Medical Device Import Compliance
Meeting FDA, CE marking, and regional standards.
Medical Device Registration & Documentation
Managing 510(k) submissions, device listing, establishment registration, import certificates.
Medical Device Customs Clearance
HS code classification, duties/tariffs, permits, broker coordination.
Medical Device Supplier Verification & Sourcing
Manufacturing audits, quality
certifications, ISO 13485 compliance checks.
Medical Device Import Documentation & Labeling
UDI labeling, instructions for use,
regulatory documentation.
Medical Device Logistics & Freight Management
International freight forwarding, cold chain logistics, warehouse planning.
Medical Device Import Risk & Quality Management
Quality control inspections, batch testing, risk assessment.
Post-Market Surveillance & Import Compliance Monitoring
Adverse event reporting
and ongoing compliance monitoring.
