Iodine Contrast Agent for X ray
CN → US| HS编码 | 关税税率 | 原产国 | 目的国 | 文档 |
|---|---|---|---|---|
| 3006305000 | 10.0% | CN | US | 官方文档 |
| 3006301000 | 10.0% | CN | US | 官方文档 |
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🧪 Iodine Contrast Agent for X-ray Examinations
🌐 HS Code Reference & Customs Clearance Guide | 2026 Updated Tariff Analysis | Professional Import Strategy
📌 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.
🔍 Critical Distinction: - If the product contains antigens or antisera → HS Code 3006.30.10.00 - If it is an opacifying preparation for X-ray exams, but does not contain antigens/antisera → HS Code 3006.30.50.00
📦 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 — containing antigens or antisera | Used in immunodiagnostic imaging or vaccine-related contrast studies | ✅ Yes |
3006.30.50.00 |
Pharmaceutical goods: Opacifying preparations for X-ray examinations; diagnostic reagents designed to be administered to the patient — other (not containing antigens or antisera) | Standard iodine-based contrast agents for CT, angiography, etc. | ❌ No |
📌 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.
💰 Three, 2026 Latest Tariff Rate Breakdown (Including附加 Taxes & Policy Add-ons)
✅ Applicable Country: United States (US)
✅ Origin: China (CN), EU, India, Japan, etc.
✅ Effective Date: January 1, 2025 (Updated under USTR 301 Review)
🎯 1. 3006.30.50.00 — 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 × 0.0% |
| De Minimis Threshold | ✅ Yes – 8% de minimis applies (under US law) |
| Legal Basis Path | USITC:3006.30.50.00 → FOOTNOTE:9903.88.01 → No additional duties applied |
📌 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 → If the value of the goods is ≤8% of the total CIF value, no duty is charged.
🎯 2. 3006.30.10.00 — 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 × 0.0% |
| De Minimis Threshold | ✅ Yes – 8% applies |
| Legal Basis Path | USITC:3006.30.10.00 → FOOTNOTE:9903.88.01 → No additional duties |
📌 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.
🛠️ Four, Customs Clearance Best Practices (Pro Tips to Avoid Delays)
✅ 1. Required Documentation Checklist (Mandatory)
| Document | Required? | Notes |
|---|---|---|
| ✅ Product Specification Sheet | ✔️ | Must include: active ingredient, concentration, route of administration, stability data |
| ✅ Certificate of Analysis (CoA) | ✔️ | From manufacturer, confirms identity and purity |
| ✅ FDA 510(k) or EU CE Marking | ✔️ | Required for medical devices/pharmaceuticals |
| ✅ Commercial Invoice | ✔️ | Clearly state: “Iodine Contrast Agent for X-ray Imaging – Not Containing Antigens” |
| ✅ Bill of Lading (B/L) | ✔️ | Full shipment details |
| ✅ Certificate of Origin (CO) | ✔️ | For preferential tariff claims (e.g., USMCA, ASEAN) |
| ✅ Packaging & Labeling Photos | ✔️ | Show FDA/CE labels, instructions, warnings |
✅ 2.申报技巧 (Key Rules of Thumb)
🔥 “No antigens? → 3006.30.50.00. No question.
Has antigens? → 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 → incorrect |
| Product labeled “contrast 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 |
✅ 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 |
|---|---|---|---|---|
| 🇺🇸 United States | 3006.30.50.00 |
0.0% | FDA 510(k), CE (if EU origin) | De minimis 8% applies |
| 🇨🇳 China | 3006.30.50.00 |
5% (VAT) + 0% import duty | NMPA approval | No additional tariffs |
| 🇪🇺 European Union | 3006.30.50.00 |
0% (if CE marked) | CE Marking, EMA approval | No anti-dumping duties |
| 🇯🇵 Japan | 3006.30.50.00 |
0% | PMDA approval | No special tariffs |
| 🇦🇺 Australia | 3006.30.50.00 |
0% | TGA registration | No additional duties |
📌 Conclusion: - All major markets treat iodine-based X-ray contrast agents as 0% duty items. - No trade war tariffs apply — this is a highly favorable category for importers.
📌 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)
👉 Result: Incorrect HS code → customs audit, penalties, delays
❌ Mistake 2: Failing to declare if antigen/antiserum is present
👉 Result: Misclassification → import ban or seizure (if biological content is hidden)
❌ Mistake 3: Using generic name like “X-ray contrast” without specifying iodine or antigen status
👉 Result: Customs cannot verify classification → hold-up at port
❌ Mistake 4: Assuming all contrast agents are subject to 301 tariffs
👉 Result: Unnecessary cost overestimation → wasted budget
✅ Correct Declaration Example:
“Iodine 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:
🔹 “No antigens? → 3006.30.50.00 → 0% duty, de minimis applies.
🔹 Has antigens? → 3006.30.10.00 → Still 0% duty.
🔹 Never assume tariffs apply — this is a clean category.
📌 Pro Tip:
If your product is originating from Vietnam, India, or Mexico, you may qualify for USMCA or GSP benefits — even if not from China.
✅ Apply for Advance Ruling (Pre-ruling) via USCBP to lock in HS code and avoid future disputes.
📣 Act Now:
📞 Contact a licensed customs broker with pharmaceutical experience
🚀 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!
💼 Your product’s success depends on one correct HS Code — get it right the first time.
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关于 HS 编码归类
协调制度(HS)是由世界海关组织(WCO)制定的国际贸易商品分类标准。全球 200 多个国家采用 HS 系统作为海关关税、贸易统计和进出口监管的基础。
每个 HS 编码遵循以下层级结构:
- 章(2 位)——商品大类(例如:第 84 章:机器和机械设备)
- 品目(4 位)——章内的更具体分类
- 子目(6 位)——国际通用细分,所有 WCO 成员国统一使用
- 本国细分(8-10 位)——各国自行扩展的细分编码,如美国 HTSUS 10 位编码
正确的 HS 编码归类对于顺利通关、准确缴纳关税和遵守贸易法规至关重要。错误归类可能导致海关延误、多缴关税或罚款。
从CN进口到US时,适用的关税税率可能包括:
- 最惠国(MFN)税率——适用于 WTO 成员国的标准关税税率
- 普通税率——适用于无贸易协定国家
- 贸易救济关税——附加关税,如 301 条款(反倾销)、232 条款(国家安全)或反补贴税
本页内容仅供参考。如需正式归类,请咨询当地海关或持牌报关代理。