Fresh Skin Medical Purpose
CN β US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 9021908100 | 10.0% | CN | US | Official Doc |
| 9021390000 | 10.0% | CN | US | Official Doc |
| 3001900150 | 10.0% | CN | US | Official Doc |
| 3005101000 | 10.0% | CN | US | Official Doc |
| 3005901000 | 10.0% | CN | US | Official Doc |
Product Images
AI Analysis
π©Έ Fresh Skin (Medical Purpose)
π HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Clearance Strategy
π 1. Product Definition & Classification: Do You Truly Understand "Fresh Skin"?
"Fresh Skin" in a Medical Purpose context refers to biological or tissue-based products used for wound coverage, tissue regeneration, or cosmetic/medical repair. These are highly regulated goods falling under Chapter 30 (Pharmaceutical Products) or Chapter 90 (Medical/Orthopedic Appliances).
The classification depends heavily on whether the product is considered a biological preparation, a medical dressing, or a prosthetic/orthopedic device.
β οΈ Key Distinction Point:
- If it is a biological tissue/organ preparation (e.g., skin grafts, cultured cells) βε½ε ₯ Chapter 30
- If it is a medical dressing/bandage with adhesive properties βε½ε ₯ Chapter 30 (3005)
- If it is a prosthetic/orthopedic appliance (e.g., artificial skin substitutes for reconstruction) βε½ε ₯ Chapter 90 (9021)
π¦ 2. HS Code Classification Details (2026 Latest Tariff Authority Comparison)
| HS Code | Product Description | Applicable Scenario | Key Attribute |
|---|---|---|---|
9021.90.81.00 |
Orthopedic or Fracture Appliances; Parts & Accessories | Medical repair, skin protection/repair auxiliary devices | β Orthopedic/Medical Device |
9021.39.00.00 |
Artificial Body Parts; Parts & Accessories | Artificial skin/tissue substitutes, organ replacement | β Tissue/Organ Substitute |
3001.90.01.50 |
Glands & Other Organs; Preparations Therefrom | Prepared biological treatments, tissue preparations for medical use | β Biological Preparation |
3005.10.10.00 |
Wound Dressings; Impregnated/Covered with Pharma Substances | Medical dressings with adhesive layers, bandages for wound care | β Medical Dressing |
3005.90.10.00 |
Other Wound Dressings | General medical dressings not specifically impregnated or adhesive | β General Dressing |
π Key Reminder:
- "Fresh Skin" implies biological origin. If it contains live cells or is a processed tissue,3001.90.01.50is the most accurate for biological preparations.
- If it is a dry or processed tissue substitute for reconstruction,9021.39.00.00(Artificial Body Parts) is often used for implantable/substitute tissues.
- If it is primarily a bandage/dressing (even with medical benefits),3005codes apply.
- Misclassification Risk: Do not classify complex tissue substitutes as simple dressings (3005) if they have structural implantation purposes (9021).
π° 3. 2026 Latest Tariff Rate Breakdown (Including Surtaxes, Policy Surcharges)
β Applicable Country: United States (US)
β Origin: China (CN)
β Effective Date: From November 10, 2025 (including subsequent imports)
π― 1. 9021.90.81.00 ββ Orthopedic Appliances & Parts
| Item | Content |
|---|---|
| Base Duty Rate | 0.0% (ad valorem) |
| Section 301 Surcharge | 0.0% |
| Section 122 Surcharge | +10% (Specific to certain medical/orthopedic categories under new enforcement) |
| Total Tax Rate | 10.0% |
| Tax Calculation | CIF Value Γ 10% |
| De Minimis Eligibility | β Not Eligible (Medical devices often excluded from de minimis) |
| Legal Basis Path | USITC:9021.90.81.00 β Section 122: 10% |
π Explanation:
- Although the base duty is 0%, Section 122 imposes a 10% surcharge on specific orthopedic and medical auxiliary items.
- Total Cost Impact: 10% of CIF value.
