Electrocardiograph (ECG Machine) Import Procedures – HS Codes, Duties, and Customs Clearance Process

Electrocardiograph (ECG Machine) Import Procedures – HS Codes, Duties, and Customs Clearance Process

Electrocardiograph (ECG Machine) Import Procedures – HS Codes, Duties, and Customs Clearance Process

Posted on: 10/08/2026

An electrocardiograph, commonly known as an ECG or EKG machine, is a medical device used to record the electrical activity of the heart through electrodes attached to the patient’s body. ECG machines are widely used in hospitals, clinics, cardiology centers, and other healthcare facilities. When importing ECG machines into Vietnam, businesses should carefully review medical device classification, circulation documentation, HS classification, tax obligations, and labeling requirements before shipment.

Electrocardiograph

1. Product Overview and Import Policy

Common types of ECG machines include:

  • 1-channel ECG machines
  • 3-channel ECG machines
  • 6-channel ECG machines
  • 12-channel ECG machines
  • Portable ECG machines
  • Desktop ECG machines
  • ECG machines with touchscreens
  • ECG machines with integrated thermal printers
  • Computer-connected ECG systems
  • ECG machines with automatic interpretation functions
  • Holter ECG systems
  • Exercise or stress ECG systems

An ECG machine is intended to record and analyze the electrical activity of the heart and therefore falls within the scope of medical device regulations.

Before importing, businesses should check:

  • Intended use of the device
  • Number of ECG channels
  • Number of leads
  • Recording and analysis functions
  • Automatic interpretation capability
  • Whether the device includes Holter functions
  • Whether the device is integrated into a patient monitoring system
  • Medical device classification result
  • Applicable declaration or circulation registration number
  • Product model
  • Manufacturer
  • Medical device owner
  • Product labeling requirements
  • HS classification
  • Import duty and VAT

2. HS Codes for ECG Machines

2.1 Reference HS Classification

ECG machines are generally considered under heading 9018, covering instruments and appliances used in medical, surgical, dental, or veterinary sciences.

A reference subheading is:

  • 9018.11: Electrocardiographs and parts and accessories thereof

The importer should determine the complete 8-digit HS code according to the Vietnamese tariff schedule effective when the customs declaration is registered.

The same HS code should not automatically be applied to every device capable of measuring or displaying cardiac signals.

Importers should distinguish between:

  • Standard ECG machines
  • Holter ECG recorders
  • Multiparameter patient monitors
  • Exercise ECG systems
  • Heart-rate monitors
  • Wearable ECG devices
  • Remote cardiac monitoring equipment
  • Multifunction ECG systems
  • ECG cables and electrodes imported separately

2.2 Distinguishing ECG Machines from Patient Monitors

The principal functions of an ECG machine generally include:

  • Acquiring electrical signals from the heart
  • Displaying ECG waveforms
  • Recording electrocardiograms
  • Printing ECG results
  • Analyzing ECG parameters

A multiparameter patient monitor may simultaneously monitor:

  • ECG
  • SpO2
  • Blood pressure
  • Respiration
  • Temperature
  • EtCO2
  • Other vital signs

Therefore, a multiparameter patient monitor should not automatically be classified as an electrocardiograph simply because it incorporates an ECG module.

2.3 How to Determine the Correct HS Code

The HS code should be determined based on:

  • Product construction
  • Principal function
  • Operating principle
  • Number of ECG channels
  • Number of leads
  • Continuous recording capability
  • Data storage capability
  • ECG interpretation functions
  • Integrated printer
  • Network connectivity
  • Computer connectivity
  • Holter functions
  • Patient-monitoring functions
  • Product catalog
  • Technical documents
  • Instructions for use
  • Medical device documentation

The product catalog should clearly state the number of channels, leads, recording modes, analysis functions, storage capability, and included modules.

3. Import Duties and VAT

The taxes that may apply when importing ECG machines include:

  • Import duty
  • Value-added tax

The applicable rates depend on:

  • HS code accepted by customs
  • Country of origin
  • Tariff schedule effective on the customs declaration date
  • Certificate or proof of origin
  • Eligibility for special preferential tariff treatment
  • Tax treatment applicable to medical devices at the time of importation

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 relevant rules of origin are satisfied and valid origin documentation 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 based on the HS code, medical device documentation, and tax regulations effective when the customs declaration is registered.

