Ecuador Regulatory News

The Ecuadorian National Agency for Regulation, Control, and Health Surveillance (ARCSA) has issued a resolution introducing new reforms to the technical sanitary regulations for the registration of he...

The Ecuadorian National Agency for Regulation, Control, and Health Surveillance (ARCSA) has issued a resolution introducing new reforms to the technical sanitary regulations for the registration of health products. The reform, which is part of a broader initiative to streamline administrative processes. 

The resolution, ARCSA-DE-2025-xxx-DASP, is built upon the Ecuadorian Constitution's commitment to public health and the authority granted to the nation's health agency. This includes maintaining conformity with national laws and international treaties, such as the Andean Decision 833, which mandates mandatory sanitary notifications for cosmetic products. 

Key Changes Introduced:

1. Product Certification and Documentation Requirements:
   The updated regulations call for more robust documentation for product registration and sanitary notification. Among the mandatory requirements are technical product sheets and manuals, which must include key details such as product names, intended uses, specifications, and production processes. For some products, especially medical devices, additional certifications and approvals are necessary, including those from the Comité de Ética de Investigación en Seres Humanos (CEISH) for in-vitro research use products.

2. New Definition for In-Vitro Use Products:
   In a significant update, a new definition for "Research Use Only" (RUO) products has been added to the regulatory framework. These products, intended solely for scientific or technological research, will now require specific documentation to ensure they are not used for clinical or diagnostic purposes. This includes manufacturer certifications, technical inserts, and ethical approval from research committees.

3. Enhanced Procedures for Registration:
   The resolution also introduces clearer procedural steps for obtaining sanitary certification. Applicants must submit their product documents via the Ventanilla Única Ecuatoriana (VUE), Ecuador's online platform for regulatory submissions. The process includes an official payment order and a defined timeline for submission and correction of any issues that arise during the review.

4. Streamlined Importation Controls:
   Products imported into Ecuador will now face more streamlined controls, with up to 10 products allowed per registration application if they share the same classification. This change is part of a broader effort to facilitate trade while maintaining high standards of product safety.

5. Monitoring and Future Reforms:
   The ARCSA has been tasked with continually reviewing the impact of these regulations, ensuring they align with national goals for economic competitiveness and transparency in regulatory procedures. The Comité de Comercio Exterior (Foreign Trade Committee) is empowered to periodically assess the implementation and efficiency of the new regulatory framework.

6. New Product Documentation Guidelines:
   The reform has introduced detailed guidelines for the documentation required for products, including:

   • A technical sheet or user manual detailing product specifications, intended uses, and more.

   • A certificate of origin and clinical studies where applicable.

   • Raw material analysis documentation, which should include sanitary notifications or certificates as evidence for the use of such materials in product manufacturing.

   • For medical devices and in-vitro products, manufacturers must include specific compliance documents, such as ethical approvals and institutional certifications.

7. Public Consultation on the Reform:
   In line with Ecuador's commitment to transparency and stakeholder engagement, the public consultation period for the reform will run from July 4, 2025 to August 1, 2025. During this period, stakeholders can submit their observations through the designated collection format via email at consulta.normativa@controlsanitario.gob.ec. This initiative ensures that the public, industry professionals, and other stakeholders have a chance to contribute feedback on the new regulatory changes before they are finalized.

In a major regulatory move aimed at strengthening public health safeguards, the National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) has issued Resolution ARCSA-DE-2024-058-DASP,...

In a major regulatory move aimed at strengthening public health safeguards, the National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) has issued Resolution ARCSA-DE-2024-058-DASP, enacting new technical regulations for the registration, control, and surveillance of general-use medicines. The regulation will officially enter into force on June 30, 2025. This resolution aligns with Ecuador’s constitutional mandate to guarantee access to safe, effective, and high-quality medicines, reinforcing compliance with international standards set by the World Health Organization (WHO) and the Andean Community (CAN).

Key Highlights of the New Regulation:

• Mandatory Registration: All pharmaceuticals intended for human use must obtain and maintain a sanitary registration certificate to be legally manufactured, imported, or sold in Ecuador.

• Stricter Quality Controls: Comprehensive guidelines have been introduced for good manufacturing practices (GMP), bioequivalence studies, and pharmacovigilance.

• Fast-Track Approvals: Medications already approved by WHO-recognized authorities may qualify for an expedited homologation process.

• Enhanced Post-Market Surveillance: ARCSA will conduct routine inspections and laboratory analyses to verify compliance with safety and quality standards.

• Labeling and Transparency Requirements: Pharmaceutical companies must adhere to updated guidelines on packaging, labeling, and patient information leaflets, ensuring clear and accurate information is available to consumers.

