Effective Duty Rate
0%–5.4% MFN; no Section 301
Estimate — verify by HTS code
Compliance Risk
Medium
Relative to other import corridors
Regulatory Agencies
FDA, EPA, FCC
Primary oversight bodies
OVERVIEW
Importing Medical Instruments, Devices & Diagnostic Equipment from Vietnam
Importing medical devices from Vietnam into the United States carries medium compliance risk, with an effective duty rate of 0%–5.4% MFN; no Section 301. Section 232 steel and aluminum tariffs (25% / 10%) apply to relevant medical devices sub-categories — verify your HTS code against current Section 232 annexes before entry.
Medical Devices imported from Vietnam to the United States is subject to CBP entry requirements, applicable HTS-based duty rates, and agency compliance clearances. This guide covers the complete import process for 2026.
⚠ Key Trade Intelligence — Vietnam Origin
Vietnam has growing medical device manufacturing capacity, particularly for disposable supplies. No Section 301 surcharge. FDA facility registration and quality system compliance are required.
SAMPLE LANDED COST — $50,000 SHIPMENT
Estimated Landed Cost: Medical Devices from Vietnam
Based on a representative $50,000 CIF shipment value. Actual costs vary by HTS code, entry type, and port of entry.
| Cost Component |
Amount |
Notes |
| Cargo Value (CIF) |
$50,000.00 |
Reference shipment value |
| MFN Base Duty (0.0%) |
$0.00 |
ITA or preferential rate |
| Merchandise Processing Fee (0.3464%) |
$173.20 |
Min $31.67 / max $614.35 |
| Harbor Maintenance Fee (0.125%) |
$62.50 |
Ocean freight only |
| Total Duties & Fees |
$235.70 |
Effective rate: 0.5% |
| Estimated Landed Cost |
$50,235.70 |
Cargo + all US duties/fees |
⚠ Section 232 tariffs (25% steel / 10% aluminum) may apply to medical devices sub-categories with significant steel or aluminum content. Not included above — verify by specific HTS code.
✓ ITA or preferential rates apply — base duty is 0%. MPF and HMF still apply on all entries.
Excludes freight, insurance, broker fees, warehousing, and AD/CVD duties. Use the Duty Calculator for a precise estimate on your specific shipment.
APPLICABLE HTS CODES
HTS Codes for Medical Devices Imports
The following Harmonized Tariff Schedule (HTS) codes typically apply to medical devices imports. Exact classification depends on the specific product — misclassification is one of the most common CBP compliance errors.
| HTS Code |
Product Description |
MFN Base Duty Rate |
| 9018 |
Medical, Surgical & Dental Instruments (general) |
0%–5.4% MFN |
| 9019 |
Mechano-Therapy & Massage Apparatus |
0% MFN |
| 9021 |
Orthopedic Appliances, Prostheses & Hearing Aids |
0% MFN |
| 9022 |
X-Ray & Radiation Equipment (diagnostic/therapeutic) |
0%–2.1% MFN |
| 9027 |
Instruments for Physical/Chemical Analysis (lab diagnostics) |
0%–3% MFN |
MFN rates reflect base tariff. Additional duties (Section 301, Section 232, AD/CVD) may apply on top of MFN rates. Use the AI classifier to get the exact 10-digit HTS code and all applicable rates for your specific product.
DUTY STACK — VIETNAM ORIGIN
Total Tariff Cost for Vietnam-Origin Medical Devices
| Duty Layer |
Rate / Status |
Applies To |
| MFN Base Rate |
Varies by HTS code |
All Vietnam-origin goods (baseline) |
| Section 301 |
Not applicable |
Vietnam-origin goods are not subject to Section 301 |
| Section 232 (Steel/Aluminum) |
25% steel / 10% aluminum |
Steel and aluminum imports from Vietnam |
COMPLIANCE — FDA / EPA / FCC
US Compliance Requirements for Medical Devices Imports
Regardless of origin country, medical devices imports must satisfy the following US regulatory requirements before or at the time of CBP entry filing:
- FDA 510(k) premarket notification or PMA (Premarket Approval) required — device classification (Class I, II, or III) determines regulatory pathway
- FDA Establishment Registration and Device Listing — foreign manufacturers and US importers must register with FDA annually and list all marketed devices
- FDA Unique Device Identification (UDI) labeling — medical devices must bear UDI on labels and packaging per 21 CFR Part 801
- EPA/FDA radiation-emitting product standards (21 CFR Parts 1000–1050) for X-ray, laser, ultrasound, and MRI equipment
Compliance Check Tool
Run an automated compliance check for your medical devices import — identifies all applicable agency requirements, flagging issues before your shipment departs Vietnam.
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REQUIRED DOCUMENTS
Documentation Checklist for Medical Devices from Vietnam
Prepare all documents before the shipment departs Vietnam. Missing or incorrect documents are the #1 cause of CBP holds and customs delays.
1
Commercial Invoice with device name, model, and FDA product code
3
Bill of Lading or Airway Bill
4
FDA 510(k) clearance letter or PMA approval letter
5
FDA Establishment Registration number and Device Listing confirmation
6
UDI label and GUDID (Global Unique Device Identification Database) registration
ESTIMATED TIMELINE
Import Timeline — Medical Devices from Vietnam
3–10 days (air freight for most devices); 15–30 days (ocean for heavy/bulk equipment)
Supplier Preparation
Allow 1–2 weeks for production documentation, certificates, and packing lists
Transit Time
18–35 days ocean from Asia/origin
CBP Clearance
1–3 days standard; 5–15 days if examination or AD/CVD review required
FREQUENTLY ASKED QUESTIONS
FAQs — Importing Medical Devices from Vietnam
What is the effective US tariff rate for importing medical devices from Vietnam?
