The general agency model in healthcareEquipment ImportsThe strategic value in

Germany in 2025Medical EquipmentExport data shows that the proportion of medical equipment imports through authorized general agent channels has reached 67%, achieving a 14% reduction in overall costs compared to the distribution model. Selecting qualifiedIVD certificationAs the general agent partner, you can obtain three core advantages:

• Directly interfacing with the original manufacturer's technical team, the equipment debugging response speed has increased by 40%.
• Enjoy the unified after-sales service standards within the EU region, with the warranty period extended to 36 months.
• Secure exclusive supply sources to avoid disputes over equipment serial numbers caused by parallel imports.

Analysis of Key Import Processes in Germany for 2025

According to the latest revised EU Medical Device Regulation (MDR 2025), the following core steps must be completed for the import of medical devices:

• Qualification verification stage
  • Please verify whether the general agent's CE certification includes the upgrade clause for MDD 93/42/EEC.
  • Confirm that the equipment complies with the ISO 13485:2025 quality management system requirements.
• Logistics customs clearance process
  • Medical linear accelerators and other Class IIb equipment require separate application for radiation safety certification.
  • Utilizing the ATA Carnet temporary admission clause can save 27% of the deposit.

Key Points of Customs Compliance Operations

For the particularities of German GE medical equipment, special attention should be paid to customs declarations in 2025:

• The main unit of the CT equipment and the contrast agent injection system should be declared separately (difference between HS codes 9018.19 and 9018.90).
• Equipment containing radioactive components must provide the BfS nuclear safety filing certificate.
• Precision instruments require transportation in a constant temperature and humidity container with temperature fluctuations ≤±1.5℃.

Professional agency service screening criteria

Chooseforeign tradeWhen selecting an agency service provider, key considerations should include:

• Does the company have a dedicated customs clearance team for medical devices (it is recommended to request a review of import cases from the past three years)?
• Emergency response capabilities at major ports such as Hamburg and Bremerhaven.
• Practical experience with Germany's VAT deferral mechanism (can reduce capital occupation by 16%)

Practical Case: Optimization of 3.0T MRI Equipment Import

A top-tier hospital achieved the following through professional agency services:

• The originally required 8-week health quarantine process has been shortened to 19 working days.
• By utilizing tariff guarantee insurance as a substitute for cash deposits, 3.2 million yuan in working capital was released.
• Through transportation route optimization, the equipment vibration coefficient is controlled below 0.5g.

Forecast of Market Trends in Germany for 2025

Based on the latest trends at the Berlin Medical Exhibition, it is recommended to focus on:

• The import of second-hand medical equipment requires an additional TUV inspection report (effective March 2025).
• The competition between Siemens Healthineers and GE in modular equipment has intensified, with the bargaining space expanding by 12-15%.
• German Customs Implements AI Inspection System, Raising Document Accuracy Requirement to 99.2%