Ingresar
Ecuador Regulatory Reform: Imports with Sanitary Registration Certificates
By Pedro Córdova Balda, Efrén Jurado & Daniela Coral, Robalino
Pleno del Comité de Comercio Exterior (COMEX), through Resolution No. 017-2025, amended Article 4 of Resolution COMEXI 376-2007 with the purpose of ensuring that Sanitary Registration Certificates (also known as Marketing Authorizations) may only be used for importation when they have been formally authorized by ARCSA.
Key Points
Any form of endorsement, assignment, or transfer of Sanitary Registration Certificates as prior control documents is expressly prohibited when these have not been processed and authorized by ARCSA in accordance with the current sanitary regulations.
Two Key Deadlines
For regulatory entities (SENAE–ARCSA):
A 30-day period, counted from December 9, 2025, is granted to coordinate and adjust operational and regulatory processes necessary for the proper implementation of the reform.
In this regard, it is essential for ARCSA to issue specific regulations enabling the formal inclusion of importers in Sanitary Registrations.
For foreign trade operators:
A 120-day period, starting on December 9, 2025, is granted to regularize any use of RS or NSO belonging to a different holder.
After this period, only registrations with ARCSA's express authorization in favor of the importer will be accepted.
You may find the resolution at the following link.
Robalino
Robalino: Innovation and Excellence in Ecuador
Robalino stands out in the Ecuadorian legal advisory landscape as a pioneering firm in merging legal services with consulting. With a disruptive approach and a forward-thinking vision, the firm has quickly positioned itself as a strategic ally for businesses of all sizes and sectors, serving a broad range of clients, from startups to large multinational corporations.
What sets Robalino apart?
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Our Key Strengths
Protection of Intangible Assets: Robalino is the ideal partner for companies seeking to properly register and protect their trademarks, patents, industrial designs, and other intangible assets.
Strategic Advisory: Robalino offers a strategic approach, enabling clients to make informed decisions and optimize their operations from both a legal and business consulting perspective.
Innovation and Adaptation: The firm stays at the forefront of current trends, offering innovative solutions tailored to each client's specific needs.
Robalino provides exceptional advisory services. Its commitment to excellence, innovation, and client satisfaction has established it as a market leader in Ecuador. The firm is also recognized internationally.
