During the process of exporting medical products to Spain, enterprises must fully understand and comply with local import regulations and requirements to avoid any delays or returns of goods during customs clearance. Spain is particularly strict about the import of medical products, requiring not only general commercial invoices and transportation documents but also necessary permits and registration certificates. This article will provide a comprehensive export guide, from customs clearance documents to specific certifications, from practical suggestions to risk control, to ensure that products can smoothly enter the Spanish market.

Basic documents:

Commercial Invoice:List detailed information about the goods, including the shipper, consignee, description of the goods, quantity, price, etc.
Packing List:Specify in detail the description, quantity, and weight of each item in the package.
Transport document (such as bill of lading orAir Transportationwaybill):Prove the mode of transport and route of the goods.

Special requirements:

Import license:For medical devices and certain specific medical supplies, Spain requires importers to hold the corresponding import license.
EU EPR registration code:According to Royal Decree No. 993/2022 of Spain on November 29, 2022, all medical products must be registered in the Environmental Protection Recycling System (EPR), and the EPR registration code must be indicated in the customs clearance documents. Unregistered products will not be able to clear customs in Spain.
Quality compliance certificate (CQ, Certificate of Quality):Indicate that the product has passed quality inspection and meets the standards of the exporting and importing countries.

CE mark
All medical devices entering the EU market must meet CE standards, indicating that the product meets the EUs safety, health, and environmental protection requirements.
AEMPS Registration
For medical products, especiallyMedical Equipmentmedicines, the Spanish Agency for Medicines and Health Products (AEMPS) requires all related products to be registered with this agency. Relevant information and requirements can be found on the official website of AEMPS.

Clarify customer needs and regulatory requirements
Before accepting an order, clarify all specific needs and compliance requirements with the customer to ensure compliance with all regulations during the transaction process.
Prepare sufficient documents and certificates
Ensure that all required documents and certificates are complete and accurate, especially the import license and EPR registration code, to avoid delays or returns of goods at customs.
Use professional logistics and customs clearance agents
It is recommended to use logistics and customs clearance agents who are familiar with the import regulations of medical products in the EU, especially in Spain. They can provide professional advice and services to help with smooth customs clearance.
Understand and respond to potential risks
Understand possible risks such as customs clearance delays, additional costs, or product returns, and prepare corresponding countermeasures.

In conclusion, exporting medical products to Spain not only requires compliance with general import regulations but also special attention to the specific registration and certification requirements of medical products. Adequate preparation and reasonable risk management are the keys to ensuring a smooth transaction. Through the detailed guidance in this article, every step of the operation can be accurate, and every document can be prepared completely, thus avoiding unnecessary delays or return risks.