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China NMPA Issued Guideline of Drug-Coated Balloon Dilation Catheter Asking for Feedback

  • 1.  China NMPA Issued Guideline of Drug-Coated Balloon Dilation Catheter Asking for Feedback

    Posted 21-Jul-2022 09:17

    NMPA drafted the "Guideline of Drug-coated Balloon Dilation Catheter" on June 22, 2022 for feedback.

    This newly drafted guideline provides general requirements of registration and review process for drug-coated balloon dilation catheters classified as 03-13-06 under Class III medical devices. It covers key requirements for registration units, composition materials, research materials, and clinical evaluation etc.

    For review documents and research materials, below are more details on materials related requirements.  The clinical requirements will follow the appropriate pathway of CER or local clinical trial or a hybrid based on your current overseas clinical evidence.

    Composition materials
    Apart from general requirements of product performance as guided in the "Guideline for Technical Review of Registration of Balloon Dilation Catheters"; this guideline also listed the following research materials to support product performance:

    1. Drug studies: identification and purity of drugs, drug loading, drug degradation products/impurities, in-vitro drug release studies, solvent residues, etc.
    2. Characteristics and safety of the degradable matrix and degradation products (if applicable)
    3. Basis of drug dose choices
    4. Basis of drug-loading matrix (if applicable)
    5. Interactions between medical devices and drugs
    6. Characterization of drug coating distribution (integrity, thickness, uniformity)
    7. Intraoperative compatibility (if applicable)
    8. Safety and effectiveness studies in magnetic navigation (if applicable)
    9. Durability of drug coating
    10. Residual drug dose
    11. Quantitation of number of particulates released, particulates identifications, and crystallinity characterization

    I'd love to hear your experience or challenges in registration of Drug-coated Balloon Dilation Catheters, if you need more details on the clinical or material related requirements, please email me.

     



    ------------------------------
    Grace Fu Palma
    ChinaMed Device, LLC
    MA, U.S.
    gpalma@ChinaMedDevice.com
    978-390-4453
    www.ChinaMedDevice.com
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