The NMPA issued the “Announcement on Adjustments to Certain Items in the Medical Device Classification Catalog” on January 4, 2026. The adjustments are aimed to keep up with the international recognized requirements and further lessen the manufacturers’ regulatory burden.
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Full List
Most of the devices included in this adjustment involve revisions to the device description; three devices have been reclassified to a lower class:
- Delivery Guide Devices (such as Single-use Sterile Delivery Guide): down-classified from Class III to Class II
- certain Inner Ear Prostheses: down-classified from Class III to Class II
- Manual Patient Wheelchair: down-classified from Class II to Class I
For certain medical devices, classification is no longer uniform but depends on specific indications. For example, Inner Ear Prostheses are now divided into Class II and Class III: tympanoplasty prostheses and stapedoplasty prostheses implanted in the ear to reconstruct the ossicular chain or treat otosclerosis with a fixed stapes remain Class III, while tympanic ventilation tubes, middle ear ventilation/drainage tubes, and ventilating tubes used for patients with secretory otitis media, Eustachian tube dysfunction, or tympanic membrane retraction for ventilation, drainage, and drug delivery purposes are classified as Class II.
Below is the full list of devices mentioned in the adjustments:
- Closure Clip
- Delivery Guide Device
- Nasal Oxygen Cannula
- Ultrasound Therapy Equipment Accessories
- Single-/Multi-component Absorbable Bone Fixation Devices
- Sports Injury Soft Tissue Repair and Reconstruction Implants
- Inner Ear Prostheses
- Collagen Scaffold Materials
- Chitosan-containing Intra-articular Fluid
- Collagen Patch Dressing
- Nasal Care Devices
- Tooth Whitening Equipment and Supporting Bleaching Agents
- Grinding and Polishing Materials
- Dental Separating Agents
- Desensitizing Agents
- Caries Prevention Materials
- Tooth Whitening Materials
- Vaginal Irrigation / Drug Delivery Devices
- Medical Gynecological Pads
- Gynecological Physical Therapy Devices
- Gynecological Prosthetic Devices
- Assisted Reproduction Micro Instruments
- In Vitro Assisted Reproduction Fluids
- Specialized Instruments for Assisted Reproduction
- Medical Wheelchair
- Acupoint Pressure Stimulation Devices
- Nucleic Acid Amplification Analyzers
- Biochip Analyzers
Registration Requirements
For devices already accepted for registration but not yet approved, review will continue under the original classification. If approved, the registration certificate will be issued with the adjusted product class noted in the remarks section.
For registered devices reclassified from Class III to Class II, existing certificates remain valid until expiry. Renewal applications must be submitted under the new classification at least six months before expiration, and renewed certificates will reflect the updated class.
For registered devices reclassified from Class II to Class I, existing certificates remain valid during their term, and product filing must be completed before expiration.