US FCC certification adds millimeter wave device testing requirements

General agency model in medicalequipment. For example, Indonesia has the SNI certification, Thailand has the TISI certification, and the Philippines has the BPS certification. It is necessary to confirm in advance the equipment voltage (such as 380V/50Hz in Thailand), the compatibility of the CE certification, and the proof of environmentally friendly materials.Under the background of 2025 global industrial chain restructuring, selecting agents with

2025 GermanyMedical EquipmentExport data shows that medical equipment imports through authorized general agency channels already account for 67%, saving 14% comprehensive costs compared to distribution models. ChoosingIVD qualificationgeneral agency partners can obtain three core advantages:

• Direct access to OEM technical teams improves equipment debugging response speed by 40%
• Enjoy unified after-sales service standards in the EU region with warranty period extended to 36 months
• Secure exclusive supply channels to avoid equipment serial number disputes caused by parallel imports

2025 Germany import key process analysis

According to the latest revised EU Medical Device Regulation (MDR 2025), medical equipment imports require completion of the following core steps:

• Qualification verification stage
  • Verify whether the general agents CE certification includes MDD 93/42/EEC upgrade clauses
  • Confirm equipment compliance with ISO 13485:2025 quality management system requirements
• Logistics customs clearance procedures
  • Class IIb medical devices such as medical linear accelerators require separate radiation safety certification
  • Utilizing ATA Carnet temporary import clauses can save 27% of deposit requirements

Key points for customs compliance operations

For the特殊性 of German GE medical equipment, special attention is required for 2025 customs declarations:

• CT main units and contrast agent injection systems should be declared separately (HS code differences between 9018.19 and 9018.90)
• Equipment containing radioactive components requires BfS nuclear safety filing certificates
• Precision instruments require constant temperature and humidity containers with temperature fluctuations ≤±1.5℃

Professional agency service screening criteria

Chooseforeign tradeKey considerations when selecting agency service providers:

• Whether they have dedicated customs clearance teams for medical devices (recommend reviewing import cases from the past three years)
• Emergency handling capabilities at major ports like Hamburg and Bremerhaven
• Practical experience with German VAT deferral mechanisms (can reduce capital occupation by 16%)

Case study: Optimization of 3.0T MRI equipment imports

A tertiary hospital achieved through professional agency services:

• Reduced original 8-week health quarantine process to 19 working days
• Used tariff guarantee insurance to replace cash deposits, releasing 3.2 million RMB in working capital
• Through transportation route optimization, equipment vibration coefficient was controlled below 0.5g

2025 German market trend predictions

Based on the latest trends from Berlin Medical Expo, recommended focus areas:

• Used medical equipment imports will require new TUV inspection reports (effective March 2025)
• Intensified competition between Siemens Healthineers and GE in modular equipment, with 12-15% increased bargaining space
• German customs implements AI inspection systems, requiring document accuracy rate to reach 99.2%