In recent years, China's medical device industry has developed rapidly and its position in the global market has become increasingly prominent. As the world's largest medical device market, the United States has always been China'sMedical DevicesThis article will analyze in detail the current status of China's medical equipment exports to the United States, the specific export process and other matters needing attention.

Current status of exports

Export quantity

According to statistics from the China Chamber of Commerce for Import and Export of Medicines and Health Products, in the first three quarters of 2024, China's import and export of medical devices was US$62.19 billion, a year-on-year increase of 0.1%. Among them, the export value was US$35.34 billion, a year-on-year increase of 4.4%. The United States is still China's largest exporter of medical devices. In the first three quarters of 2024, China's exports of medical devices to the United States increased by 7.3% year-on-year, showing a good growth trend.

Export categories

From the point of view of the types of exported products, it covers a wide range, and some categories have grown significantly.

In the field of disposable consumables, the export volume in the first three quarters of 2024 was US$7.6 billion, a year-on-year increase of 10.64%. Among them, the export of gloves has recovered across the board, with a significant increase. Syringes and other products also occupy a certain share in the US market. In terms of rehabilitation assistive devices, Chinese products are also very popular. In 2023, the scale of rehabilitation medical equipment exports to the United States reached 10 billion yuan. Wheelchairs, walkers and other products meet the needs of the aging American society for rehabilitation care.

In diagnostic and therapeutic equipment, In the first three quarters of 2024, the export value of hospital diagnostic and therapeutic products amounted to 16.013 billion U.S. dollars, a year-on-year increase of 3.2%. Enough to see China's technological progress and innovation in the field of high-end medical equipment.

Dental equipment and materials, Exports in the first three quarters of 2024 amounted to USD 1,553 million, a year-on-year increase of 7.12%. Products like comprehensive dental treatment tables and oral implants are gradually gaining recognition in the US market. Medical dressings exports amounted to $2.935 billion, down year-on-year, but in the first three quarters of 2024, China's exports of dressings to the United States increased by more than double-digit year-on-year, high-end dressings and other segments of the export growth rate of the United States is significant.

II. Export Process

Product Preparation

1. Clarify regulations and standards：The U.S. Food and Drug Administration (FDA) has strict supervision over medical devices. Before exporting, companies must thoroughly understand the relevant FDA regulations and other U.S. domestic standards. Different types of medical devices have very different regulatory requirements. For example, Class I medical devices are low-risk and usually only require simple registration; while Class III medical devices are higher-risk and may require comprehensive pre-market approval (PMA), involving a large amount of clinical data and strict technical evaluation.
2. Complete registration and licensing：Most medical devices need to be registered with the FDA, and some products also need to obtain 510 (k) pre-market notification or PMA licenses. Companies need to prepare detailed application materials, including product design, performance indicators, quality control processes, clinical evaluation data, etc., to prove the safety and effectiveness of the product.
3. Strict quality control：Passing ISO 13485 medical device quality management system certification is a basic requirement. During the production process, the procurement of raw materials, production processes, and finished product inspections must be strictly monitored to ensure that the products meet US and international quality standards. Each batch of products should have complete quality inspection records, including raw material inspection reports, key process inspection records during production, and finished product final inspection reports, etc., for traceability and inquiry.

Transportation Arrangements

1. Choose your shipping method: Ocean freight has lower costs and is suitable for large-volume, non-urgent medical equipment transportation. However, the transportation cycle is longer, and it takes about 15-40 days from a Chinese port to a US port, depending on the port of departure and the port of destination. Air freight is fast and can meet the needs of urgent orders. It usually takes 1-3 days to reach the United States, but the cost is relatively high. Companies need to make comprehensive considerations based on factors such as product characteristics, delivery time, and cost budget.
2. Choosing a logistics partner: Prioritize logistics companies that have extensive experience in medical device transportation and are familiar with FDA regulations and U.S. customs clearance procedures. These professional logistics companies can provide one-stop services, including door-to-door pickup, booking, customs declaration, transportation insurance, customs clearance at the destination port, and distribution, to ensure the safety and timely delivery of goods.

