Silicone Breast Implant
CN → US| HS编码 | 关税税率 | 原产国 | 目的国 | 文档 |
|---|---|---|---|---|
| 9021310000 | 10.0% | CN | US | 官方文档 |
| 9021390000 | 10.0% | CN | US | 官方文档 |
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AI分析
🩺 Silicone Breast Implants: HS Code Classification & Duty Analysis (2026 Latest)
🌐 HS Code Reference & Customs Clearance Guide | 2026 Official Tariff Schedule | Professional Compliance Strategy
📌 I. Product Definition & Classification: What Exactly Are "Silicone Breast Implants"?
Silicone breast implants are medical devices classified under Chapter 90 of the Harmonized System (HS), specifically under Orthopedic Appliances and Artificial Parts of the Body. They are NOT considered general medical supplies or textiles.
Key Distinction in Classification:
Artificial Joints (9021.31): Implants that replace or supplement joint structures (e.g., knee, hip).
Other Artificial Parts (9021.39): Implants that do NOT function as joints, including breast implants, cranial plates, and hernia meshes.
⚠️ Critical Clarification:
- Silicone breast implants do not replace joints. Therefore, they cannot be classified under9021.31.00.00(Artificial Joints).
- They fall under "Other" artificial parts, specifically9021.39.00.00.
- Misclassification as "artificial joints" can lead to customs delays, audits, or penalties, even if the duty rate happens to be similar in this specific case.
📦 II. HS Code Classification Details (2026 Official Schedule)
Based on the provided , the correct classification for Silicone Breast Implants is as follows:
| HS Code | Product Description | Applicability | Joint Replacement? |
|---|---|---|---|
9021.31.00.00 |
Artificial joints and parts/accessories thereof | Knee, hip, shoulder, elbow implants | ✅ Yes |
9021.39.00.00 |
Other artificial parts of the body and parts/accessories thereof | Silicone breast implants, cranial implants, hernia meshes | ❌ No |
🔍 Key Takeaway:
- Silicone Breast Implants must be classified under9021.39.00.00.
- This code covers "Other artificial parts of the body" that are not joints.
- Accessories (e.g., filling kits, surgical tools specifically designed for implantation) may also fall under this heading if they are exclusively used with these implants, but the primary product is the implant itself.
💰 III. 2026 Tariff Rate Details (Detailed Tax Breakdown)
✅ Applicable Country: United States (US)
✅ Origin: China (CN)
✅ Effective Date: 2025 November 10 onwards (including subsequent imports)
🎯 1. 9021.39.00.00 —— Other Artificial Parts of the Body (Including Breast Implants)
| Item | Details |
|---|---|
| Base Duty Rate | 0.0% (Ad Valorem) |
| Section 301 Surcharge | 0.0% |
| IEEPA Surcharge | 0.0% |
| Total Effective Duty | 0.0% |
| Tax Calculation | CIF Value × 0% = $0 |
| De Minimis Exemption Eligible | ✅ Yes (If value < $800 per shipment, no duty/taxes apply; if > $800, standard 0% applies) |
| Legal Basis Path | USITC:9021.39.00.00 → No footnotes for 301/IEEPA surcharges on this specific code |
📌 Explanation:
- Unlike electronics, toys, or steel products, medical devices like breast implants are exempt from Section 301 tariffs and IEEPA surcharges in this dataset.
- The total tax is 0%, making it highly favorable for importers.
- Note: While the duty is 0%, strict regulatory compliance (FDA, CE, ISO) is still required for clearance.
🛠️ IV. Customs Clearance Practical Advice (Avoiding Pitfalls)
✅ 1. Required Documentation Checklist (All Mandatory)
| Document | Must Provide | Purpose |
|---|---|---|
| ✅ Medical Device Registration Certificate | ✔️ | FDA 510(k) or PMA approval (for US) |
| ✅ Product Specification Sheet | ✔️ | Material (silicone), size, volume, texture (smooth/rough) |
| ✅ Certificate of Analysis (COA) | ✔️ | Proof of biocompatibility and sterile packaging |
| ✅ Sterility Certificate | ✔️ | Critical for medical devices; must show gamma/e-beam sterilization |
| ✅ Commercial Invoice | ✔️ | Clearly state "Silicone Breast Implant, Medical Device, HS 9021.39.00.00" |
| ✅ Packaging List | ✔️ | Show unit count, net/gross weight, and sterile barrier integrity |
| ✅ Letter of Guarantee | ✔️ | Confirm compliance with FDA 21 CFR Part 801 (Labeling) |
✅ 2. Declaration Tips (Key Mnemonics)
🔥 "Medical Device, Not Toy, Label Sterile, HS 39 is Right!"
