Is it necessary to find a professional agent for medical device exports?

The core value of professional agents lies in reducing compliance risks.According to 2022 statistics from China Customs, 68% of medical device export return cases involved missing qualification documents or non-compliance with technical standards. Qualified agencies should possess:

• Class III medical device operation filing certificate
• ISO 13485 quality management system certification
• Target country customs clearance case database
• Medical device registration agency service qualification

What are the differences in medical device certifications across different countries?

Since the EU implemented the new Medical Device Regulation (MDR) in 2020, certification requirements in major global markets have continued to upgrade:

• EU CE certificationRequires review by a Notified Body, including clinical evaluation reports
• US FDA registration510(k)/PMA classification management, UDI traceability system implementation starting from 2025
• Japan PMDA certificationMust designate a domestic Marketing Authorization Holder (MAH)
• Southeast Asian MarketsMalaysia MDA, Thailand TFDA and others require local authorized representatives

How to avoid delays in medical device export customs clearance?

Based on our experience handling 500+ medical device export cases, we recommend focusing on:

• Pre - classification of goodsAccurate matching of HS codes with regulatory documents
  • Surgical instruments fall under 9018.9090
  • Diagnostic equipment falls under 9027.8090
• Document completeness:
  • Certificate of Origin + Quality Certificate + Free Sale Certificate
  • Sterilization certificate (applicable to sterile medical devices)

What additional requirements are there for special medical device exports?

The following three types of products require special supervision:

• Implantable devicesEU requires 10-year clinical follow-up data
• Drug-containing devicesMust simultaneously meet drug registration requirements
• Radioactive equipmentProvide radiation safety documentation

How to evaluate the actual service capabilities of an agency company?

Proposal to pass35. Data dimensionScreening:

• Regulatory response speedAbility to promptly interpret regulatory updates such as MDR/IVDR
• Emergency handling capabilitiesPresence of successful cases dealing with FDA unannounced inspections
• How to handle customs clearance delays?Establishment of a multinational expert pool (e.g., CE auditors, FDA consultants)

What are the tax incentives for medical device exports?

Key points of the latest 2025 policies:

• Export tax refundThe rate remains unchanged at 13%
• R&D expense super-deduction ratio increased to 120%
• Small and medium-sized medical device enterprises can apply for cross-border service VAT exemption

How to handle quality complaints in overseas markets?

Proposal to establishThird Level Response Mechanism:

• Level 1: Provide technical documentation within 72 hours
• Level 2: Complete root cause analysis within 14 working days
• Level 3: Activate quality traceability system to locate production batches