The effective US tariff rate for medical devices from Vietnam is: 0%–5.4% MFN; no Section 301. Vietnam has growing medical device manufacturing capacity, particularly for disposable supplies. No Section 301 surcharge. FDA facility registration and quality system compliance are required.
What compliance agencies regulate medical devices imports from Vietnam?
Medical Devices imports require compliance with: FDA, EPA, FCC. Specific requirements include: FDA 510(k) premarket notification or PMA (Premarket Approval) required — device classification (Class I, II, or III) determines regulatory pathway and FDA Establishment Registration and Device Listing — foreign manufacturers and US importers must register with FDA annually and list all marketed devices.
What documents are required to import medical devices from Vietnam?
Required documents include: Commercial Invoice with device name, model, and FDA product code; Packing List; Bill of Lading or Airway Bill; FDA 510(k) clearance letter or PMA approval letter. Additional: FDA Establishment Registration number and Device Listing confirmation; UDI label and GUDID (Global Unique Device Identification Database) registration. Ensure all documents are prepared before the shipment departs Vietnam.
How long does customs clearance take for medical devices from Vietnam?
Typical timeline: 3–10 days (air freight for most devices); 15–30 days (ocean for heavy/bulk equipment). CBP clearance typically takes 1–3 business days for compliant entries. Complex entries (AD/CVD, formal entry review, or examination) may require 5–15 additional business days.
Are there Section 301 or Section 232 tariffs on medical devices from Vietnam?
No Section 301 tariffs apply to Vietnam-origin goods. Section 232 applies: 25% on steel and 10% on aluminum products from Vietnam.
What FDA registration and 510(k) clearance requirements apply to imported medical devices?
Medical devices imported into the US are regulated under the FD&C Act, 21 CFR Parts 800–898. Requirements vary by device class: Class I (low risk) — most require FDA registration and listing but not premarket review; Class II (moderate risk) — most require 510(k) premarket clearance demonstrating substantial equivalence to a predicate device; Class III (high risk) — require Premarket Approval (PMA). Foreign manufacturers must register with FDA and list all devices annually. FDA Import Alerts can block shipments from specific manufacturers for GMP non-compliance. All devices require labeling in English meeting 21 CFR Part 801 requirements.
What HTS codes and duty rates apply to medical device imports?
Medical devices span multiple HTS chapters. Key categories: surgical instruments (9018.11–9018.90): 0%–2.9% MFN; diagnostic imaging equipment (9022): 0%–1.2% MFN; orthopedic implants (9021): 0% MFN; hospital furniture (9402): 0%–2.4% MFN; laboratory instruments (9027): 0%–3.9% MFN; contact lenses (9001.30): 2% MFN; single-use medical products (sterile, Chapter 30): 0%–6.5% MFN. Most medical devices have low or zero MFN duty rates. However, Chinese-origin medical devices face 25% Section 301 for many categories — verify your specific HTS code against USTR lists.
How do UDI (Unique Device Identification) requirements affect medical device imports?
FDA's UDI rule (21 CFR Part 830) requires that most medical devices distributed in the US have a Unique Device Identifier on the device label and direct marking. The UDI must be submitted to FDA's Global Unique Device Identification Database (GUDID). Implementation was phased in by device class — Class III devices had earliest compliance dates, Class II and Class I followed. Importers must verify that the foreign manufacturer's UDI labeling meets FDA 21 CFR 830 requirements and that GUDID submission is current. Non-UDI-compliant devices are subject to FDA action.
Does Vietnam have a free trade agreement with the United States?
No. The US and Vietnam do not have a bilateral FTA as of 2026. TPP, which would have provided preferential access, was withdrawn by the US in 2017. IPEF (Indo-Pacific Economic Framework) includes Vietnam but does not provide tariff preferences. Vietnamese-origin goods pay standard MFN rates, which are high for textiles (17%–32%) and some manufactured goods.
Why is Vietnam a popular sourcing alternative despite high MFN tariff rates?
Vietnam's manufacturing costs are significantly lower than China's, and Vietnamese-origin goods face no Section 301 tariffs. Even at 17%–30% MFN for textiles, total landed costs from Vietnam are competitive with China's effective rates (often 35%–55% including Section 301). Vietnam is now the #2 apparel and electronics exporter to the US as supply chains diversify away from China.
What anti-circumvention risks should I be aware of when sourcing from Vietnam?
CBP actively investigates circumvention — cases where Chinese goods undergo minor processing in Vietnam to re-export under Vietnamese origin and avoid Section 301 tariffs. CBP requires genuine substantial transformation: a change of character, name, and use that would not be achieved by simple assembly, re-labeling, or minor finishing. Maintain full bills of materials and production records to defend origin claims under CBP scrutiny.
TRADE INTELLIGENCE TOOLS
Free Tools for Medical Devices Importers
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Import duty rates are sourced from the USITC Harmonized Tariff Schedule and USTR Section 301 lists. Rates reflect current published schedules as of 2026-05-16 and are subject to change. This page is for informational purposes only and does not constitute legal or customs brokerage advice. Verify rates with a licensed customs broker before importing.