Nebulizer Import Procedures – HS Codes, Duties, and Customs Clearance Process

1. Product Overview and Import Policy

A nebulizer is a device that converts liquid medicine or solution into an aerosol for delivery into the respiratory tract through a mask or mouthpiece.

Common types of nebulizers include:

• Compressor nebulizers
• Ultrasonic nebulizers
• Vibrating mesh nebulizers
• Portable nebulizers
• Home-use nebulizers
• Nebulizers used in healthcare facilities

Nebulizers intended to deliver medicine or support respiratory treatment are generally managed as medical devices. Depending on their intended use, operating principle, design, and risk level, they may be classified into the relevant medical device risk category.

Importers should review the following matters before arranging shipment:

• Whether the product falls within the scope of medical device regulations
• Medical device classification result
• Applicable declaration or circulation registration number
• Product model and manufacturer stated in the regulatory documents
• Eligibility of the entity holding the circulation registration
• Vietnamese labeling and instructions for use
• Customs classification and tax obligations

2. HS Codes for Nebulizers

2.1 Reference HS Code

Nebulizers used to generate aerosols for respiratory therapy are commonly considered under heading 9019.

A reference HS code is:

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

HS code 9019.20.00 is provided for reference only. Importers should not automatically apply this code to every product described as a nebulizer or inhalation machine.

Products that may be classified differently include:

• Ordinary steam generators
• Air humidifiers
• Facial steamers
• Essential oil diffusers
• Personal steam inhalers
• Multifunctional therapeutic devices

2.2 How to Determine the Correct HS Code

The correct HS code should be determined based on:

• Product construction
• Principal function
• Power capacity
• Operating principle
• Intended purpose
• Type of liquid or medicine used
• Aerosol particle size
• Nebulization rate
• Intended users
• Included accessories
• Product catalog
• Manufacturer’s technical documents
• Instructions for use
• Medical device classification result

For example, a compressor nebulizer that converts medicine into fine aerosol particles for respiratory treatment may be classified differently from a hot steam inhaler or an air humidifier.

Importers should obtain a detailed catalog showing the nebulization principle, intended use, technical specifications, and product images. These documents provide an important basis for customs classification.

3. Import Duties and VAT

The taxes that may apply when importing nebulizers 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 products 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 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 because tax policies may change.

Reference tax calculation formulas:

Import duty = Customs value × Import duty rate

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

** See more Electronic Thermometers Import Procedures

4. Import Documentation

The standard customs documentation 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 as part of the registration dossier
• Manufacturer’s quality management system certificate
• Medical device technical dossier
• Vietnamese instructions for use
• Original product label
• Proposed label for circulation in Vietnam

Information across the documents should be consistent regarding:

• Product name
• Model
• Brand
• Manufacturer
• Medical device owner
• Country of manufacture
• Intended use
• Technical specifications

5. Nebulizer Import Process

Step 1: Determine the Product’s Intended Use

The importer should clearly determine whether the product is a medical nebulizer, steam inhaler, facial steamer, or air humidifier. Products with different intended uses may be subject to different HS codes and regulatory requirements.

Step 2: Classify the Medical Device

The product should be classified according to its intended use, operating principle, and risk level. The classification result must correspond to the actual product and model being imported.

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, owner, and intended use shown in the regulatory documents must match the imported goods.

Step 4: Determine the HS Code and Taxes

The HS code should be selected based on the product catalog, technical documents, construction, operating principle, and intended use. The importer 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, and main 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 shipment arrives 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, capacity, voltage, manufacturer, and origin.

A reference customs description may be:

“Medical nebulizer operated by an air compressor, model…, power…, voltage…, brand…, manufacturer…, 100% new.”

The description should be adjusted to reflect 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 registration 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 Nebulizers

6.1 Product-Related Notes

Importers should pay attention to the following:

• Distinguish medical nebulizers from ordinary steam 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
• Prepare catalogs showing the operating principle
• Declare the intended use and technical specifications clearly
• Avoid using a vague description such as “inhalation machine”
• Check the import policy for separately imported accessories

Common accessories may include:

• Adult mask
• Child mask
• Air tube
• Medicine cup
• Mouthpiece
• Air filter
• Power adapter
• Battery or charger

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

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
• Power source
• Nebulization rate
• Aerosol particle size, 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.

** See more Procedures for importing infusion pumps

7. Nebulizer 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
• Product label review
• Preparation of customs documentation
• Customs declaration
• Coordination of physical inspection
• Customs clearance
• Delivery from the port or airport to the importer’s warehouse

Because nebulizers may be regulated as medical devices, the product documents should be reviewed before the purchase order is confirmed and before the supplier ships the goods.

8. FAQ – Frequently Asked Questions About Nebulizer Imports

8.1 Is an Import License Required for Nebulizers?

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

8.2 Is a Nebulizer Considered a Medical Device?

A nebulizer intended to convert medicine into an aerosol for respiratory treatment is generally managed as a medical device. Steam generators and air humidifiers may be subject to different policies.

8.3 What Is the HS Code for a Nebulizer?

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

8.4 What Is the Import Duty on Nebulizers?

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 catalog is an important document for verifying the product’s intended use, operating principle, technical specifications, HS classification, and medical device policy.

8.6 How Long Does Customs Clearance Take?

The 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 Nebulizers Be Imported into Vietnam?

The importer must separately review the regulations applicable to used medical devices and used machinery. Used products should not be shipped to Vietnam until their remaining quality, age, regulatory status, and import eligibility have been confirmed.

9. Conclusion

Nebulizer import procedures require importers 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 nebulizers used in respiratory therapy. However, the final classification must be based on the construction, principal function, 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.

If you have difficulties when clearing customs, you can choose Just In Time as a companion.

Just In Time's staff is always enthusiastic to support you to handle your work quickly and professionally.

 

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