Customer Cases of Medical Device Import Customs Clearance

This case involves a customer who needs to import a batch of electric dental chairs from Germany and transport them to the Shanghai port. They choose SPEED to provide import related services.

Imported medical equipment: dental chair

Product category: Class I medical devices

Classification code: 17-03-02

Product Description: Usually composed of a base support system, foot switch, chair surface, and head rest. A physician chair usually consists of a base support system and a chair surface, which may have a lifting and positioning function, and is usually used in conjunction with a dental chair. Passive products.

Intended use: Used for carrying patients (dental chairs) and medical staff (physician chairs) during dental clinical diagnosis and treatment.

Filing Process

Filing Authority

Filing of imported Class I medical devices: National Drug Administration Department

Filing of imported Class I medical devices: 

1. Prepare foreign language materials and Chinese materials; 

2. Notarization of foreign language materials+signature and seal of Chinese materials; 

3. Online application; 

4. Submit the application at the window; 

5. Accept and review on the spot; 

6. Obtain the filing certificate and complete the filing; 

7. Publicity on the official website.

Filing Time Limit：

Filing of imported Class I medical devices: approximately 1 week to 1 month;