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Things You Shall Know Before You Export/Import Special Goods from/to China

Special goods/articles include microorganism, human tissues, biological products, blood and blood products. Therein, biological products refers  vaccines,  antitoxin, reagents for diagnosis, cytokines, enzyme, enzymic preparations, toxin, antigen, allergen, antibody, antigen-antibody complex, nucleic acid, immunomodulator, microecologics that used at areas related to human medicine and bioscience. 

What documents are required for customs clearance in China for imported special goods/articles?

Sales contract, invoice, packing list, relevant approval documents for example, registration certificate for medical devices and Certificate of Health Quarantine Approval for Special Goods(hereinafter referred to as Certificate of Approval ) business license, Chinese label, product description in Chinese  are required.

Before import/export of special goods, Certificate of Approval shall be obtained. After approval, import/export declarations shall be made to port Customs. 

How to Obtain Certificate of Approval for Imported Special Goods?

Step 1, Submit Application
Before shipping, owner of special goods to imported or its agent shall apply certificate of approval at the regional customs of destination city. 

Step 2, customs acceptance
When the items of application are special goods, the application materials are complete and in legal formats, customs will accept the application.
When the items of application do not need to obtain certificate of approval, customs will reject the application and inform the applicant. 

Step 3, customs review
Customs shall do written review on the application materials in time. As the circumstances may require, customs may hire experts, do on-field assessment, or laboratory testing to verify the essential contents of the application materials. 
When the items of application are special goods, the application materials are complete and in legal formats, customs will accept the application.

Step 4, decision making
When the application meets legal conditions and standards, Customs shall issue the Certificate of Approval. When the application does not meet legal conditions or standards, Customs shall issue written decision that refuse approval. 

Export/Import Declaration to Port Customs After Approval.

Step 1, Declaration
After imported special goods arrive at port, the consignee or its agent shall declare to port of entry with Certificate of Approval for Special goods and other declaration documents.
When declaration documents are not complete or do not meet legal format, Customs shall not allow its entry or exit. 

Step 2, Customs Inspection
Customs shall conduct on-field inspection on special goods to be imported or exported.

Step 3, Follow up Supervision
The user unit of imported special goods that shall accept follow-up supervision(please refer to the remark on the Certificate of Approval ) shall declare to destination customs within 30 days from entry date of special goods and accept follow-up supervision of destination customs.

The required documents for applying Certificate of Approval for Special Goods
1.Application form

2.Description that describes Chinese and English names, category, ingredients, sources, usage, main selling channels, country or region of export/import, manufacturer info,etc.

3.Registration Certificate for Imported Medicine issued by National Medial Products Administration is required for biological products and human blood products that are imported to prevent, diagnose or treat human diseases. 

4.Scientific name of pathogenic microorganism in Chinese and Latin language, description of biological characteristics in English and Chinese, document that proves the producer or user possess relevant bio-safety prevention and control levels shall be provided when imported/exported special goods contains or might contain pathogenic microorganism.

5.Sales Certificate issued by pathogenic microorganism shall be provided for  biological products and human blood products that are exported to prevent, diagnose or treat human diseases.

6.Special goods to be exported that gets involved in management category of human genetic resources shall obtain certificate of approval from Human Genetic Resources Department. Customs shall do system automatic comparison and verification on the electronic data of the relevant approval document.

7.Units that use imported/exported special goods that contains or might contain pathogenic microorganism shall provide bio-safety laboratory qualification certificate that matches the special goods¡¯ bio-safety risk level. Laboratories that above BSL-3 shall obtain approval from organizations that recognized by the country. 

8.To import or export pathogenic microbial flora or poison of high pathogenicity, approval document issued by provincial level (or above) Health Authorities of People¡¯s Government shall be provided.

In the case that the applicant is a unit(company, organization, or enterprise), it shall provide above mentioned documents as well as below materials when apply for Certificate of Approval for Special goods for the first time. 

1.Info of the unit, for example management system certification,address, production place, laboratory facilities, warehouse facilities and equipment, process details of products, production process or flow, etc.,

2.Laboratory Bio-Safety Qualification Certificate 

In the case that the applicant is a natural person, photocopy of the applicant¡¯s identity card shall be provided.

The applicant of imported/exported special goods that contains or might contain pathogenic microorganism shall be natural person.




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