Four Innovative Products Including Implantable Deep Brain Stimulation Electrode Lead Kit Approved By China NMPA


On May 28, 2024, China NMPA approved the registration applications for four innovative products: the Implantable Deep Brain Stimulation (DBS) Electrode Lead Kit, the Dual-Channel Rechargeable Implantable DBS Pulse Generator Kit, the Dual-Channel Implantable DBS Pulse Generator Kit, and the Implantable DBS Extension Lead Kit.

These products represent the first domestically produced directional DBS devices. When used together, they can stimulate the subthalamic nucleus or the internal segment of the globus pallidus, providing combined treatment for patients with advanced levodopa-responsive Parkinson’s disease whose symptoms cannot be effectively controlled by medication alone. Compared to traditional electrodes, these new products offer directional stimulation to specific functional subregions of the target nuclei. This capability reduces the risk of side effects from DBS even if the electrode is slightly misaligned, thereby decreasing the need for additional surgeries to reimplant electrodes.

The regulatory authorities will enhance post-market supervision of these products to ensure the safety of patients using these medical devices. BradyKnows Medical, an elite team specializing in facilitating access to the Chinese market. Our comprehensive knowledge and meticulous approach ensure seamless compliance with evolving regulations, making them an invaluable partner in navigating the complexities of medical device classification and registration. For further inquiries regarding medical device registration, please contact: