Launch in Ecuador Without the Guesswork

Rebexa simplifies regulatory approvals with ARCSA and MAGA, guiding you through every step of the submission and post-market process.

Rebexa Ecuador, ARCSA and MAGA for Healthcare and Agricultural Products.

Ecuador’s regulatory environment is evolving, with the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA) overseeing a wide range of healthcare products. For veterinary and agricultural-related products, Rebexa works directly with the Ministerio de Agricultura y Ganadería (MAGA) to ensure proper classification, documentation, and approval.

Rebexa provides full support to navigate the changing documentation rules, labeling requirements, and registration timelines of both agencies helping you avoid rejections, delays, and unnecessary costs.

What We Handle

  • Product classification and regulatory roadmap
  • Dossier preparation and document legalization
  • ARCSA and MAGA registration submission and tracking
  • GMP and labeling compliance
  • Variation handling and renewal services
  • In-country legal and technical representation

We Support

  • Human pharmaceuticals
  • Medical devices and diagnostics
  • Veterinary products
  • Food supplements and personal care products
  • Disinfectants and household hygiene products

Why Choose Rebexa

  • In-depth ARCSA and MAGA process experience
  • Bilingual regulatory consultants
  • Hands-on support for every registration type
  • Regional continuity across the Andean region

Enter Ecuador with a Regulatory Edge.

Partner with Rebexa to streamline your registration and stay compliant.