NMPA Releases 59 New Medical Device Registration Guidance Documents for Public Consultation
On September 1, 2026, the Center for Medical Device Evaluation of the National Medical Products Administration published for public consultation 59 draft registration review guidance documents for Class II active medical devices.
This marks a significant step in NMPA's ongoing efforts to streamline and clarify the regulatory pathway for medical device registration in China. The draft guidance documents cover a wide spectrum of product categories, providing manufacturers with clearer technical requirements and review criteria.
Key Product Categories Covered:
Monitoring & Diagnostic Equipment
l Carbon Dioxide Monitors
l Pulse Oximetry Sensors
l Electronic Spirometers
l Exhaled Nitric Oxide Analyzers
l Electroglottographs
l Acoustic Impedance Meters
l Thyroid Function Analyzers
l Infrared Thermography Systems
l Eye Movement Mapping Devices
Therapy & Treatment Devices
l Vacuum Negative Pressure Units
l Peritoneal Dialysis Fluid Warmers
l Warm Needle Therapy Devices
l Moxibustion Devices
l Visual Rehabilitation Equipment
l Cognitive Rehabilitation Equipment
l Tinnitus Rehabilitation Devices
Surgical & Examination Aids
l Gynecological Surgery/Examination Tables
l Motorized Examination Tables
l Endoscope Irrigation/Aspiration Systems
l Endoscope Insufflation Pumps
l Indirect Ophthalmoscopes
l Dental Examination Lights
l Dental Pocket Depth Probes
Sterilization Equipment
l Ethylene Oxide Sterilizers
l Boiling Sterilizers
l Ozone Sterilizers
Laboratory & In Vitro Diagnostic Instruments
l Flow Cytometers
l Electrolyte Analyzers (Manometric Method)
l Microbial Culture Monitors
l Bacterial Endotoxin Detectors
l Helicobacter pylori Analyzers
l Thromboelastographs
l Urinalysis Systems
l Osmometers
l Image Scanners
l Cell Morphology Analyzers
l Biochemical Immunoassay Analyzers
l Microbial Identification and Susceptibility Analyzers
l Image Analysis Instruments
l Gamma Radioimmunoassay Counters
l Fecal Analyzers
l Semen Quality Analyzers
l Reproductive Tract Secretion Analyzers
l Biochip Analyzers
Rehabilitation & Assistive Devices
l Balance Training/Testing Equipment
l Vibration Training Devices
Injection & Infusion Aids
l Syringe Assisted Injectors
Body Composition Analysis
l Body Composition Analyzers
The full list includes 59 guidance documents in total, reflecting NMPA's commitment to regulatory science and the safety and effectiveness of medical devices in the Chinese market.
Submission Deadline
Stakeholders are invited to submit their comments and suggestions by October 8, 2026 via the designated feedback form. The completed form should be sent to the corresponding contact person listed in the official annex.
Shenzhen Hlongmed Biotech Co.,Ltd. Tel：0086-755-86664989 Mob：13560790058 E-mail：consultant@hlongmed.com Add：16th floor, Tianming Technology Building, No.8 Wushitou Road. North High-tech District,Nanshan, Shenzhen, PRC | 
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