China NMPA Medical Device Standardization Administration issued the "Second Batch of Medical Device Classification Results for 2023" on July 13. The document specifies the newly added 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 China manufacturers.
Classification Procedures
China NMPA regulatory process starts from determining the medical device classification (three classes), 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 the classification results, released two or three times each year, as reference. If you cannot figure out the device classification from the catalogue, you will need to file for classification request to NMPA.
The product identified by the Classification Results include but are not limited to the following. It also briefly describes each with the classification code.
Class III
1. Prostate surgery navigation system
2. Electromagnetic stimulation of the neuro-navigation system
3. Mechanical thrombus resection power system
4. Disposable bipolar RF ablation electrodes
5. Single-use intracranial guided dilation catheter
6. In vitro thrombosis negative pressure suction pump set
7. Single-use mechanical thrombus removal system
8. Disposable manual negative pressure thromboaspirator
9. Antifoam and additive for gastrointestinal ultrasound diagnosis
10. Digital color ultrasound diagnostic instrument
11. Accessories for brain tissue oxygen partial pressure and temperature monitoring system
12. Transcranial DC stimulator
Class II
1. Machinery for endoscope fixation and clamping
2. Disposable biopsy gun
3. Disposable peritoneal dialysis catheter fixation forceps
4. Thoracocentesis traction needle
5. Fascial suture for endoscope
6. Disposable adjustable venous compression of the hemostat
7. Single-use balloon augmentation pressure pump
8. Personalized microcatheter shapers
9. Trigeminal nerve dilation balloon catheter kit
10. Single-use trigeminal neuralgia compression balloon device
11. Pedicle puncture apparatus
12. Bone meal collector
13. Oral radiation therapy stents
14. Oral braces for radiotherapy
Combination products
1. Medicated far-infrared sticker
2. Antiviral nasal spray
3. Titanium silver metal isolation cloth
4. Traumatic hemostatic dressings
5. Nitric oxide nasal sprayer
The documents also include product examples that are not managed as medical devices, standalone medical devices, and combination products. If you cannot figure out your device classification from the catalogue or have any questions about the Classification Results, please email me.
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Grace Fu
China Med Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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