We’ve built strong business partnerships with our ecuatorian counterparts to ensure you obtain the best assistance through the registration process with the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA), Ecuador’s medical device market regulator.
Your business needs to choose carefully and consider competence, expertise, and reputation when appointing a regulatory representative. We meet all organizational requirements set by regulatory authorities.
What we can do for you:
• Act as a liaison between your business and ARCSA
• Submit registration dossiers
• Own and keep your registrations
• Work in coordination with distribution partners
• Submit registration modifications and renewals
• Comply with warehouse procedures
• Adverse event reporting. Maintain records of technical complaints
• Post-market surveillance
From nail polish to an electroencephalograph and everything in between, we’re ready to ease your access to our markets.
• Class I, II, III, and IV medical devices
• In vitro diagnostic medical devices
• Biomedical equipment
• Drugs
• Biologics
• Dietary supplements
• Cosmetics
• Personal hygiene products
• House cleaning products
• Food
Send us a message using the form below, we will get back to you as soon as possible.
You can also contact us at [email protected] and on WhatsApp by clicking here or scanning the QR code with your smartphone.
