Oxygen Concentrators Import Procedures – HS Codes, Duties, and Customs Clearance Process

1. Product Overview and Import Policy

An oxygen concentrator normally operates by drawing in ambient air, removing most of the nitrogen, and delivering a gas stream with a higher oxygen concentration to the user.

Common types of oxygen concentrators include:

• Home-use oxygen concentrators
• Hospital oxygen concentrators
• Low-flow oxygen concentrators
• High-flow oxygen concentrators
• Portable oxygen concentrators
• Oxygen concentrators with an integrated nebulizer function

Oxygen concentrators intended to provide oxygen for patient treatment, respiratory support, or healthcare purposes are generally regulated as medical devices.

Importers should review the following matters before importing:

• Whether the product falls within the scope of medical device regulations
• Medical device classification result
• Applicable declaration or circulation registration number
• Product name and model stated in the regulatory documents
• Manufacturer and medical device owner
• Intended use
• Vietnamese labeling and instructions for use
• Medical device business requirements
• HS classification and tax obligations

2. HS Codes for Oxygen Concentrators

2.1 Reference HS Code

Oxygen concentrators used for oxygen therapy or respiratory support are generally considered under heading 9019, which covers oxygen therapy apparatus and other therapeutic respiration apparatus.

A reference HS code is:

• 9019.20.00: Ozone therapy, oxygen therapy, aerosol therapy, artificial respiration, or other therapeutic respiration apparatus

This HS code is provided for reference only. The final classification must be determined based on the actual construction, principal function, and intended use of each product.

HS code 9019.20.00 should not automatically be applied to:

• Industrial oxygen generators
• Central oxygen generation systems
• Gas separation machinery used in factories
• Oxygen generators used in aquaculture
• Laboratory oxygen generation equipment
• Pre-filled oxygen cylinders
• Parts or accessories imported separately

2.2 How to Determine the Correct HS Code

The correct HS code should be determined based on:

• Equipment construction
• Principal function
• Power capacity
• Oxygen flow rate
• Output oxygen concentration
• Operating principle
• Intended purpose
• Intended users
• Continuous-flow or pulse-dose delivery
• Oxygen separation and concentration technology
• Included accessories
• Product catalog
• Manufacturer’s technical documents
• Instructions for use
• Medical device classification result

For example, a home-use oxygen concentrator intended to support patient breathing may be classified differently from a large-capacity industrial oxygen separation system.

Importers should prepare a detailed catalog showing the operating principle, oxygen flow rate, output concentration, intended use, and technical specifications as a basis for customs classification.

3. Import Duties and VAT

The taxes that may apply when importing oxygen concentrators include:

• Import duty
• Value-added tax

The import duty rate depends on:

• HS code accepted by customs
• Country of origin
• Tariff schedule effective on the customs declaration date
• Type of certificate of origin
• Eligibility for special preferential tariff treatment

Where the goods originate from a country or territory that has a free trade agreement with Vietnam, a special preferential import duty rate may apply if the applicable rules of origin are satisfied and a valid C/O is available.

Common certificates or proofs of origin may include:

• C/O Form E
• C/O Form D
• C/O Form AK
• C/O Form AJ
• C/O Form VJ
• C/O Form VK
• CPTPP C/O
• EVFTA proof of origin
• RCEP C/O

VAT should be determined according to the HS code, medical device documentation, and tax regulations effective when the customs declaration is registered. Importers should not automatically apply the VAT rate used for previous shipments.