The resolution will take full effect on June 30, 2025, six months after its signing on December 30, 2024. ARCSA has urged all stakeholders in the pharmaceutical industry, including manufacturers, importers, and healthcare providers, to adapt to these changes to enhance Ecuador’s public health framework. For further details, you can find the Resolution here (in Spanish). 

The Republic of Ecuador has announced significant amendments to its Sanitary Technical Regulation on Good Practices for Storage, Distribution, and/or Transportation for pharmaceutical companies and ma...

The Republic of Ecuador has announced significant amendments to its Sanitary Technical Regulation on Good Practices for Storage, Distribution, and/or Transportation for pharmaceutical companies and manufacturers of medical devices for human use. This update is formalized by Resolution No. ARCSA-DE-2024-047-DASP, issued by the National Agency for Sanitary Regulation, Control, and Surveillance (ARCSA) on December 12, 2024. The regulation will take effect six months after its signing, as stipulated in the addendum from the Ministry of Production, Foreign Trade, Investment, and Fisheries, ensuring that stakeholders have sufficient time to comply.

Key Details of the New Sanitary Technical Regulation:

Purpose and Scope of the Updated Regulation

The updated regulation focuses on modernizing certification procedures, strengthening operational requirements, and ensuring compliance obligations for establishments engaged in the storage, distribution, and transportation of pharmaceutical products and medical devices. It is aligned with international best practices to protect public health and improve regulatory oversight.

Key Amendments in Certification Procedures:

1. Certification and Compliance Enhancements:

   • Revised procedures for obtaining, renewing, and modifying certifications, including stricter documentation and validation requirements.

   • Introduction of transitional provisions allowing micro and small enterprises to undergo certification without inspection fees for a period of three years.

2. Operational Standards and Safety Measures:

   • Increased emphasis on temperature control and environmental mapping, requiring facilities to monitor and document conditions for at least seven days during initial validation and repeat the process every three years.

   • Enhanced requirements for security measures to prevent unauthorized access to storage facilities.

3. Third-Party and Subcontracting Processes:

   • Clear guidelines for facilities that outsource storage, distribution, or transportation, mandating formal notification to ARCSA, supported by signed contracts with certified third party providers.

   • Requirements for transparency and traceability of subcontracted services, ensuring compliance with regulatory norms.

4. Updated Definitions and Repealed Sections:

   • Inclusion of new terms such as “Notification of Contracted Services”, describing the obligations of facilities using external service providers.

   • Repeal of outdated sections, including those relating to certifications issued by accredited inspection bodies, as ARCSA assumes direct responsibility for certifications.

5. Audit and Inspection Framework:

   • Mandatory periodic audits during the validity of certifications to verify adherence to Good Practices and the conditions under which certifications were granted.

6. Labeling and Traceability Improvements:

   • New requirements for product labeling, specifying details such as product name, batch/lot number, expiration date (where applicable), and storage conditions.

   • Temperature-controlled products must have documented proof of compliance throughout the supply chain, including transportation.

Implementation Timeline

The Regulation will enter into force on June 12, 2025, ensuring a structured transition period. This timeline allows stakeholders to adapt their operations to the new requirements.

This amendment reflects Ecuador’s commitment to enhancing its regulatory framework for pharmaceuticals and medical devices. Stakeholders are advised to thoroughly review the regulation which can be found here (in Spanish).

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) in Ecuador has released Version 2.0 of the External Instruction Document, which contains updated requirements for the reg...

The National Agency for Regulation, Control, and Sanitary Surveillance (ARCSA) in Ecuador has released Version 2.0 of the External Instruction Document, which contains updated requirements for the registration, re-registration, and modification of sanitary notifications for industrial hygienic products, hospital disinfectants, and food-grade disinfectants. 

Expanded Scope and New Product Categories

The latest version introduces additional product categories to the regulation:

• Hygienic disinfectants for hospital use.

• Food grade disinfectants. 

New Labeling and Reference Codes

To facilitate compliance, the guidelines now include a dedicated labeling guide for all regulated products:

• Industrial use: Reference Code N129PHI

• Hospital use: Reference Code N129PHHOP

• Food Grade use: Reference Code N129PHFV

This structured approach aims to simplify product identification and regulatory processes for manufacturers and importers.

Enhanced Compliance Requirements

Version 2.0 introduces more stringent standards for product efficacy and stability studies:

• Efficacy Studies: Applicants must substantiate the properties of their products with comprehensive efficacy data.

• Stability Studies: The document mandates stability testing for three different product batches, alongside accelerated stability studies adhering to the latest norms.

These changes reflect ARCSA's focus on ensuring product safety and maintaining quality standards throughout a product’s lifecycle.

Development of the Guidelines

The original guidelines were created in June 2020, but significant updates in December 2024 reflect ongoing efforts to improve regulatory oversight. Key changes include:

• Updated government branding on official documents.

