Special Goods Import and Export: A Complete Process and Precautions Guide

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Industry Encyclopedia

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Time of issue：

2025-04-25 16:45

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In international trade, the import and export of special items has always been a field of significant attention and complexity. Understanding the processes and precautions involved in the import and export of special items is crucial, whether you are a biopharmaceutical company or a professional engaged in related trade. Today, let's thoroughly examine the entire process of importing and exporting special items, along with key points to pay special attention to.

I. What are special items?

Special items generally refer to items such as microorganisms, human tissues, biological products, blood and blood products. Due to their unique nature and potential risks, these items require strict approval and regulatory processes for import and export.

II. Detailed Import and Export Process

(A) Application for Approval

The first step in importing or exporting special items is to apply for approval from customs. For incoming special items, an application should be submitted to the subordinate customs at the destination; for outgoing special items, the application should be submitted to the subordinate customs of the location. Applications can be submitted through the "Internet + Customs" platform or the "Customs Entry and Exit Special Items Sanitary Quarantine Supervision System".

The following materials need to be submitted when applying:

• Application Form for Sanitary Quarantine Approval of Entry/Exit Special Items

• Descriptive materials for special items (e.g., components, uses, production processes, etc.)

• Relevant certificates and proofs (e.g., production licenses, quality inspection reports, etc.)

Customs will complete the approval within 20 working days of receiving the application. This may be extended by 10 working days under special circumstances.

(B) Declaration

After approval is granted, the cargo owner or agent must declare to customs after the special items arrive at the port (entry) or before departure (exit). The declaration requires the submission of the "Special Items Approval Form" and other relevant materials.

(C) Customs Inspection

Customs will inspect the name, components, batch number, specifications, and quantity of special items to ensure consistency with the approved content. For imported special items that require laboratory testing, the cargo owner or agent must store them in a qualified place as required by customs before transportation or use can be permitted.

(D) Subsequent Supervision

For imported special items requiring subsequent supervision, the using unit must report to the customs at the destination within 30 days of entry, at which point customs will implement subsequent supervision.

III. Matters to Note

(A) Qualification Requirements

Applicants must possess biosafety control capabilities commensurate with the special items being imported or exported. If the special items may contain pathogenic microorganisms, the applicant cannot be a natural person.

(B) Material Preparation

Submitted materials must be complete and conform to the legally prescribed format. Units applying for special item approval for the first time must also provide electronic copies of materials such as basic unit information and laboratory biosafety qualification certificates.

Customs will implement tiered management of special items based on risk level. The approval and supervision of high-risk special items are stricter, so companies need to prepare for and assess risks in advance.

(D) Compliant Operations

Cargo owners or agents must strictly abide by laws, regulations, and relevant standards, and legally and safely import, export, produce, operate, and use special items.

(E) Personal Carry-on

If an individual carries blood products or biological products for personal use and solely for disease prevention or treatment, sanitary quarantine approval is not required. However, proof from a hospital must be shown to customs, and the quantity is limited to one course of treatment.

(F) Adjustment of Supervisory Scope

According to the latest regulations, goods under the management of pharmaceuticals, veterinary drugs, and medical devices, and imported/exported environmentally friendly microbial agents are no longer subject to entry/exit special item sanitary quarantine approval. However, these items still need to meet other customs supervision requirements.

The process of importing and exporting special items is complex, but by following the prescribed steps and paying attention to the relevant details, successful completion is possible. We hope the above information is helpful. If you have any further questions, please feel free to leave a message!

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The above content is for reference only. Please refer to the latest regulations of the General Administration of Customs and relevant regulatory authorities for specific operations.

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