North America Markets

Complete FDA regulatory compliance solutions for medical devices and healthcare products.

• 510(k) Premarket Notification
• PMA (Premarket Approval)
• De Novo Classification
• FDA Establishment Registration

Comprehensive Health Canada regulatory pathways for medical device market authorization.

• Medical Device License (MDL)
• Establishment License (MDEL)
• Class II-IV Device Approvals
• Quality Management System

End-to-end COFEPRIS regulatory services for Mexican market entry and compliance.

• COFEPRIS Registration
• Labeling Compliance
• Import Authorization
• Sanitary Registration

Complete regulatory services for medical device registration in Guatemala.

• MSPAS Registration
• Product Classification
• Import Permits
• Market Surveillance

Regulatory pathway for medical devices entering the Panamanian market.

• MINSA Registration
• Technical Documentation
• Local Representation
• Post-market Compliance

Complete medical device registration services for Costa Rican market.

• Health Registry
• Import License
• Quality Certification
• Renewal Services

Regulatory compliance services for medical devices in Nicaragua.

• MINSA Registration
• Product Approval
• Import Authorization
• Market Compliance

Complete regulatory pathway for medical devices in Honduras.

• ARSA Registration
• Technical Documentation
• Import Permits
• Quality Assurance

Regulatory services for medical device market entry in El Salvador.

• DNM Registration
• Product Classification
• Import Licensing
• Compliance Monitoring

Import permit and regulatory services for Caricom markets.

• Ministry of Health Import Permit
• Product Registration
• Customs Clearance
• Market Access Support