π― 2. 9021.39.00.00 ββ Artificial Body Parts
| Item | Content |
|---|---|
| Base Duty Rate | 0.0% |
| Section 301 Surcharge | 0.0% |
| Section 122 Surcharge | +10% |
| Total Tax Rate | 10.0% |
| Tax Calculation | CIF Value Γ 10% |
| De Minimis Eligibility | β Not Eligible |
| Legal Basis Path | USITC:9021.39.00.00 β Section 122: 10% |
π Note:
- Artificial skin/tissue substitutes for medical reconstruction fall under "Artificial Body Parts."
- Despite being "medical," they are subject to the 10% Section 122 surcharge, not the higher 25% Section 301 tax typically applied to consumer electronics.
π― 3. 3001.90.01.50 ββ Glands & Organs; Preparations
| Item | Content |
|---|---|
| Base Duty Rate | 0.0% |
| Section 301 Surcharge | 0.0% |
| Section 122 Surcharge | +10% |
| Total Tax Rate | 10.0% |
| Tax Calculation | CIF Value Γ 10% |
| De Minimis Eligibility | β Not Eligible |
| Legal Basis Path | USITC:3001.90.01.50 β Section 122: 10% |
π Critical Point:
- If "Fresh Skin" is defined as a biological preparation (e.g., processed tissue for grafting), this is the most precise code.
- Same 10% total rate as other medical/orthopedic categories.
π― 4. 3005.10.10.00 ββ Wound Dressings (Impregnated/Adhesive)
| Item | Content |
|---|---|
| Base Duty Rate | 0.0% |
| Section 301 Surcharge | 0.0% |
| Section 122 Surcharge | +10% |
| Total Tax Rate | 10.0% |
| Tax Calculation | CIF Value Γ 10% |
| De Minimis Eligibility | β Not Eligible |
| Legal Basis Path | USITC:3005.10.10.00 β Section 122: 10% |
π Note:
- If the product is a medical bandage with adhesive or impregnated with medicinal substances, it falls here.
- Not subject to 25% Section 301, only 10% Section 122.
π― 5. 3005.90.10.00 ββ Other Wound Dressings
| Item | Content |
|---|---|
| Base Duty Rate | 0.0% |
| Section 301 Surcharge | 0.0% |
| Section 122 Surcharge | +10% |
| Total Tax Rate | 10.0% |
| Tax Calculation | CIF Value Γ 10% |
| De Minimis Eligibility | β Not Eligible |
| Legal Basis Path | USITC:3005.90.10.00 β Section 122: 10% |
π Note:
- For general medical dressings without specific impregnation/adhesive features.
- Consistent 10% total rate.
π οΈ 4. Customs Clearance Practical Advice (Pitfall Avoidance Guide)
β 1. Required Documentation Checklist
| Document | Must Provide | Explanation |
|---|---|---|
| β Product Specification Sheet | βοΈ | Must specify: Biological vs. Synthetic, Sterilization Status, Intended Use |
| β FDA Clearance/Exemption Letter | βοΈ | Critical for medical devices/dressings. Confirm if FDA 510(k) or Exemption applies. |
| β Material Safety Data Sheet (MSDS) | βοΈ | If biological, confirm no prohibited pathogens. |
| β Commercial Invoice | βοΈ | Clearly state "Medical Purpose" and describe nature (e.g., "Processed Tissue Graft"). |
| β Certificate of Origin (CO) | βοΈ | To verify Country of Origin (China). |
| β Packing List | βοΈ | Detail items to avoid ambiguity. |
β 2. Declaration Tips (Key Mnemonics)
π₯ "Be Specific: Bio vs. Bandage, Device vs. Dressing!"
