA Issued a Microstent Technical Review Report

  • 1.  China NMPA Issued a Microstent Technical Review Report

    Posted 11 days ago

    The NMPA CMDE recently issued a comprehensive technical review report, marking the fifth such report for overseas manufacturers this year. These reports are valuable resources for understanding NMPA technical and clinical reviewers' perspectives and evaluation criteria. They offer insights into various aspects, including product structure, intended use, pre-clinical studies, biocompatibility, animal studies, and clinical evaluations etc. 

    For instance, the microstent is designed for patients with open-angle glaucoma who may not benefit from traditional surgeries or medications alone. The product underwent rigorous evaluations, including biocompatibility assessments and animal studies, demonstrating its safety and efficacy. 

    The applicant conducted the clinical evaluation by submitting overseas clinical trials data. The Clinical trials showed promising results, with the experimental group exhibiting significant reductions in intraocular pressure compared to the control group. Long-term follow-up data further supported the product's effectiveness in maintaining reduced intraocular pressure levels. 

    Please feel free to reach out if you want to know if NMPA released review reports for your device or you need a English copy of this report. 



    ------------------------------
    Grace Fu
    China Med Device, LLC
    gpalma@ChinaMedDevice.com
    Phone US: (978) 390-4453
    Phone China: 18201749732
    www.ChinaMedDevice.com
    ------------------------------