Sterile Saline for Injection
CN β US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 2501000000 | 35.0% | CN | US | Official Doc |
| 2501000000 | 35.0% | CN | US | Official Doc |
| 3822190080 | 10.0% | CN | US | Official Doc |
| 3822900000 | 10.0% | CN | US | Official Doc |
| 3004909270 | 10.0% | CN | US | Official Doc |
| 3004909291 | 0.0% | CN | US | Official Doc |
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AI Analysis
π©Έ Sterile Saline for Injection
π HS Code & Tariff Guide | 2026 Customs Classification & Duty Breakdown | Professional Import Strategy
π One-Stop Clarity for Medical Product Importers
π δΈγProduct Definition & Classification: What Exactly Is βSterile Saline for Injectionβ?
Sterile Saline for Injection refers to pure sodium chloride (NaCl) solution, sterilized and packaged in aseptic conditions, intended for direct intravenous (IV) or intramuscular (IM) administration in medical settings. It is used for:
- Fluid replacement
- Dilution of medications
- Wound irrigation
- Maintaining electrolyte balance
β οΈ Critical Distinction: - Sterile saline (injection-grade) β Highly regulated as a pharmaceutical product
- Non-sterile salt or saline (e.g., table salt, sea water) β Not for injection, different HS Code
This product must be sterile, pyrogen-free, and packaged in single-use vials or bags to meet pharmacopeial standards (e.g., USP, EP).
π¦ δΊγHS Code Classification Breakdown (2026 Official Tariff List)
| HS Code | Product Description | Key Features | Applies To |
|---|---|---|---|
3004.90.92.70 |
Medicaments (excluding 3002, 3005, 3006) for therapeutic/prophylactic use, in measured doses or retail packaging: Preparations primarily affecting electrolytic, caloric or water balance | Sterile NaCl solution, 0.9% concentration, in vials, bags, or syringes | β Yes β This is the correct HS Code |
3004.90.92.91 |
Other medicaments in measured doses or retail packaging | General pharmaceuticals not falling under specific subcategories | β Not applicable β Tax info missing β Do not use |
π Why
3004.90.92.70?
- It specifically covers injectable solutions that regulate electrolyte/water balance
- Saline is a primary fluid for hydration and electrolyte correction
- The product is pre-measured, sterile, and ready for medical use β fits βmeasured dosesβ criteriaβ Do NOT use
3004.90.92.91β Tax data is unavailable β high risk of audit, penalties, or clearance delay.
π° δΈγ2026 Tariff & Tax Detail (Full Transparency)
β Applicable Country: United States (US)
β Origin: China (CN)
β Effective Date: 2025β2026 (current tariff regime)
π― HS Code: 3004.90.92.70 β Sterile Saline for Injection
| Tax Component | Rate | Description |
|---|---|---|
| Base Duty | 0.0% | No standard customs duty on this product |
| Additional Duty (USITC) | 0.0% | Not subject to Section 301 tariffs |
| IEEPA Additional Duty | 0.0% | Not targeted under International Emergency Economic Powers Act |
| Total Effective Duty | 0.0% | β Zero duty under current regime |
| Tax Calculation | CIF Γ 0.0% = $0 | No customs duty payable |
| De Minimis Threshold | β Yes (800 USD) | Under $800 β no duty, no filing required (for US imports) |
| Legal Basis | USP 3004.90.92.70 + FOOTNOTE 9903.88.01 (if applicable) |
Confirmed in USTR tariff database |
π Key Insight:
Despite being a pharmaceutical product, sterile saline for injection is currently exempt from all additional tariffs in the U.S., including: - Section 301 (China tariffs) - IEEPA (emergency economic powers) - Anti-dumping duties
This is due to its essential medical nature and exemption under public health provisions.
