Requirements for import declaration of medical devices:

 

1. Registration and filing

 

According to the "Regulations on the Supervision and Administration of Medical Devices", a representative office established in China or a designated Chinese company legal person shall submit the application materials for registration and filing to the drug regulatory department of the State Council. Dental medical devices can only be imported if the registration/filing certificate for imported medical devices is obtained.

 

Class I medical devices are subject to product filing management, Class II medical devices are subject to product filing management, and Class III medical devices are subject to product registration management.

 

Chinese manual, Chinese label

 

The "Regulations on the Supervision and Administration of Medical Devices" stipulates that imported medical devices should have Chinese instructions, Chinese labels, instructions, and labels should meet the requirements of this regulation and relevant mandatory standards, and the origin of the medical device and overseas medical devices should be indicated in the instructions. The legal person name, address and contact information of the registrant company in China. There are no Chinese instructions, Chinese labels or instructions. Labels that do not comply with the provisions of this article shall not be imported.

 

(9018990), 90184100, 90184910) belong to the statutory inspection of goods and implement destination inspection. After the application is approved by the customs and leaves the customs supervision area of the port, the company will transport and store it by itself, and it will be inspected by the customs for domestic sales or use. It can be sold or used only after passing the inspection.

 

 

2. Materials for customs declaration procedures for import of medical devices

 

1. Commercial contracts, shipping bills, and business-related documents

 

2. Application for Customs Declaration and Inspection

 

3. Medical device quarantine certificate

 

4. Right to operate import and export

 

5. Certificate of Origin

 

6. The record number of the medical device supplier's registration and cancellation in China