ImportMedical devicesHas become a key means for hospitals and medical institutions to improve diagnosis and treatment levels. However, the import process for medical devices is complex, involving multiple procedures and strict regulatory requirements. How to smoothly import medical devices has become a focus for many enterprises. This article will take the import of medical devices (endovenous radiofrequency closure generator) as an example to detail its import process and required documentation at Shanghai Airport, hoping to provide reference and guidance for relevant enterprises.

Customer Background: A medical device company entrustedZhong Shen International Tradean agent to import an endovenous radiofrequency closure generator (ClosureRFC) for clinical treatment in hospitals.

Cargo Information:

• Transportation method: Airair freighttransport
• Storage Location: Pudong Airport
• Customs Declaration Mode: General Trade (0110)
• Duty Collection Type: General Taxation (101)
• Port of Entry: Shanghai Pudong International Airport
• Type of Packing: Paper or fiberboard boxes/cases
• Number of Packages: 1
• Gross Weight/Net Weight: 9.2 kg/8 kg
• Transaction Method: FOB (Free On Board)
• Accompanying Documents: Countermeasure exclusion code P
• Commodity Code: 9018909919
• Product Name: Intracavitary Radiofrequency Closure Generator ClosureRFC
• Quantity and Unit: 1 unit
• Country/Region of Origin: United States (USA)
• Final destination country/region: China (CHN)
• Port of Operation: Shanghai Airport

01 Required Documents for Medical Device Imports

1. Trade contract, commercial invoice, packing list: These are basic trade documents used to confirm transaction details, including both parties, product description, quantity, price, etc.
2. B/L: This serves as proof of ownership for the goods and is a crucial document for cargo pickup.
3. Medical Device Import Registration Certificate: This is the key certificate for importing medical devices, proving the device has been registered and approved by domestic authorities, meeting import requirements.
4. Importer Qualifications: Includes business license, medical device operation license, etc., to demonstrate the companys legal eligibility for importing medical devices.
5. Other documents required by customs: Additional documents such as quality inspection reports and product manuals may be required depending on specific circumstances.

02 Import Duties for Medical Devices

Import duties and VAT are mandatory taxes for medical device imports. Specific rates are determined by the products HS code:

• Most - Favored - Nation (MFN) Tariff Rate: Determined by specific HS code, typically ranging between 0-5% for medical devices.
• Value - added tax rate: 13%
• Remarks: There are numerous categories, with different HS codes corresponding to different import tax rates. Commodity classification must be completed prior to import.

03 Medical Device Import Process

Pre-shipment Preparation:

1. Organize required documents: Ensure all documents are complete and accurate.
2. Verify product documentation: Confirm all document information matches the actual goods.

After Goods Arrival at Port:

1. Obtain delivery order: Exchange for delivery order with the airline or its agent.
2. Customs Declaration and Inspection: Submit customs declaration and inspection documents to customs and quarantine authorities.
3. Tax review and payment: Customs reviews taxes and issues tax notice. Enterprise pays duties and VAT according to tax notice.
4. Inspection (random): Customs may conduct random inspections to verify compliance with declared contents.
5. Release: After customs inspection is cleared, goods are released.
6. Deliver goods to customers designated warehouse: Arrange logistics to transport the goods to the customers specified location.
7. Destination inspection (random): Random inspections are conducted at the destination to ensure the goods comply with relevant regulations.

04 Key Considerations for Medical Device Imports

1. Prohibition on Used Mechanical and Electrical Products: Used medical devices are generally prohibited from import unless special permits are obtained.
2. Import Supervision Requirements: Used mechanical and electrical products listed in the Inspection and Supervision Measures List for Imported Used Mechanical and Electrical Products require special national permits. The consignee must submit a statement to the inspection and quarantine authority at the port of entry assuming responsibility for quality and safety issues during product use.

To better understand the above process, the following provides a detailed breakdown of the entire import procedure using practical examples.

Document Organization and Information Verification

Before the shipment of goods, the customer provided documents including the trade contract, commercial invoice, packing list, and import medical device registration certificate. ZhongShen International Trades team carefully verified all document information to ensure its accuracy.

Operations after goods arrive at port

After the goods arrived at Shanghai Pudong International Airport, ZhongShen International Trades team immediately began the process of exchanging the delivery order, customs declaration, and inspection. Due to thorough preparation, the customs declaration and inspection processes proceeded smoothly.

Tax payment and customs inspection

After customs review, a tax bill was issued, and ZhongShen International Trade paid the tariff and VAT on behalf of the client. Subsequently, customs conducted a random inspection of the goods, and after confirming the goods matched the declared contents, they were released.

Goods pickup and delivery

After the goods were released, ZhongShen International Trade arranged logistics to transport the goods to the clients designated warehouse. After random sampling at the destination confirmed the goods were correct, they were successfully delivered to the client.

The import process for medical devices is complex and stringent, requiring careful handling at every stage to ensure compliance with relevant regulations. With its professional team and extensive experience, ZhongShen International Trade can provide clients with efficient and professional import and delivery services, ensuring the smooth import of every batch of goods. If you require agency services for importing medical device products, feel free to consult us online. We are committed to providing you with the highest quality service.