| Situation | Correct Declaration | Wrong Practice |
|---|---|---|
| Tissue Graft/Skin Substitute | "Artificial Skin Substitute for Medical Reconstruction" β 9021.39.00.00 |
"Skin Cream" or "Lotion" β Risk of rejection/fines |
| Biological Preparation | "Processed Biological Tissue Preparation for Medical Use" β 3001.90.01.50 |
"Cosmetic Product" β If used medically, this is misclassification |
| Medical Bandage | "Medical Adhesive Wound Dressing" β 3005.10.10.00 |
"Fabric Roll" β Undeclared medical purpose |
| Orthopedic Skin Protector | "Orthopedic Protective Skin Cover" β 9021.90.81.00 |
"Clothing" β Incorrect chapter |
β 3. Special Case Handling
| Situation | Handling Advice |
|---|---|
| FDA Regulated | Ensure FDA establishment registration and device listing are up-to-date. |
| Biological Origin | If from animal sources, provide Veterinary Health Certificate and Non-Transmissible Spongiform Encephalopathy (TSE) Statement. |
| Personal Use vs. Commercial | Even for personal use, medical devices often lack de minimis exemption. Declare fully. |
| Brand Name "Fresh Skin" | Clarify if "Fresh Skin" is a brand or a generic description. If generic, provide more technical details. |
π 5. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Certification Requirements | Remarks |
|---|---|---|---|---|
| πΊπΈ USA | 9021.39.00.00 or 3001.90.01.50 |
10% | FDA 510(k) or Exemption | Subject to Section 122 (10%). No 25% Section 301. |
| π¨π³ China | 9021.39.00.00 |
~5% | NMPA (National Medical Products Administration) | Higher base duty, but no surtaxes. |
| πͺπΊ EU | 9021.39.00 |
0% | CE Mark (MDR Regulation) | Zero duty, but strict MDR compliance required. |
| π¦πΊ Australia | 9021.39.00 |
~5% | TGA (Therapeutic Goods Administration) | Moderate duty, high regulatory bar. |
| π―π΅ Japan | 9021.39.00 |
0-5% | PMDA (Pharmaceuticals and Medical Devices Agency) | Low duty, strict quality standards. |
π Conclusion:
- USA is the primary market for this analysis, with a 10% total duty (Section 122).
- EU offers 0% duty but has the strictest regulatory framework (MDR) for medical devices and tissues.
- China has moderate duties but no additional surcharges.
π 6. Common Errors & Pitfall Guide (Lessons Learned)
β Error 1: Classifying "Fresh Skin" as a Cosmetic Product (e.g., 3304.99.00.00)
π Consequence: If used for medical purposes, this is fraudulent misdeclaration. Risk of seizure, fines, and FDA action.
Correct: Use Chapter 30 or 90.
β Error 2: Claiming De Minimis Exemption ($800) for Medical Devices
π Consequence: Medical devices often do not qualify for de minimis. Risk of detention, extra paperwork, and delays.
Correct: Declare fully and pay 10% duty.
β Error 3: Vague Description: "Skin Product"
π Consequence: Customs cannot determine if it's a cosmetic, dressing, or tissue. Leads to hold for inspection.
Correct: Use precise terms like "Artificial Skin Graft," "Medical Wound Dressing," or "Biological Tissue Preparation."
β Correct Practice:
"Fresh Skin, Artificial Skin Substitute for Medical Reconstruction, Sterile, FDA Exempt, Model XYZ, 10x10cm"
π― 7. Conclusion: Professional Declaration, Cost Efficiency, Smooth Clearance
π― Key Takeaways:
πΉ "Medical Purpose = Chapter 30/90, Not Cosmetics!"
πΉ "Section 122 = 10% Total Duty for Most Medical/Orthopedic Items."
πΉ "FDA Compliance is Non-Negotiable for Biological/Medical Products."
π Pro Tip:
If your "Fresh Skin" product is not implanted or does not replace body parts but is purely a dressing, use 3005 codes. If it is a tissue substitute for reconstruction, use 9021. Accuracy saves time and money!
π£ Immediate Action:
π Contact a customs broker + Provide FDA status + Use precise HS Codes (
9021.39.00.00or3001.90.01.50)
π Ensure smooth customs clearance, avoid penalties, and protect your medical brand reputation!
β¨ Professional Clearance Starts with Precise Classification!
πΌ Every dollar of duty is worth calculating accurately!
Customer Reviews
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.