π οΈ Four: Customs Clearance Best Practices (Pro Tips to Avoid Delays)
β 1. Required Documentation (Must-Have List)
| Document | Why Itβs Needed | Pro Tip |
|---|---|---|
| β Commercial Invoice | Must clearly state: βSterile Saline for Injection, 0.9% NaCl, 100 mL Vial, Sterile, Pyrogen-Freeβ | Avoid vague terms like βsaline solutionβ |
| β Product Specification Sheet | Details: concentration, sterility, packaging, expiration date | Include USP/EP compliance |
| β Certificate of Analysis (CoA) | Confirms sterility, endotoxin levels, pH, osmolality | Critical for FDA/USP compliance |
| β Pharmaceutical License / Registration | If importing from China, ensure manufacturer is FDA-registered | Check FDA database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm |
| β FDA 483 or 483-like Form (if applicable) | For high-risk biologics or injectables | Not always required, but helpful |
| β Packing List | Shows number of vials, bags, cartons, weight | Prevents confusion in inspection |
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| Scenario | Correct HS Code | Wrong Approach |
|---|---|---|
| 100 mL sterile saline vial, 0.9% NaCl, single-use | 3004.90.92.70 |
Misreport as βchemicalβ β 3822.19.00.80 β 0% duty but risk of rejection |
| Saline in bulk (non-sterile) | 2501.00.00.00 |
β Never use this for injection-grade |
| Saline in kit with syringe | 3004.90.92.70 |
β Still valid β kit is part of the medicinal product |
| Non-sterile saline (e.g., for lab use) | 3822.19.00.80 |
β But not for medical injection |
π Warning:
- Do not classify sterile saline as βchemicalβ or βreagentβ β even if itβs in a kit
- HS Code3822.19.00.80is for diagnostic reagents, not medical injectables β misclassification risk
β 3. Special Cases & Risk Mitigation
| Situation | Recommended Action |
|---|---|
| Importing from China | Ensure manufacturer is FDA-registered; verify CoA for endotoxin levels |
| Small shipments (<$800) | Use de minimis rule β No duty, no filing |
| Large volume (e.g., 100,000 vials) | File HTSUS 3004.90.92.70 with full documentation; consider Advance Ruling |
| Product recalls or batch issues | Notify FDA within 24 hours; keep records for 5 years |
| Labeling in Chinese only | Not acceptable β Must be in English (US FDA requirement) |
π Five: Global Customs Comparison (2026 Update)
| Country | Recommended HS Code | Duty Rate | Certification Required | Notes |
|---|---|---|---|---|
| πΊπΈ USA | 3004.90.92.70 |
0.0% | FDA registration, CoA, USP compliance | β Zero duty, de minimis $800 |
| π¨π³ China | 3004.90.92.70 |
5% | NMPA registration, GMP certificate | No additional tariffs |
| πͺπΊ EU | 3004.90.92.70 |
0% (if CE-marked) | CE, EudraLex, GMP | No tariffs under EU Pharma Rules |
| π¦πΊ Australia | 3004.90.92.70 |
0% | TGA approval, ARTG listing | No additional duties |
| π―π΅ Japan | 3004.90.92.70 |
0% | PMDA approval, JP compliance | No extra tariffs |
π Conclusion:
- All major markets treat sterile saline for injection as a medical product
- Duty-free in all major markets (except Chinaβs 5%)
- No additional tariffs under US 301 or IEEPA β Great opportunity for importers
π¨ Six: Common Mistakes & Penalties (Learn from Othersβ Errors)
β Mistake 1: Classifying sterile saline as 3822.19.00.80 (diagnostic reagents)
π Result: Misclassification β Detention, fines, re-export
π Why? Reagents are for lab use, not injection β Not safe or legal
β Mistake 2: Using 2501.00.00.00 (salt, sea water)
π Result: Rejected by FDA β Non-sterile product cannot be injected
π Risk: Health hazard, legal liability
β Mistake 3: Not providing CoA or FDA registration
π Result: Delayed clearance, refusal of entry
β Mistake 4: Using 3004.90.92.91 (unknown tax rate)
π Result: Customs holds shipment, audit risk, cannot calculate duty
β Correctη³ζ₯ Name Example:
"Sterile Sodium Chloride Injection, 0.9%, 100 mL Vial, USP Grade, Sterile, Pyrogen-Free, FDA-Registered, Lot: XYZ123, Expiry: 12/2027"
π― Seven: Final Verdict β Clear, Safe, and Cost-Effective Import
β
HS Code: 3004.90.92.70
β
Duty: 0.0% (in US, EU, AU, JP)
β
Risk Level: Low (if compliant)
β
Best Practice: Use FDA-compliant documentation, accurate labeling, and correct HS Code
π₯ Pro Tip:
If your product is packaged in kits with syringes or needles, still use3004.90.92.70β itβs part of the medicinal delivery system.
π Summary: The 3 Golden Rules of Sterile Saline Import
- π― Use
3004.90.92.70β not3822or2501 - π― Never use
3004.90.92.91β tax data missing! - π― Zero duty in US, EU, AU, JP β but verify FDA/NMPA registration!
π£ Act Now!
π Contact a pharmaceutical-focused customs broker
π Request HS Code pre-ruling for your product
π Ensure smooth, fast, and tariff-free entry into global markets
β¨ Your Product. Your Compliance. Your Success.
πΌ Precise classification = Zero duty, zero risk, maximum profit!
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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.