Importing Medical Devices from China: US and EU Duty Rates and Regulatory Checklist

Over my 20 years sourcing from China, I've watched medical equipment imports grow from simple disposables to sophisticated diagnostic devices. China is now the world's second-largest medical equipment market, and while quality has improved dramatically, many importers still overlook the critical details—like customs duties and certification. If you're considering sourcing from China, understanding both the duty rates and compliance requirements can save you thousands and prevent costly delays.

Medical equipment from China

Sourcing medical equipment from China do not have to be complicated. Most importers stick to not complicated, basic medical utilities, such as disposable syringes, urine bags, or stethoscopes. More sophisticated equipment goes in the other direction. Hundreds of major foreign companies sell their products in China, and most of those are sourced from manufacturers in major cities such as Beijing or Shanghai.

China’s medical device industry is heavily fragmented but provides a satisfactory level of research and development driven by governmental investment. Foreign companies, such as GE Healthcare, Philips, and Siemens, have their representative offices on Chinese soil. Domestic manufacturers tend to export their products to developing markets.

What kind of products can be interesting from the perspective of a Western buyer? We need to emphasize that the quality inspection system is getting better, so we should not restrict ourselves only to laboratory equipment and disposable medical supplies. If the product has a proper CE marking, it is allowed for sale in the EU.

Below we present duty rates for several categories of medical equipment:

EU duty rate for medical equipment

• Computed tomography apparatus for medical, surgical or veterinary uses (90221400) – 0%
• Photographic film in rolls for X-ray (37021000) – 6.5%
• Medical or surgical sterilizers (84192000) – 0%
• Ultrasonic scanning apparatus (90181200) – 0%
• Surgical gloves (40151200) – 2%
• Monitoring apparatus for simultaneous monitoring of two or more parameters (90181910) – 0%
• Artificial teeth (90212190) – 0%
• Syringe (90183190) – 0%
• Insulin medicaments (30033100) – 0%
• Mask (6307909810) – 0%

US duty rate for medical equipment

• Computed tomography apparatus (9022.12.00) – 0% + 25%
• Photographic film in rolls for X-ray (3702.10.00) – 3.7% + 25%
• Medical or surgical sterilizers (8419.20.00.10) – 0%
• Ultrasonic scanning apparatus (9018.12.00.00) – 0% + 25%
• Surgical gloves (4015.12.10.20) – 0% + 7.5%
• Basal metabolism and blood pressure apparatus (9018.19.95.30) – 0% + 25%
• Artificial teeth (9021.21.80.00) – 0%
• Syringe (9018.31.00.80) – 0%
• Insulin medicaments (3003.31.00.00) – 0%
• Face mask (4818.90.00.20) – 0% + 25%

In the case of many products, CE marking is required. Procedures for proper classification of the device are described here. Usually, every medical device may be classified as Class I (including Is & Im), Class IIa, IIb, and III, with Class III covering the highest-risk products. The higher the classification, the greater the level of assessment required. It is worth noting that separate regulations are related to in-vitro diagnostic devices. Those are divided into “List A” and “List B” and require production quality assurance. A detailed description is provided here.

Navigating customs duties and CE marking is just the first step—ensuring your supplier delivers compliant, high-quality products is the real challenge. Before placing a large order, invest in third-party factory inspections and quality control. At China-Check, we help U.S. buyers verify suppliers, audit production, and test samples so you can source with confidence. Don't leave your medical equipment supply chain to chance.