HS Code:
Electrocardiographs (ECGs), classified under HS Code 9018.11, are medical devices used to record the electrical activity of the heart over a period of time. They are critical diagnostic tools in cardiology for detecting heart conditions such as arrhythmias, ischemia, and other cardiovascular diseases. This category also includes parts and accessories thereof, such as electrodes, cables, and software used in conjunction with ECG machines. These products are integral to healthcare systems worldwide, with demand driven by aging populations, rising cardiovascular diseases, and advancements in telemedicine and portable diagnostic technologies.
Total Trade Volume
USD 1.2 billion
Data from 2022
Source
United Nations Comtrade Database
USD 350 million
29.2% of total trade of total trade
Increasing
USD 200 million
16.7% of total trade of total trade
Stable
USD 150 million
12.5% of total trade of total trade
Increasing
USD 100 million
8.3% of total trade of total trade
Increasing
USD 80 million
6.7% of total trade of total trade
Stable
Average Rate
4.5% ad valorem
Highest Rate
12% (applied by certain developing countries)
Lowest Rate
0% (under free trade agreements like EU-US agreements or WTO commitments)
Rising demand for portable and wearable ECG devices
Increased market share for compact, user-friendly devices due to telemedicine growth and home healthcare trends
2021-2023
Integration of AI and cloud-based diagnostics
Enhanced accuracy and remote monitoring capabilities driving adoption in hospitals and clinics
2022-2023
Supply chain diversification
Manufacturers shifting production to multiple regions to mitigate risks from geopolitical tensions and pandemics
2020-2022
The US Food and Drug Administration approved a new wearable ECG patch that offers continuous monitoring for up to 14 days, developed by a leading medical technology company.
March 2023
Expected to boost exports of wearable ECG devices from the US and increase competition in the global market.
The European Union introduced updated Medical Device Regulations (MDR) requiring more rigorous clinical evaluations for ECG devices entering the market.
May 2021 (fully enforced in 2023)
Potential delays in market entry for non-compliant manufacturers, increasing costs for compliance but ensuring higher safety standards.
China announced incentives for local manufacturers to produce affordable ECG machines, aiming to reduce reliance on imports and capture a larger share of the domestic market.
January 2023
Likely to increase China's export volumes in the low-cost segment while challenging established exporters in price-sensitive markets.