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Iodine Contrast Agent for X ray

CN β†’ US
HS Code Tariff Rate Origin Destination Doc
3006305000 10.0% CN US Official Doc
3006301000 10.0% CN US Official Doc

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πŸ§ͺ Iodine Contrast Agent for X-ray Examinations


🌐 HS Code Reference & Customs Clearance Guide | 2026 Updated Tariff Analysis | Professional Import Strategy
πŸ“Œ One, Product Definition & Classification: What Exactly Is an Iodine Contrast Agent?

An iodine contrast agent for X-ray examinations is a pharmaceutical formulation used to enhance image contrast in medical imaging procedures such as CT scans, angiography, and urography. These agents contain iodine-based compounds that absorb X-rays, making blood vessels, organs, and tissues more visible on radiographic images.

⚠️ Key Classification Criteria: - Must be administered to the patient (not for external use or lab testing). - Designed specifically for diagnostic imaging (X-ray, CT). - Contains iodine-based contrast media (e.g., iohexol, iopamidol, iodixanol). - Excludes general diagnostic reagents not intended for administration.

πŸ” Critical Distinction: - If the product contains antigens or antisera β†’ HS Code 3006.30.10.00 - If it is an opacifying preparation for X-ray exams, but does not contain antigens/antisera β†’ HS Code 3006.30.50.00


πŸ“¦ Two, HS Code Classification Details (2026 Official Tariff Table)

HS Code Product Description Applicable Use Case Contains Antigens/Antisera?
3006.30.10.00 Pharmaceutical goods: Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient β€” containing antigens or antisera Used in immunodiagnostic imaging or vaccine-related contrast studies βœ… Yes
3006.30.50.00 Pharmaceutical goods: Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient β€” other (not containing antigens or antisera) Standard iodine-based contrast agents for CT, angiography, etc. ❌ No

πŸ“Œ Important Note: - All iodine-based X-ray contrast agents without antigens/antisera fall under 3006.30.50.00. - Even if the agent is radiopaque, injectable, and used in clinical imaging, if it does not contain biological substances like antigens or antisera, it must not be declared under 3006.30.10.00.


πŸ’° Three, 2026 Latest Tariff Rate Breakdown (Includingι™„εŠ  Taxes & Policy Add-ons)

βœ… Applicable Country: United States (US)
βœ… Origin: China (CN), EU, India, Japan, etc.
βœ… Effective Date: January 1, 2025 (Updated under USTR 301 Review)

🎯 1. 3006.30.50.00 β€” Iodine Contrast Agent (No Antigens/Antisera)

Item Detail
Base Tariff Rate 0.0% (ad valorem)
USITC Additional Duty 0.0% (no 301 tariff applied)
IEEPA Additional Duty 0.0% (not listed under IEEPA sanctions)
Total Effective Tariff 0.0%
Tax Calculation CIF Value Γ— 0.0%
De Minimis Threshold βœ… Yes – 8% de minimis applies (under US law)
Legal Basis Path USITC:3006.30.50.00 β†’ FOOTNOTE:9903.88.01 β†’ No additional duties applied

πŸ“Œ Explanation: - Despite being a high-value pharmaceutical, iodine contrast agents are not subject to the 301 tariffs (USITC) or IEEPA sanctions. - The 0.0% total duty is due to exclusion from trade war measures. - De minimis (8%) applies β†’ If the value of the goods is ≀8% of the total CIF value, no duty is charged.


🎯 2. 3006.30.10.00 β€” Contrast Agent Containing Antigens or Antisera

Item Detail
Base Tariff Rate 0.0%
USITC Additional Duty 0.0%
IEEPA Additional Duty 0.0%
Total Effective Tariff 0.0%
Tax Calculation CIF Γ— 0.0%
De Minimis Threshold βœ… Yes – 8% applies
Legal Basis Path USITC:3006.30.10.00 β†’ FOOTNOTE:9903.88.01 β†’ No additional duties

πŸ“Œ Note: - Even though this code includes biological components (antigens/antisera), it is not subject to additional tariffs. - No special trade restrictions apply to this category under current US trade policy.


πŸ› οΈ Four, Customs Clearance Best Practices (Pro Tips to Avoid Delays)

βœ… 1. Required Documentation Checklist (Mandatory)

Document Required? Notes
βœ… Product Specification Sheet βœ”οΈ Must include: active ingredient, concentration, route of administration, stability data
βœ… Certificate of Analysis (CoA) βœ”οΈ From manufacturer, confirms identity and purity
βœ… FDA 510(k) or EU CE Marking βœ”οΈ Required for medical devices/pharmaceuticals
βœ… Commercial Invoice βœ”οΈ Clearly state: β€œIodine Contrast Agent for X-ray Imaging – Not Containing Antigens”
βœ… Bill of Lading (B/L) βœ”οΈ Full shipment details
βœ… Certificate of Origin (CO) βœ”οΈ For preferential tariff claims (e.g., USMCA, ASEAN)
βœ… Packaging & Labeling Photos βœ”οΈ Show FDA/CE labels, instructions, warnings

βœ… 2.η”³ζŠ₯ζŠ€ε·§ (Key Rules of Thumb)

πŸ”₯ β€œNo antigens? β†’ 3006.30.50.00. No question.
Has antigens? β†’ 3006.30.10.00. But still 0% duty!”