Reference tax calculation formulas:

Import duty = Customs value × Import duty rate

VAT = (Customs value + Import duty) × VAT rate

** See more Nebulizer Import Procedures

4. Import Documentation

The standard customs documentation for importing oxygen concentrators normally includes:

• Customs declaration
• Commercial Invoice
• Packing List
• Sales Contract
• Bill of Lading or Air Waybill
• Certificate of Origin, if available
• Product catalog
• Technical documents
• Instructions for use

In addition to the standard customs documents, importers may need to prepare:

• Medical device classification result
• Applicable declaration or circulation registration number
• Authorization letter from the medical device owner
• Certificate of Free Sale, where required
• Manufacturer’s quality management system certificate
• Medical device technical dossier
• Vietnamese instructions for use
• Original product label
• Proposed label for circulation in Vietnam
• Warranty documentation, where applicable

Information across the documents should be consistent regarding:

• Product name
• Model
• Brand
• Manufacturer
• Medical device owner
• Country of manufacture
• Intended use
• Oxygen flow rate
• Oxygen concentration
• Power capacity
• Voltage

5. Oxygen Concentrator Import Process

Step 1: Determine the Product’s Intended Use

The importer should clearly determine whether the oxygen concentrator is intended for medical, household, industrial, laboratory, or aquaculture use. The intended purpose is an important basis for determining the applicable import policy and HS code.

Step 2: Classify the Medical Device

For oxygen concentrators intended for respiratory support, the importer should obtain or verify a medical device classification result corresponding to the actual product and model being imported.

The classification must be based on the device’s intended use, operating principle, and risk level.

Step 3: Verify the Circulation Documentation

The importer should verify whether the product has the applicable declaration or circulation registration number. The product name, model, manufacturer, medical device owner, and intended use shown in the documents must match the imported goods.

Step 4: Determine the HS Code and Taxes

The HS code should be selected based on the catalog, technical documents, oxygen separation principle, flow rate, output concentration, and intended use. Importers should also check import duties, VAT, and eligibility for preferential tariff treatment.

Step 5: Check the Product Label

The supplier should provide clear photographs of the original label before shipment. The label should contain sufficient information to identify the product, manufacturer, origin, model, and technical specifications.

Step 6: Prepare the Import Documents

The importer should verify the consistency of the Commercial Invoice, Packing List, transport document, C/O, catalog, product label, and medical device documents before the goods arrive in Vietnam.

Step 7: Submit the Customs Declaration

The customs declaration is submitted through the VNACCS system. The product description should clearly state the product name, model, intended use, operating principle, oxygen flow rate, oxygen concentration, power, voltage, manufacturer, and origin.

A reference customs description may be:

“Medical oxygen concentrator operating on the molecular sieve adsorption principle, oxygen flow rate…, oxygen concentration…, model…, power…, voltage…, brand…, manufacturer…, 100% new.”

The description should be adjusted according to the actual specifications of the imported product.

Step 8: Submit Documents and Cooperate with Customs Inspection

Depending on the customs channel, the importer may submit an electronic dossier or cooperate with a physical inspection. Customs may request additional catalogs, technical documents, classification results, or medical device circulation documents.

Step 9: Pay Taxes and Complete Customs Clearance

After fulfilling tax obligations and applicable regulatory requirements, the importer may complete customs clearance and collect the goods.

Step 10: Apply a Vietnamese Supplementary Label

Before the product is placed on the Vietnamese market, a Vietnamese supplementary label must be applied if the original label does not contain all mandatory information in Vietnamese.

6. Important Notes When Importing Oxygen Concentrators

6.1 Product-Related Notes

Importers should pay attention to the following:

• Distinguish medical oxygen concentrators from industrial oxygen generators
• Do not use the classification documents of a different model
• Verify the validity of the circulation registration
• Confirm the correct name and address of the manufacturer
• Identify the oxygen flow rate and output concentration clearly
• Prepare catalogs showing the oxygen separation principle
• Declare the intended use and technical specifications accurately
• Avoid using a vague description such as “gas-generating machine”
• Check the import policy for accessories imported separately

Common accessories may include:

• Oxygen tubing
• Nasal cannula
• Oxygen mask
• Humidifier bottle
• Air filter
• Nebulizer cup
• Power adapter
• Battery
• Charger
• Remote control

Accessories imported separately may have different HS codes and regulatory requirements from the complete oxygen concentrator.

