HS Code for ECG Machines
The HS Code for ecg machines is 901811. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 901811 |
|---|---|
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 90 |
| Heading | 9018 |
| Last Updated | 2026-05 |
Description
Electrocardiographs
HS Code 901811 covers electrocardiographs (ECG machines) with a US MFN duty rate of Free.
Frequently Asked Questions
Does importing an ECG machine (HTS 901811) into Brazil require ANVISA pre-market approval or registration?
Yes, ECG machines are classified as Class II medical devices by Brazil's National Health Surveillance Agency (ANVISA) and require a Cadastro registration prior to importation. The importer of record must be a Brazilian company legally established with ANVISA and provide the device's technical dossier, labeling, and proof of conformity with applicable standards.
How does the presence of additional diagnostic software or analysis algorithms affect the classification of an ECG machine under HTS 901811?
The addition of diagnostic software or algorithms that provide automated interpretation does not change the classification; HTS 901811 specifically covers electrocardiographs, which are defined by their function of recording cardiac electrical activity. However, if the software transforms the machine into a multi-function diagnostic system that performs analyses beyond simple ECG recording (e.g., detailed hemodynamic calculations), it may be classified elsewhere, such as under 9018.19 or 9018.90.
Alternative & Confusing Classifications for ECG Machines
ECG machines are primarily classified under 9018.11, but can be misclassified under 9018.19 for 'Other electro-diagnostic apparatus' if they lack a direct recording feature. Portable/holter monitors are distinct and typically fall under 9018.19. More broadly, multi-parameter patient monitoring systems that include ECG functionality are classified separately under 9018.19.09 or 9018.19.95, as they are not dedicated ECG devices. Always verify the primary function and recording capability to ensure correct classification.
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