US Customs Clearance

1. Prepare customs clearance documents
   • Commercial invoice: describes in detail the name, specifications, quantity, unit price, total price and other information of the goods
   • Packing list: clearly specify the items, quantity, weight and volume in each package
   • Certificate of Origin: Proof of the origin of the goods
   • FDA registration certificate: used to show that the product has passed FDA review
   • Quality certificate: issued by a qualified third-party testing agency to prove that the product meets relevant quality standards
   • In addition, if the product requires 510 (k) or PMA documents, they should also be prepared. If necessary, other documents such as health certificates and import permits may also be required.
2. Accurately declare value：The declared value should reflect the true value of the goods. Over-declaration or under-declaration may cause customs to question. Over-declaration may cause importers to pay additional duties and taxes, increasing costs; under-declaration may be considered by customs as an attempt to evade duties, facing the risk of fines or even goods being seized. Customs will assess the declared value based on market conditions, prices of similar products and other factors.
3. Cooperate with customs inspection：The U.S. Customs has the right to inspect imported goods, and companies should actively cooperate. Before the goods arrive at the U.S. port, communicate with the freight forwarder or customs broker in advance to ensure that the cargo information is accurate. If the customs requires unpacking for inspection, relevant assistance should be provided in a timely manner, such as arranging personnel to cooperate with the customs inspection at the designated time and place, and providing detailed information and explanations of the product. If problems are found during the inspection, they should be rectified in a timely manner to ensure smooth customs clearance of the goods.

III. Laws and Regulations

1. Registration and Listing: All medical devices sold or distributed in the United States must be registered and included in the FDA's medical device list. Detailed information about the product must be provided during registration.
2. Quality Standards: Medical devices must comply with relevant standards and regulations established by the US FDA, including requirements on quality management system, product performance, safety and effectiveness.
3. Reporting and Records: Medical device manufacturers are required to submit regular reports and records in accordance with FDA regulations, including product adverse event reports, corrective and preventive measures, product quality issues, etc.

IV. Certification Standards

1. FDA 510(k) premarket notification clearance: Some Class I, Class III, and most Class II medical devices require FDA 510(k) premarket notification approval to prove that the product is substantially equivalent to a similar product that has been legally marketed.
2. FDA PMA (Premarket Approval): Most Class III and some Class II medical devices require FDA PMA, which involves more detailed technical and clinical evaluations.

V. Packaging labeling requirements

1. Package: Packaging materials must have good cushioning, moisture-proof, and dust-proof properties to prevent the equipment from being physically damaged or damaged by moisture during transportation. At the same time, the packaging should be easy to carry and store, and clearly marked with information such as the product's weight, volume, and handling precautions.
2. Logo: The text content must be clearly labeled with the product name, model number, manufacturer's name, address, contact information and other basic information. Instructions for use should be detailed and easy to understand, including the operating procedures of the equipment, scope of application, contraindications, maintenance methods and so on. In addition, the possible risks need to be significantly labeled.
3. Graphic Logo: Adopt international standard graphics, and clear, eye-catching, printed in the prominent position of the package, easy to identify people with different language backgrounds.
4. UDI：Since the US FDA issued the Unique Device Identification (UDI) system regulations in September 2013, all medical devices entering the US market must be marked with the unique device identification code UDI on their labels and packaging and registered in the GUDID public database. Through UDI coding, the entire life cycle of medical devices from production, circulation to use can be traced.

Conclusion

Driven by technological innovation, Chinese medical equipment will become more intelligent and personalized to meet the increasingly diverse needs of the US market. However, companies must also be aware that the US market is strictly regulated, competitive, and various uncertainties still exist. Companies must continue to pay attention to changes in regulations and policies, strengthen technological innovation, improve product quality and service levels, and actively respond to challenges in order to move forward steadily in the fiercely competitive US market.