6.2 Labeling Requirements

The product label should include:

• Product name
• Manufacturer
• Manufacturer’s address
• Country of origin
• Brand
• Model
• Serial number, if available
• Lot number, if available
• Power capacity
• Voltage
• Frequency
• Oxygen flow rate
• Output oxygen concentration
• Output pressure
• Noise level, if applicable
• Main technical specifications
• Safety warnings
• Storage conditions

The Vietnamese supplementary label should provide the name and address of the entity responsible for the product in Vietnam, intended use, instructions, warnings, and other mandatory information not already presented in Vietnamese on the original label.

6.3 Used Oxygen Concentrators

For used oxygen concentrators, importers should review:

• Year of manufacture
• Equipment age
• Model
• Serial number
• Manufacturing standards
• Remaining quality
• Previous operating time
• Maintenance condition
• Oxygen generation capability
• Actual output oxygen concentration
• Inspection certificate
• Import conditions for used medical devices

Used oxygen concentrators should not be shipped to Vietnam until their import eligibility and compliance with applicable safety and quality requirements have been confirmed.

** See more Procedures for importing infusion pumps

7. Oxygen Concentrator Import Services

A customs and logistics service provider may support importers with:

• Import policy review
• Medical device classification consultation
• Verification of circulation registration
• Reference HS code consultation
• Import duty and VAT review
• C/O verification
• Review of the Commercial Invoice and Packing List
• Review of catalogs and technical documents
• Product label review
• Preparation of customs documentation
• Customs declaration
• Coordination of physical inspection
• Customs clearance
• Delivery to the importer’s warehouse

Because medical oxygen concentrators are subject to specialized regulatory documentation, importers should review the product dossier before confirming the purchase order and before the supplier ships the goods.

8. FAQ – Frequently Asked Questions About Oxygen Concentrator Imports

8.1 Is an Import License Required for Oxygen Concentrators?

A separate import license is not required for every shipment. The importer should review the medical device classification, circulation registration, and intended import purpose to determine the applicable requirements.

8.2 Is an Oxygen Concentrator Considered a Medical Device?

An oxygen concentrator intended to provide oxygen for patient treatment, respiratory support, or healthcare purposes is generally managed as a medical device. Industrial oxygen generators or equipment intended for other purposes may be subject to different regulations.

8.3 What Is the HS Code for an Oxygen Concentrator?

A reference HS code is 9019.20.00 for certain oxygen therapy or therapeutic respiration apparatus. The final HS code depends on the product’s construction, principal function, operating principle, and intended use.

8.4 What Is the Import Duty on Oxygen Concentrators?

The applicable import duty depends on the HS code, country of origin, and certificate of origin. Importers should review the tariff schedule effective when the customs declaration is registered.

8.5 Is a Product Catalog Required?

Yes. A product catalog helps customs and regulatory authorities verify the operating principle, oxygen flow rate, output concentration, intended use, HS code, and medical device policy.

8.6 How Long Does Customs Clearance Take?

The customs clearance time depends on the customs channel, completeness of the documentation, validity of the circulation registration, and whether a physical inspection is required.

8.7 Can Used Oxygen Concentrators Be Imported into Vietnam?

The importer must separately review the regulations applicable to used medical devices and used machinery. The goods should not be shipped until the equipment age, remaining quality, inspection documentation, and import eligibility have been confirmed.

9. Conclusion

Oxygen concentrator import procedures require businesses to comply with both customs regulations and medical device management requirements. Before importing, the business should verify the intended use, medical device classification, circulation documentation, HS code, applicable taxes, and labeling requirements.

HS code 9019.20.00 may be used as a reference for certain oxygen concentrators intended for oxygen therapy or respiratory support. However, the final classification must be based on the construction, principal function, capacity, operating principle, intended use, catalog, and technical documents of each specific model.

Reviewing the product documentation before shipment can help prevent incorrect HS classification, missing medical device documents, labeling discrepancies, customs delays, and additional storage charges.