Global Healthcareequipment. 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.Policy landscape evolution

In 2025, major global medical device markets show stricter regulatory trends. China Customs Announcement No. 63 shortensMedical Equipmentagency authorization periods for Class II devices to 14 months. The EUs new MDR certification introduces dynamic traceability mechanisms, while the US FDA strengthens UDI (Unique Device Identification) system application. According to IMDRF data, compliant agency services can reduce customs clearance time by 40% and lower administrative penalty risks by 25%.

Core steps for medical device agency authorization

• Qualification verification stage
  • Verification of manufacturers ISO 13485 system certification validity
  • Confirmation of target market access certificate timeliness (e.g. CE/FDA/CMDCAS)
• Legal document preparation
  • Dual requirements for notarization and authentication of power of attorney
  • Professional verification of product technical document translation
• Customs clearance practical operations
  • Dual verification mechanism for HS code classification accuracy
  • Compliance review of special packaging requirements

Regional regulatory differences comparison (2025 edition)

Typical risk mitigation solutions

A case study of importing German CT equipment shows that the agency successfully reclassified the equipment originally under HS code 9022.14 to 9018.90, resulting in a tariff difference of 7.2%. Practical recommendations include:Pre - classification dispute resolution mechanismEstablishing a dynamic regulatory monitoring system (monthly update frequency)

• Implementing dual-track document management (paper + blockchain notarization)
• Conducting pre-clearance simulation audits
• Dedicated medical device service team (recommended 5+ years industry experience)

Key indicators for agency service selection

Qualified agency companies should possess:

• Emergency response network at major ports (4-hour on-site commitment)
• Customs AEO Advanced Certification qualification
• Successfully handled ≥20 cases of Class II medical device filing modifications
• The medical equipment import sector in 2025 shows a trend of regulatory-technological integration. The pilot application by China Customs

can improve commodity classification accuracy to 98.7%. Importers should pay special attention toIntelligent Classification Assistance Systemquality traceability clausesin authorization documents to avoid clearance delays caused by unclear supply chain responsibility allocation.Three core elements of medical equipment import agency authorization in 2025