On May 13, 2025, the National Medical Products Administration (NMPA) released its updated “Catalogue of Medical Devices Exempt from Clinical Evaluation (2025),” as outlined in Announcement No. 19 of 2025. This move aims to further optimize medical device registration and regulatory management in China.
The newly updated catalogue now includes 1,047 device types, with 27 new products added in this edition. The new additions range from personalized 3D-printed surgical models and advanced remote monitoring systems to various disposable sterile needles and analyzers, reflecting the rapid evolution and diversification of medical technologies.
Highlights of the 27 newly exempted device types:
- Personalized 3D-Printed Surgical Model
- Delivery-Type Intracranial Balloon Dilation Catheter
- Atrial Septal Puncture Sheath
- Otoscopic Endoscope
- Spinal Endoscope
- Non-Invasive Dynamic Blood Pressure Recorder
- Electromyography Evoked Potential Instrument
- Telemetry Monitoring System
- Remote Monitoring System
- High-Flow Respiratory Humidification Therapy Device
- Indwelling Needle for Dialysis
- Disposable Sterile Injection Needle
- Disposable Sterile Side-Hole Blunt Needle
- Disposable Endoscopic Injection Needle
- Liposuction Needle
- Eustachian Tube Balloon Catheter
- Intraoral Digital Impression Instrument
- Temporary Crowns and Bridges
- Preformed Polymer-Based Crown and Bridge Materials
- Disposable Acupuncture Needle
- Hematocytology Analyzer
- Integrated Immunoassay Analyzer
- Indirect Immunofluorescence Analyzer
- Biochemical Immunoassay Analyzer
- Urinalysis System
- Other Body Fluid Analyzers
- Other Body Fluid Morphology Analyzers
This regulatory update aims to streamline the device registration process, reduce the clinical evaluation burden for manufacturers, and accelerate market access for qualifying devices within China. Companies whose products are now listed in the exempt catalogue are encouraged to review their registration and clinical strategies promptly. Taking advantage of these exemptions can significantly decrease both the time and cost required for product registration in the Chinese market.