Reference tax calculation formulas:

Import duty = Customs value × Import duty rate

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

Importers should not automatically apply tax rates used for previous shipments without reviewing the current tariff and medical device tax policy.

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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

Because ECG machines are medical devices, the importer may also 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 applicable
  • Manufacturer’s quality management system certificate
  • Medical device technical dossier
  • Vietnamese instructions for use
  • Warranty documentation
  • Original product label
  • Proposed Vietnamese supplementary label
  • Electrical safety documentation
  • Performance documentation

Information across the documents should be consistent regarding:

  • Product name
  • Model
  • Brand
  • Manufacturer
  • Medical device owner
  • Country of manufacture
  • Intended use
  • Number of channels
  • Number of leads
  • Power capacity
  • Voltage
  • Included accessories

5. ECG Machine Import Process

Step 1: Determine the Exact Type of Device

The importer should determine whether the product is a standard ECG machine, Holter ECG recorder, exercise ECG system, or multiparameter patient monitor incorporating ECG functionality.

Step 2: Review Medical Device Classification

The medical device classification should be reviewed based on the intended use, operating principle, and applicable risk classification rules.

The classification assigned to one ECG product should not automatically be applied to another model with different functions or intended use.

Step 3: Verify Circulation Documentation

The following information on the regulatory documentation should correspond to the imported goods:

  • Product name
  • Model
  • Manufacturer
  • Medical device owner
  • Intended use

Step 4: Determine the HS Code

The HS code should be selected based on:

  • Principal function
  • Product construction
  • Number of channels
  • Number of leads
  • Analysis capabilities
  • Integrated functions
  • Technical documentation

Step 5: Check Import Duties and C/O

The importer should verify:

  • Import duty
  • VAT
  • Country of origin
  • Certificate of Origin
  • Eligibility for special preferential tariff treatment

Step 6: Check the Product Label

The supplier should provide clear photographs of the original product label before shipment.

The label should generally show:

  • Product name
  • Model
  • Serial number
  • Manufacturer
  • Country of origin
  • Voltage
  • Frequency
  • Power capacity
  • Main technical specifications

Step 7: Submit the Customs Declaration

The customs declaration should clearly describe the function and configuration of the ECG machine.

A reference description for a 12-channel ECG machine may be:

“12-channel electrocardiograph used to record and analyze cardiac electrical signals, model…, voltage…, power…, brand…, manufacturer…, 100% new.”

For equipment with an integrated printer:

“12-channel electrocardiograph with integrated display and thermal printer, used to record, display and analyze cardiac electrical signals, model…, brand…, manufacturer…, 100% new.”

A vague description such as:

“Heart measuring machine”

should be avoided because it does not adequately describe the device’s principal function.

Step 8: Submit Documents and Cooperate with Customs Inspection

Customs may request additional documents such as:

  • Product catalog
  • Datasheet
  • User manual
  • Product photographs
  • Label photographs
  • Functional diagrams
  • Channel and lead specifications
  • Medical device classification documentation
  • Circulation documentation

Step 9: Pay Taxes and Complete Customs Clearance

After fulfilling tax obligations and applicable medical device 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 should be applied if the original label does not contain all mandatory information in Vietnamese.

6. Important Notes When Importing ECG Machines

Importers should pay attention to the following:

  • Do not confuse an ECG machine with a patient monitor
  • Do not confuse an ECG machine with a basic heart-rate monitor
  • Distinguish a standard ECG machine from a Holter ECG recorder
  • Verify the exact number of channels
  • Verify the number of leads
  • Check automatic ECG interpretation capability
  • Check the integrated printer
  • Check internal memory
  • Review LAN, USB, Wi-Fi, or other communication interfaces
  • Check connectivity with HIS, EMR, or other hospital systems where applicable
  • Check the integrated battery
  • Review electrical safety standards
  • Do not use regulatory documents issued for a different model
  • Review accessories imported separately

Common accessories may include:

