The NMPA Medical Device Standardization Administration issued the “First Batch of Medical Device Classification Results for 2024” on April 4, 2024. The document identifies 57 Class III, 101 Class II and 23 Class I medical devices, and 10 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
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
- Ultrasonic high-frequency surgical integrated system disposable separation blade
- Auxiliary cardiac pump system
- Vascular interventional control system
- Intravenous ablation closure microcatheter
- Spinal surgery implant photo-functional Irradiator
- guide catheter control system
- Ultrasonic assisted heating system
- Thrombus suction negative pressure suction pump
- Occluded balloon catheter
- anchoring guidewire
- Soft tissue localization marker kit
- Disposable ventricular imaging catheter
- anesthesia vaporizer
- Cell sorter
- Implantable neurostimulation lead kit
- … …
Class II
- Fiber optics for surgical lighting
- Medical endoscope/fiber optic auxiliary tools
- Disposable endoscopic knife
- Fiber optic delivery guides and stone aspirators
- Non-absorbable silicone rubber suture
- Disposable sleeve gastric balloon catheter
- Adjustable curved sheath
- 3D printing personalized medical polymer splint
- 3D printing personalized medical external fixation brace
- Color doppler ultrasound system
- Biliary and pancreatic duct microscopy imaging probe catheter
- Electronic endoscope image processing system
- Disposable endoscopic tip cap catheter kit
- Positive pressure ventilation therapy machine
- oxygen inhalation device
- Medical oxygen supply regulator
- Airway foreign body negative pressure suction set
- Warm physiotherapy device
- Light therapy device
- Lower limb elevation and traction devices
- … …
Combination products
- Nasal anti-allergy gel
- hydrogel for ophthalmic surgery
- Medical copper-based dressing
- Ammonium fluoride silver anti-caries agent
- Anti-nasal allergy spray
- Medical oil gauze
- Disposable vaginal packing absorbent suppository
- Fluorinated foam
- Sterile ointment wound dressing
- Articular cartilage repair materials