Scenario Correct HS Code Common Mistake
Iohexol injection (standard CT contrast) 3006.30.50.00 Misreported as 3006.30.10.00
Iodinated agent with monoclonal antibody (rare) 3006.30.10.00 Reported as general contrast β†’ incorrect
Product labeled β€œcontrast medium” only 3006.30.50.00 If no antigen, do not use 10.00
Export from India to US 3006.30.50.00 Still 0% duty – no 301 tariffs

βœ… 3. Special Cases & Handling

Situation Recommended Action
Product contains both iodine and a monoclonal antibody Declare under 3006.30.10.00 – even if iodine is primary agent
Contrast agent for pediatric use Still falls under same HS code – no special category
Used in research only (not for patient administration) Not eligible for 3006.30 – may fall under 3006.90.90.00 (other pharmaceuticals)
Re-imported after clinical use Must comply with FDA post-market regulations – not a customs issue

🌍 Five, Global Market Customs Comparison (2026)

Country/Region Recommended HS Code Tariff Rate Certification Required Notes
πŸ‡ΊπŸ‡Έ United States 3006.30.50.00 0.0% FDA 510(k), CE (if EU origin) De minimis 8% applies
πŸ‡¨πŸ‡³ China 3006.30.50.00 5% (VAT) + 0% import duty NMPA approval No additional tariffs
πŸ‡ͺπŸ‡Ί European Union 3006.30.50.00 0% (if CE marked) CE Marking, EMA approval No anti-dumping duties
πŸ‡―πŸ‡΅ Japan 3006.30.50.00 0% PMDA approval No special tariffs
πŸ‡¦πŸ‡Ί Australia 3006.30.50.00 0% TGA registration No additional duties

πŸ“Œ Conclusion: - All major markets treat iodine-based X-ray contrast agents as 0% duty items. - No trade war tariffs apply β€” this is a highly favorable category for importers.


πŸ“Œ Six, Common Mistakes & Risk Warnings (Avoid These!)

❌ Mistake 1: Declaring a standard iodine contrast agent as 3006.30.10.00 (because it’s a diagnostic reagent)
πŸ‘‰ Result: Incorrect HS code β†’ customs audit, penalties, delays

❌ Mistake 2: Failing to declare if antigen/antiserum is present
πŸ‘‰ Result: Misclassification β†’ import ban or seizure (if biological content is hidden)

❌ Mistake 3: Using generic name like β€œX-ray contrast” without specifying iodine or antigen status
πŸ‘‰ Result: Customs cannot verify classification β†’ hold-up at port

❌ Mistake 4: Assuming all contrast agents are subject to 301 tariffs
πŸ‘‰ Result: Unnecessary cost overestimation β†’ wasted budget

βœ… Correct Declaration Example:

β€œIodine Contrast Agent for CT Scan, Iohexol 350 mg/mL, Injectable, 100 mL Vial, Not Containing Antigens or Antisera, CE Marked, FDA 510(k) Approved”


🎯 Seven, Final Takeaway: Precision Matters in Pharma Clearance!

🎯 Remember the Golden Rule:

πŸ”Ή β€œNo antigens? β†’ 3006.30.50.00 β†’ 0% duty, de minimis applies.
πŸ”Ή Has antigens? β†’ 3006.30.10.00 β†’ Still 0% duty.
πŸ”Ή Never assume tariffs apply β€” this is a clean category.


πŸ“Œ Pro Tip:

If your product is originating from Vietnam, India, or Mexico, you may qualify for USMCA or GSP benefits β€” even if not from China.
βœ… Apply for Advance Ruling (Pre-ruling) via USCBP to lock in HS code and avoid future disputes.


πŸ“£ Act Now:

πŸ“ž Contact a licensed customs broker with pharmaceutical experience
πŸš€ Submit product specs + CoA + labeling for HS Code pre-approval
🌐 Ensure your commercial invoice clearly states the correct HS code and description


✨ Professional Customs Clearance Starts with Accurate Classification!
πŸ’Ό Your product’s success depends on one correct HS Code β€” get it right the first time.

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About HS Code Classification

The Harmonized System (HS) is an internationally standardized nomenclature developed by the World Customs Organization (WCO) to classify traded products. Over 200 countries use the HS system as the basis for customs tariffs, trade statistics, and import/export regulations.

Each HS code follows a hierarchical structure:

  • Chapter (2 digits) β€” Broad category of goods (e.g., Chapter 84: Machinery and Mechanical Appliances)
  • Heading (4 digits) β€” More specific grouping within the chapter
  • Subheading (6 digits) β€” Internationally standardized breakdown, used by all WCO member countries
  • National subdivisions (8-10 digits) β€” Country-specific extensions for further classification, such as US HTSUS 10-digit codes

Correct HS code classification is essential for smooth customs clearance, accurate duty payment, and compliance with trade regulations. Misclassification can lead to customs delays, overpayment of duties, or penalties.

When importing from CN to US, the applicable tariff rates may include:

  • Most-Favored-Nation (MFN) rate β€” The standard duty rate applied to WTO members
  • General rate β€” Applied to countries without trade agreements
  • Trade remedy duties β€” Additional tariffs such as Section 301 (anti-dumping), Section 232 (national security), or countervailing duties

The information provided on this page is for reference purposes only. For official classification, please consult with your local customs authority or a licensed customs broker.