  • Patient cable
  • ECG lead wires
  • Limb electrodes
  • Chest electrodes
  • Disposable ECG electrodes
  • ECG recording paper
  • Battery
  • Power adapter
  • Power cord
  • Equipment trolley
  • Communication module
  • ECG software

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

Labeling Requirements

The product label should generally include:

  • Product name
  • Brand
  • Model
  • Serial number
  • Manufacturer
  • Manufacturer’s address
  • Country of origin
  • Voltage
  • Frequency
  • Power capacity
  • Battery type, where applicable
  • Main technical specifications
  • Safety warnings
  • Storage conditions

The Vietnamese supplementary label should also contain the name and address of the organization responsible for the product in Vietnam, intended use, instructions, safety warnings, and other mandatory information not already provided in Vietnamese.

Used ECG Machines

For used ECG machines, importers should separately review:

  • Year of manufacture
  • Equipment age
  • Serial number
  • Manufacturing standards
  • Hardware condition
  • ECG amplifier condition
  • Signal accuracy
  • Printer condition
  • Battery condition
  • Maintenance records
  • Calibration records
  • Inspection certificates
  • Import conditions applicable to used medical equipment

Used ECG equipment should not be shipped to Vietnam until the importer has confirmed its legal import eligibility and technical condition.

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7. ECG Machine Import Services

A customs and logistics service provider may support importers with:

  • Import policy review
  • Medical device classification review
  • 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 catalog review
  • Technical document review
  • Product label review
  • Preparation of customs documentation
  • Customs declaration
  • Coordination of physical inspection
  • Customs clearance
  • Delivery to the importer’s warehouse

Reviewing the medical device documentation, product model, and HS classification before shipment can reduce the risk of goods arriving in Vietnam before all regulatory requirements have been completed.

8. FAQ – Frequently Asked Questions

8.1 Is an ECG Machine Considered a Medical Device?

Yes. An ECG machine is designed to record and analyze the electrical activity of the heart and is regulated as a medical device.

8.2 Is an Import License Required for an ECG Machine?

The answer should not be determined from the product name alone. The importer should review the device classification, applicable circulation documentation, intended use, and regulatory requirements for the specific model.

8.3 What Is the HS Code for an ECG Machine?

Electrocardiographs are generally considered under subheading:

  • 9018.11

The complete HS code should be determined according to the Vietnamese tariff schedule and the actual configuration of the device.

8.4 Does a Holter ECG Recorder Use the Same HS Code as a Standard ECG Machine?

Not necessarily. A Holter recorder is designed to record ECG signals continuously over an extended period and may have a different construction and operating configuration from a standard desktop ECG machine.

Its HS classification should therefore be reviewed separately.

8.5 Do 3-Channel and 12-Channel ECG Machines Have the Same HS Code?

The number of channels is not the only factor determining HS classification.

Where both products have the principal function of electrocardiography, they may fall within the same relevant subheading. However, the specific configuration of each model should still be reviewed.

8.6 Is a Product Catalog Required?

Yes. A product catalog is important for verifying:

  • Principal function
  • Number of channels
  • Number of leads
  • Operating principle
  • Analysis capabilities
  • Equipment configuration
  • HS classification

8.7 Can ECG Accessories Be Imported Separately?

Yes. However, ECG cables, electrodes, batteries, recording paper, trolleys, and communication modules imported separately should be reviewed for their own HS classification and import requirements.

They should not automatically use the HS code of the complete ECG machine.

9. Conclusion

An ECG machine is a medical device used to record and analyze the electrical activity of the heart. Before importing, businesses should review the medical device classification, circulation documentation, product model, manufacturer, HS code, tax obligations, and labeling requirements.

For electrocardiographs, subheading 9018.11 may be used as a reference starting point. However, the complete HS code must be determined based on the principal function, number of channels, number of leads, recording and analysis capability, equipment configuration, product catalog, and technical documents of each specific model.

Reviewing the regulatory documents and technical specifications before shipment can help prevent incorrect HS classification, missing medical device documentation, 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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Address: No. 5, Dong Da, Tan Son Hoa Ward, Ho Chi Minh City.

Hotline: +84 83 9910066

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