| Scenario | Correct Declaration | Wrong Declaration |
|---|---|---|
| Silicone Breast Implant | 9021.39.00.00 |
3926.90.99 (Plastics) → Penalty! |
| Implant Accessories (e.g., Cannula) | 9021.39.00.00 (if exclusively for implant) |
9018.90 (General medical instruments) → Risk |
| Non-Medical Silicone Doll Parts | 9021.39.00.00 (if deemed prosthetic) |
9503.00 (Toys) → Misclassification |
| Generic Silicone Tubing | 3917.21 (Flexible tubes) |
9021.39.00.00 → Wrong Scope |
📌 Warning:
- Do NOT classify breast implants under Chapter 39 (Plastics) or Chapter 95 (Toys).
- Even if the product is not yet implanted, it is considered an "artificial part of the body" under Chapter 90.
✅ 3. Special Cases Handling
| Scenario | Handling Advice |
|---|---|
| Custom/3D Printed Implants | Still 9021.39.00.00; provide FDA exemption or 510(k) if applicable |
| Sample Imports for Surgeons | Use De Minimis (<$800) if single unit; otherwise, declare as "Sample, Not for Sale" with FDA exemption form |
| Accessories Filling Kits | Declare together with implant if sold as a set; otherwise, declare separately under 9021.39.00.00 |
| Non-Sterile Implants | Cannot clear as medical device for implantation; may require re-processing or reclassification |
🌍 V. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Duty Rate | Certification Required | Notes |
|---|---|---|---|---|
| 🇺🇸 USA | 9021.39.00.00 |
0% | FDA 510(k)/PMA, Labeling | Strict enforcement on sterility |
| 🇨🇳 China | 9021.39.00.00 |
0% - 5% | NMPA Registration | Varies by province |
| 🇪🇺 EU | 9021.39.00 |
0% | CE Marking, MDR Compliance | MDR stricter than prior MDD |
| 🇬🇧 UK | 9021.39.00 |
0% | UKCA Marking, MHRA Registration | Post-Brexit rules apply |
| 🇦🇺 Australia | 9021.39.00 |
5% | TGA Registration | High regulatory barrier |
📌 Conclusion:
- USA and EU offer 0% duty for breast implants under this classification.
- Regulatory compliance (FDA/CE) is far more critical than duty rates.
- Australia has a 5% duty but maintains high safety standards.
📌 VI. Common Mistakes & Pitfalls (Lessons Learned)
❌ Mistake 1: Classifying breast implants under 3926.90.99 (Plastic articles)
👉 Consequence: Incorrect HS Code → Customs seizure, fines, and delays.
❌ Mistake 2: Omitting "Sterile" in the description
👉 Consequence: FDA rejects entry → Return to sender or destruction.
❌ Mistake 3: Mixing "Implants" with "Surgical Instruments" in one shipment
👉 Consequence: Complex inspection → Delay in clearance.
❌ Mistake 4: Not providing FDA approval number
👉 Consequence: Customs holds shipment → Storage fees accrue.
✅ Correct Approach:
"Silicone Breast Implant, Sterile, 500ml, Smooth, Medical Device, FDA 510(k) K123456, HS 9021.39.00.00"
🎯 VII. Conclusion: Precision in Classification Saves Time and Money
🎯 Remember the Mnemonic:
🔹 "Implants are Medical, Not Plastic, HS 39 is the Key!"
🔹 "Duty Zero, but Regulation High, Compliance is the Goal!"
📌 Pro Tip:
If importing samples or educational demos under $800, utilize the De Minimis exemption for streamlined entry. For commercial shipments, ensure FDA registration numbers are clearly stated on the commercial invoice and packing list.
📣 Immediate Action:
📞 Consult a licensed customs broker + Verify FDA status + Submit pre-alert documentation
🚀 Ensure zero-duty clearance while maintaining full regulatory compliance.
✨ Professional clearance starts with accurate classification!
💼 Your medical devices deserve precise handling and seamless entry!
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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。