FDA 510(k) clearance and EU MDR CE marking follow different regulatory pathways. This guide compares their key requirements, device classifications, documentation, and importer responsibilities to help medical device distributors verify certifications, choose suitable products, and prepare for the U.S. and EU markets.

Importing medical devices from China requires early planning for product classification, market requirements, supplier documentation, customs clearance, and labeling. This guide outlines key compliance steps and common sourcing mistakes to help buyers prepare before placing an order.

China's medical device exports topped $50 billion in 2025 — but 42% of procurement failures trace back to poor supplier vetting. Learn the 5-phase due diligence protocol for choosing a reliable OEM partner, from certification verification to factory audits and red flags to avoid.