Ecuador is a growing Latin American market with increasing healthcare needs and demand for pharmaceuticals, medical devices, and health products.
The National Agency for Health Regulation, Control and Surveillance (ARCSA – Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) is the national regulatory authority responsible for the registration, importation, distribution, quality control, pharmacovigilance, and post-market surveillance of medicines, medical devices, cosmetics, and biologics in Ecuador. ARCSA requires product registration, import permits, GMP compliance, quality certificates (CPP, GMP), Spanish labelling, and local sanitary registration holder representation. MedWisdom LifeScience provides expert regulatory affairs support to help global manufacturers navigate ARCSA requirements, prepare compliant dossiers, secure timely approvals, and achieve efficient market entry and sustained compliance in this emerging Latin American market.
Get Ecuador Compliance Support
Preparation of regulatory dossiers (CTD format), supporting documents (stability, preclinical/clinical data, GMP/CPP certificates), and quality review for ARCSA submissions.
End-to-end support for ARCSA registration of medicines, medical devices, biologics, and health products in Ecuador.
Assistance with ARCSA import/export authorizations, sanitary import permits, batch release certificates, and customs documentation.
Guidance on ARCSA GMP requirements, quality assurance documentation, certificate support, and preparation for inspections.
Setup of pharmacovigilance systems, adverse event reporting to ARCSA, periodic safety reporting, and risk management in Ecuador.
Support for post-market monitoring, vigilance reporting, field safety corrective actions, and compliance with ARCSA post-registration requirements.
Spanish labelling review, ARCSA-specific requirements (patient information, packaging), mock-up preparation, and compliance support.
Support for local sanitary registration holder/agent requirements, ARCSA liaison, regulatory follow-up, and ongoing compliance management in Ecuador.
Strategic market entry planning, ARCSA pathway guidance, regulatory intelligence on Ecuador’s requirements, and risk mitigation support.
Partner with Medwisdom for expert, reliable, and compliant regulatory support in Ecuador — from ARCSA product registration and import permits to pharmacovigilance, Spanish labelling, and sustained Latin American market access.
Contact Our Ecuador Regulatory Experts