Silicone Pig
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π· Silicone Pig (Medical Grade Silicone Implant)
π HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Compliance Strategy
π I. Product Definition & Classification: Do You Truly Understand "Silicone Pig"?
In the context of international trade, "Silicone Pig" is a colloquial or mistranslated term. It almost universally refers to Medical Grade Silicone Implants (specifically Breast Implants or Soft Tissue Fillers) used for reconstructive surgery or cosmetic enhancement. It is NOT a living animal, nor is it a toy.
For customs purposes, these are classified as Medical Devices or Articles of Plastics, depending on their specific regulatory status in the importing country. However, for US Customs (CBP), they are primarily regulated as Medical Devices.
β οΈ Critical Distinction:
- If it is a finished, sterile, implantable device intended for human use β Chapter 90 (Medical Instruments).
- If it is raw silicone material or non-medical silicone parts (e.g., for molds, toys) β Chapter 40 (Rubber/Plastics).
- β WARNING: Misclassifying medical implants as general plastic goods can lead to FDA seizures, heavy fines, and import bans.
π¦ II. HS Code Classification Details (2026 Official Tariff Schedule)
| HS Code | Product Description | Application Scenario | Regulatory Status |
|---|---|---|---|
9021.21.00.00 |
Breast implants, artificial parts of the body | Cosmetic surgery, reconstructive surgery | FDA Regulated (Class III Device) |
9021.39.00.00 |
Other artificial parts of the body (e.g., joint replacements, bone plates) | Orthopedic surgery | FDA Regulated |
4016.93.00.00 |
Other articles of cellular rubber (non-medical) | Industrial seals, gaskets, non-implantable silicone parts | Standard Duty |
3926.90.97.90 |
Other articles of plastics (non-medical) | Silicone toys, household items, non-sterile components | Standard Duty |
9018.90.00.00 |
Instruments and appliances used in medical, surgical, dental, or veterinary sciences | Surgical tools, syringes, diagnostic devices | FDA Regulated |
π Key Focus:
-9021.21.00.00is the primary HS Code for silicone breast implants.
- If the product is not implantable (e.g., a silicone doll part, a mold, a toy), it may fall under4016.93or3926.90, but must be clearly described as non-medical and non-sterile to avoid FDA confusion.
π° III. 2026 Latest Tariff Rate Details (Including Surtaxes & Policy Add-ons)
β Applicable Country: United States (US)
β Origin: China (CN)
β Effective Time: November 10, 2025 onwards
π― 1. 9021.21.00.00 ββ Breast Implants (Silicone)
| Item | Content |
|---|---|
| Base Duty Rate | 0% (Most Favored Nation) |
| USITC Surtax (Section 301) | +7.5% (Footnote 9903.88.01 applies to many medical devices if not exempt) |
| IEEPA Surtax (China) | +10% (Under E.O. 14117, effective Nov 2025) |
| Total Tariff Rate | 17.5% |
| Tax Calculation | CIF Value Γ 17.5% |
| De Minimis Exemption | β Not Applicable (Medical devices are generally excluded from $800 de minimis) |
| Legal Path | IEEPA:9903.01.24 β USITC:9021.21.00.00 β FOOTNOTE:9903.88.01 |
π Explanation:
- While the base duty is 0%, the Section 301 and IEEPA surtaxes apply to many Chinese-origin medical devices unless specifically exempted.
- Note: Some medical devices may be exempt from Section 301 if they are not available in sufficient quantities in the US. However, you must apply for an exclusion.
- Total Cost Impact: Even at 17.5%, the value of medical devices is high, making tariff optimization critical.
π― 2. 4016.93.00.00 ββ Other Cellular Rubber Articles (Non-Medical Silicone)
| Item | Content |
|---|---|
| Base Duty Rate | 3.7% (General) |
| USITC Surtax (Section 301) | +25% |
| IEEPA Surtax (China) | +10% |
| Total Tariff Rate | 38.7% |
| De Minimis Exemption | β Not Applicable for high-value batches |
| Legal Path | IEEPA:9901.25 β USITC:4016.93.00.00 β FOOTNOTE:9903.88.01 |
π Note: If your "silicone pig" is actually a toy or industrial part, the tariff is significantly higher due to lack of medical exemptions.
