The NMPA Medical Device Standardization Administration issued the “Second Batch of Medical Device Classification Results for 2023” on July 13. The document identifies 71 Class III, 80 Class II and 35 Class I medical devices, and 5 combination products. It is the summary of classification requests submitted by overseas and domestic manufacturers.
It also lists the contact numbers for each NMPA review department. If you want a face-to-face consultation, just as FDA’s pre-sub, with NMPA reviewers, please email us at info@ChinaMedDevice.com.
Classification Procedures
The NMPA regulatory process is kicked off by classifying your device. First, you need to go through the China medical device classification catalog, effective since August 1, 2018. You can find the category, subcategory, example of device names, product description and intended use for your device.
If not clear, you can look up on the classification results, released two or three times each year, for reference. When you cannot figure out the device classification in the catalogue and results, you will need to file for classification request.
The List of NMPA Classification Results 2023
The devices identified by the Classification Results include but not be limited to the following. It also briefly describes each device with classification code.
Class III
- Prostate surgery navigation system
- Electromagnetic stimulation of the neuro-navigation system
- Mechanical thrombus resection power system
- Disposable bipolar RF ablation electrodes
- Single-use intracranial guided dilation catheter
- In vitro thrombosis negative pressure suction pump set
- Single-use mechanical thrombus removal system
- Disposable manual negative pressure thromboaspirator
- Antifoam and additive for gastrointestinal ultrasound diagnosis
- Digital color ultrasound diagnostic instrument
- Accessories for brain tissue oxygen partial pressure and temperature monitoring system
- Transcranial DC stimulator
Class II
- Machinery for endoscope fixation and clamping
- Disposable biopsy gun
- Disposable peritoneal dialysis catheter fixation forceps
- Thoracocentesis traction needle
- Fascial suture for endoscope
- Disposable adjustable venous compression of the hemostat
- Single-use balloon augmentation pressure pump
- Personalized microcatheter shapers
- Trigeminal nerve dilation balloon catheter kit
- Single-use trigeminal neuralgia compression balloon device
- Pedicle puncture apparatus
- Bone meal collector
- Oral radiation therapy stents
- Oral braces for radiotherapy
Combination products
- Medicated far-infrared sticker
- Antiviral nasal spray
- Titanium silver metal isolation cloth
- Traumatic hemostatic dressings
- Nitric oxide nasal sprayer
