The NMPA Medical Device Standardization Administration released the “Medical Device Classification Results for 2020-2021”. The document identifies 155 Class III, 505 Class II and 143 Class I medical devices, and 20 combination products.
The Medical Device Classification List
The devices identified by the Medical Device Classifications Results include but not be limited to the following:
Class III
- Disposable endoscope suture system+C2:C31
- Arterial thrombectomy balloon catheter
- Vertebroplasty kits
- acellular dermal matrix
- heart valve biopatch
- Prostate urethral stent system
- Absorbable lifting thread for plastic surgery
- Modified sodium hyaluronate gel for injection
- Pump-type central venous catheter irrigator
- Percutaneous gastrostomy kit
- X-ray bone age detection equipment
- deep brain electrodes
- Disposable percutaneous renal dilators and accessories
- Disposable endoscopic cutting stapler and components
- Disposable titanium-nickel memory alloy internal anal fistula stapler
Class II
- Disposable nasal stent
- Disposable endoscopic compression balloon
- Accessory kits for endoscopic surgical instrument control systems
- visual nasoenteric tube
- non-absorbable surgical sutures
- Biliary dilation catheter
- Skull drill
- Disposable sterile digestive traction clip
- Disposable small intestine isolation protection device
- Disposable trigeminal neuralgia compression balloon device
- Flushable cutting
- Disposable sterile craniotomy fixator
Class I
- Nasal introducer
- Surgical power handle connection cannula
- Dialysis care package
- Neck stoma leak proof silicone
- External drainage tube
- External drainage tube
- Oral abutment substitute
- Negative pressure drainage
- Ophthalmic surgery drainage
- Suspension training system
Combination products
- Intragastric weight loss balloon system
- Sodium hyaluronate composite microspheres for injection
- Chlorhexidine oral desensitization antibacterial solution
- Protein scaffolding materials
- wound healing gel dressing
If you have any questions about Medical Device Classifications, please contact us at info@chinameddevice.com.
