How to choose qualified medical consumablesExport agentThe company?

Choosing an agency should focus on the following factors:

• Industry-specific qualifications:Medical DevicesBusiness license, ISO13485 certification
• Overseas certification experience: Capability to handle target market access qualifications like FDA/CE/MDR
• Special logistics capabilities: Professional solutions including cold chain equipment, biosafety packaging
• Compliance Records: No major customs penalties or quality incidents in past 3 years

What new certifications are required for medical consumables export in 2025?

According to latest 2025 policy requirements:

• EU MDR certification transition period ends, all Class IIa+ products must complete new regulation registration
• US FDA expands mandatory UDI traceability system coverage
• ASEAN launches Medical Device Common Submission Framework (ACMF)
• Recommend confirming target market latest access lists with agency companies

How to optimize medical consumables export logistics solutions?

Professional agency companies should provide customized solutions:

• Temperature - controlled transportation: Select 2-8°C or -20°C cold chain solutions based on product characteristics
• Packaging validation: International standard vibration/drop tests like ISTA 3E
• Customs clearance acceleration:
  • Pre-review medical device HS code classification
  • Prepare complete quality traceability documents
• Emergency response mechanism: Establish regional emergency warehousing network

Different countriesThe CustomsHow to handle policy differences?

2025 key market tariff characteristics:

• USA: The 301 tariff exemption list is dynamically adjusted, and it is recommended to adopt the "first sale" rule.
• The European Union: Carbon Border Adjustment Mechanism (CBAM) pilot covers medical plastic products
• Southeast Asia: RCEP agreement provides 8-12% tariff reduction for medical consumables
• Professional agency companies should provide tariff pre-classification + preferential COO certificate application services

How to control legal risks in medical consumables export?

Must establish three-level risk control system:

• Contract Terms: Clearly define quality responsibility division and product liability insurance terms
• 11. Intellectual property: Conduct overseas patent search and design-around in advance
• Compliance review:
  • Export control item screening (ECCN codes)
  • Sanctioned entities list comparison
• Recommend agency companies provide professional review of force majeure clauses

How to guarantee after-sales service for medical consumables export?

Professional agencies should possess following service capabilities:

• Rapid response mechanism: Complete overseas return shipment declaration within 48 hours
• Technical documentation support: Provide multilingual user manuals and after-sales record templates
• Quality Traceability System: UDI code traceability throughout logistics information
• Early Warning Services: Real-time push of overseas market quality inspection information

How to respond to emerging market access policy changes?

Key concerns in 2025:

• Brazil ANVISA implements Unique Medical Device Identification (UMI) system
• Saudi SFDA updates technical regulations for personal protective equipment
• Indonesia BPJPH strengthens halal certification requirements
• Recommend choosing an agency company with local branches

How to evaluate agency companies professional service capabilities?

It is recommended to adopt the "Four-Dimensional Evaluation Method":

• Case verification: Require successful export cases of similar products
• System demonstration: Check data interface capability between their customs clearance system and overseas regulators
• Resource inspection: Verify qualifications of their overseas customs clearance partners
• Emergency testing: Simulate response plans for sudden policy changes