China regulatory update | Draft review guideline for cardiac electrophysiology 3D mapping systems opens for public comment

On October 16, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration released the draft “Guideline for Registration Review of Cardiac Electrophysiology 3D Mapping Systems” for public comment. The comment period closes on October 31, 2026.

The draft applies to the main unit of cardiac electrophysiology 3D mapping systems and single-use cardiac electrophysiology mapping catheters. These are Class III medical devices in China, with classification codes 07-03-02 for the main unit and 07-10-02 for the catheter. The document covers key review points including regulatory information, summary materials, non-clinical data, clinical evaluation, and instructions for use/labels. It highlights system-catheter compatibility, localization and modeling performance, ECG signal quality, software and cybersecurity, biological evaluation, cleaning/disinfection/sterilization, usability, and shelf-life studies.

For products using electric-field localization, magnetic localization, or hybrid magnetic-electric localization, the draft requires performance validation of localization accuracy, stability, and reproducibility according to the localization principle. The draft also states that animal studies should generally be conducted for initial registration, focusing on localization stability, radiographic visibility, ECG performance, mapping/modeling, and interference resistance, with emphasis on combined-use validation between the main unit and catheter.

For teams working on electrophysiology mapping, 3D modeling, magnetic/electric localization catheters, ablation integration, and registration strategy in China, this is a draft worth reviewing early. Comments can be sent to guobb@ydcmdei.org.cn or caoyue@cmde.org.cn, using the subject/file name format “Comments on the Draft Guideline for Registration Review of Cardiac Electrophysiology 3D Mapping Systems + organization name.”