Silicone Breast Implant
CN β US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 9021310000 | 10.0% | CN | US | Official Doc |
| 9021390000 | 10.0% | CN | US | Official Doc |
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π©Ί Silicone Breast Implants: HS Code Classification & Duty Analysis (2026 Latest)
π HS Code Reference & Customs Clearance Guide | 2026 Official Tariff Schedule | Professional Compliance Strategy
π 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.
β οΈ 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.
π¦ 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 | β Yes |
9021.39.00.00 |
Other artificial parts of the body and parts/accessories thereof | Silicone breast implants, cranial implants, hernia meshes | β No |
π 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.
π° III. 2026 Tariff Rate Details (Detailed Tax Breakdown)
β Applicable Country: United States (US)
β Origin: China (CN)
β Effective Date: 2025 November 10 onwards (including subsequent imports)
π― 1. 9021.39.00.00 ββ 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 Γ 0% = $0 |
| De Minimis Exemption Eligible | β Yes (If value < $800 per shipment, no duty/taxes apply; if > $800, standard 0% applies) |
| Legal Basis Path | USITC:9021.39.00.00 β No footnotes for 301/IEEPA surcharges on this specific code |
π 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.
π οΈ IV. Customs Clearance Practical Advice (Avoiding Pitfalls)
β 1. Required Documentation Checklist (All Mandatory)
| Document | Must Provide | Purpose |
|---|---|---|
| β Medical Device Registration Certificate | βοΈ | FDA 510(k) or PMA approval (for US) |
| β Product Specification Sheet | βοΈ | Material (silicone), size, volume, texture (smooth/rough) |
| β Certificate of Analysis (COA) | βοΈ | Proof of biocompatibility and sterile packaging |
| β Sterility Certificate | βοΈ | Critical for medical devices; must show gamma/e-beam sterilization |
| β Commercial Invoice | βοΈ | Clearly state "Silicone Breast Implant, Medical Device, HS 9021.39.00.00" |
| β Packaging List | βοΈ | Show unit count, net/gross weight, and sterile barrier integrity |
| β Letter of Guarantee | βοΈ | Confirm compliance with FDA 21 CFR Part 801 (Labeling) |
β 2. Declaration Tips (Key Mnemonics)
π₯ "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) β Penalty! |
| Implant Accessories (e.g., Cannula) | 9021.39.00.00 (if exclusively for implant) |
9018.90 (General medical instruments) β Risk |
| Non-Medical Silicone Doll Parts | 9021.39.00.00 (if deemed prosthetic) |
9503.00 (Toys) β Misclassification |
| Generic Silicone Tubing | 3917.21 (Flexible tubes) |
9021.39.00.00 β Wrong Scope |
π 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.
β 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 |
π V. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Duty Rate | Certification Required | Notes |
|---|---|---|---|---|
| πΊπΈ USA | 9021.39.00.00 |
0% | FDA 510(k)/PMA, Labeling | Strict enforcement on sterility |
| π¨π³ China | 9021.39.00.00 |
0% - 5% | NMPA Registration | Varies by province |
| πͺπΊ EU | 9021.39.00 |
0% | CE Marking, MDR Compliance | MDR stricter than prior MDD |
| π¬π§ UK | 9021.39.00 |
0% | UKCA Marking, MHRA Registration | Post-Brexit rules apply |
| π¦πΊ Australia | 9021.39.00 |
5% | TGA Registration | High regulatory barrier |
π 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.
π VI. Common Mistakes & Pitfalls (Lessons Learned)
β Mistake 1: Classifying breast implants under 3926.90.99 (Plastic articles)
π Consequence: Incorrect HS Code β Customs seizure, fines, and delays.
β Mistake 2: Omitting "Sterile" in the description
π Consequence: FDA rejects entry β Return to sender or destruction.
β Mistake 3: Mixing "Implants" with "Surgical Instruments" in one shipment
π Consequence: Complex inspection β Delay in clearance.
β Mistake 4: Not providing FDA approval number
π Consequence: Customs holds shipment β Storage fees accrue.
β Correct Approach:
"Silicone Breast Implant, Sterile, 500ml, Smooth, Medical Device, FDA 510(k) K123456, HS 9021.39.00.00"
π― VII. Conclusion: Precision in Classification Saves Time and Money
π― Remember the Mnemonic:
πΉ "Implants are Medical, Not Plastic, HS 39 is the Key!"
πΉ "Duty Zero, but Regulation High, Compliance is the Goal!"
π 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.
π£ Immediate Action:
π Consult a licensed customs broker + Verify FDA status + Submit pre-alert documentation
π Ensure zero-duty clearance while maintaining full regulatory compliance.
β¨ Professional clearance starts with accurate classification!
πΌ Your medical devices deserve precise handling and seamless entry!
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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.