π οΈ IV. Customs Clearance Practical Advice (Battle-Tested Pitfall Guide)
β 1. Documentation Checklist (Non-Negotiable)
| Document | Required? | Description |
|---|---|---|
| β FDA Establishment Registration | βοΈ | Supplier must be FDA-registered |
| β FDA Product Listing | βοΈ | Each product must be listed with FDA |
| β 510(k) Clearance Number | βοΈ | If applicable (for breast implants, usually PMA approved) |
| β Certificate of Free Sale | βοΈ | From the country of origin |
| β Sterility Certificate | βοΈ | If marketed as sterile |
| β Commercial Invoice | βοΈ | Must clearly state "Silicone Breast Implants, Class III Medical Device, FDA Approved" |
| β Packing List | βοΈ | Detailing lot numbers, expiration dates |
| β Importer Statement | βοΈ | Confirming compliance with FDA regulations |
β 2. Declaration Tips (Key Mantra)
π₯ "Medical Device First, FDA Number Second, HS Code Third, Mislabeling is Death!"
| Scenario | Correct Declaration | Wrong Practice |
|---|---|---|
| Silicone Breast Implant | 9021.21.00.00 + FDA PMA Number |
Declare as 4016.93 (Rubber) β FDA Seizure |
| Silicone Mold (Non-medical) | 4016.93.00.00 + "Non-medical, Non-sterile, For Industrial Use" |
Declare as 9021.21 β Unnecessary FDA Check |
| Silicone Doll Part | 4016.93.00.00 + "Toy Component, Not for Implantation" |
Vague description "Silicone Part" β Customs Hold |
β 3. Special Situation Handling
| Situation | Handling Advice |
|---|---|
| OEM Medical Device | Provide FDA registration numbers of both manufacturer and importer. |
| Non-Implantable Silicone Product | Clearly label as "NOT FOR HUMAN IMPLANTATION", "NON-STERIC", "INDUSTRIAL USE ONLY" on packaging and invoice. |
| Mixed Shipment (Medical + Non-Medical) | Split shipments or clearly separate on invoice. Mixed clearance causes massive delays. |
| FDA Inspection Risk | Ensure lot numbers match physical products. FDA conducts targeted inspections of high-risk imports. |
π V. Global Market Customs Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Certification Requirements | Notes |
|---|---|---|---|---|
| πΊπΈ USA | 9021.21.00.00 |
17.5% | FDA (PMA/510k) | Strict enforcement |
| π¨π³ China | 9021.21.00.00 |
0-6% | NMPA (China FDA) | Requires NMPA Registration |
| πͺπΊ EU | 9021.21.00.00 |
0% | CE Marking (MDR Regulation) | Very strict post-market surveillance |
| π¦πΊ Australia | 9021.21.00.00 |
5% | TGA Registration | Mandatory for implantables |
| π―π΅ Japan | 9021.21.00.00 |
0% | PMDA Approval | Long approval process |
π Conclusion:
- USA and EU have the strictest regulatory barriers.
- Tariff is secondary to Compliance. If you lack FDA/CE approval, you cannot legally import medical-grade silicone implants.
π VI. Common Mistakes & Pitfall Guide (Blood & Tears Lessons)
β Mistake 1: Declaring Breast Implants as "Silicone Parts" or "Plastic Articles"
π Consequence: FDA Detention, Seizure, Deportation, $10,000+ Fines per shipment.
β Mistake 2: Using De Minimis ($800) for Medical Devices
π Consequence: Illegal. Medical devices are excluded from de minimis. Your shipment will be held until proper documentation is provided.
β Mistake 3: Omitting FDA Registration Numbers on the Invoice
π Consequence: Customs will reject the entry, causing storage fees and delays.
β Mistake 4: Confusing "Medical Grade" with "Food Grade" or "Toy Grade"
π Consequence: If you intend to sell as medical but use toy-grade silicone, you face fraud charges and product liability lawsuits.
β Correct Practice:
"Silicone Breast Implant, Class III Medical Device, FDA PMA Approved, Lot #XYZ, Expiry: 2028-12-31, Not for Human Use if Damaged"
π― VII. Conclusion: Precision Compliance Saves Lives and Money
π― Remember the Mantra:
πΉ "Medical Device = FDA First, HS Code Second."
πΉ "Silicone Pig is not a toy; it's a high-risk medical import."
πΉ "Misclassification leads to seizure, not savings."
π Pro Tip:
If your product is NOT for human implantation (e.g., a silicone mold, a doll, a toy), ensure your commercial invoice and product labeling explicitly state:
"NOT A MEDICAL DEVICE. NOT FOR HUMAN IMPLANTATION. FOR INDUSTRIAL/TOY USE ONLY."
This allows you to potentially classify under4016.93or3926.90, avoiding FDA scrutiny and lower tariffs.
π£ Immediate Action:
π Verify FDA Registration Status + Confirm HS Code with Customs Broker + Ensure Labeling Compliance
π Clear, compliant, and cost-effective import starts with accurate classification!
β¨ Professional Customs Clearance, Starting with Precise Classification!
πΌ Your Compliance is Your Competitiveness!
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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.