• Clearer processes for modifying sanitary notifications.

• New labeling and study requirements to align with international best practice.

Regulatory Transparency and Accessibility

ARCSA emphasizes that this document is for its intended use only and that stakeholders must always consult the latest version available in the institutional repository. Printed or copied versions are considered uncontrolled and may not contain the latest updates.

A Step Forward in Hygiene and Safety

The revisions aim to streamline the registration process, enhance public safety, and provide clarity for stakeholders navigating the regulatory landscape. The Agency encourages manufacturers, importers, and distributors to familiarize themselves with the updated requirements and ensure full compliance by consulting the institutional repository. For further details, the External Instruction Document can be found here (in Spanish).

Ecuador has recently updated its technical regulation on paints, replacing the existing standard with RTE 061 (2R). The new regulation, which addresses a wide range of paints and coatings, introduces ...

Ecuador has recently updated its technical regulation on paints, replacing the existing standard with RTE 061 (2R). The new regulation, which addresses a wide range of paints and coatings, introduces updated requirements aimed at ensuring higher safety and quality standards for products manufactured or imported into the country. Companies operating in this sector, whether domestically or internationally, should be aware of the significant changes brought about by this regulation.

Key Changes in RTE 061 (2R)

1. Lead Content Limits
   One of the most important updates in RTE 061 (2R) is the establishment of stricter lead limits for paints. The regulation sets new maximum allowable concentrations of lead in paint formulations, aiming to reduce exposure to this hazardous substance. Companies will need to adjust their formulations to comply with these lower thresholds to avoid penalties and ensure consumer safety.

2. Labeling Requirements
   The revised Regulation introduces new labeling requirements for paints and coatings. Manufacturers and importers must ensure that their products display clear and accurate information, such as product composition, safety warnings, and instructions for use. The new labeling requirements aim to increase transparency and provide consumers with essential information to make informed choices.

3. Conformity Assessment Procedure
   The new conformity assessment procedure under RTE 061 (2R) outlines the steps that manufacturers and importers must follow to demonstrate compliance with the regulation. This process includes product testing and certification to confirm that paints meet the established standards for lead content and other safety criteria. Companies will need to familiarize themselves with the updated procedures to ensure seamless market access.

Implications for Paint and Coating Companies

The adoption of RTE 061 (2R) will have significant implications for paint manufacturers and importers in Ecuador. Companies should review their product formulations and labeling practices to ensure compliance with the revised regulation. Non-compliance could result in fines, product recalls, or market access restrictions.

For exporters, it is crucial to understand that these changes apply not only to locally produced paints but also to imported products. International manufacturers wishing to sell their paints in Ecuador will need to meet the same stringent standards as domestic companies.

Next Steps for Compliance

To comply with RTE 061 (2R), companies should:

• Review and adjust formulations to meet the new lead limits.

• Update product labels to reflect the revised requirements.

• Prepare for updated conformity assessment procedures, which may involve additional testing and certification processes.

The full text of RTE 061 (2R) can be accessed through the World Trade Organization's website here.

On July 24, 2024, Ecuador's regulatory authority, the Agency for Regulation, Control, and Sanitary Surveillance (ARCSA), introduced a new resolution amending its 2018 regulations on disinfectant produ...

On July 24, 2024, Ecuador's regulatory authority, the Agency for Regulation, Control, and Sanitary Surveillance (ARCSA), introduced a new resolution amending its 2018 regulations on disinfectant products. These changes affect the process for obtaining Sanitary Notifications for several categories, including:

• Hygiene products for industrial use

• Hospital disinfectants

• Food-grade disinfectants

Key Changes to the Regulations

The revised regulations also establish procedures for obtaining the Certificate of Free Sale and the Sanitary Certificate of Export, while outlining specific requirements for the supervision of the products. These new criteria apply to the manufacturing, storage, distribution, sale, and import of disinfectant products, ensuring stricter control and monitoring.

The updated regulations will officially come into force on January 24, 2025, allowing a six-month transition period for businesses to adapt to the new requirements.

Impact on Businesses

These changes aim to improve product safety and quality by ensuring that disinfectants used in industrial, hospital, and food-related environments meet Ecuador's public health standards. Companies involved in the manufacture or distribution of these products should familiarize themselves with the new regulations and ensure compliance to avoid disruptions to their operations.

For additional guidance, businesses can contact ARCSA or seek regulatory assistance to effectively manage these adjustments.

The Ecuadorian Institute of Standardization (INEN) has implemented Technical Regulation 089, "Toy Safety," to improve the safety of toys in the country. This regulation applies to all new toys, both ...

The Ecuadorian Institute of Standardization (INEN) has implemented Technical Regulation 089, "Toy Safety," to improve the safety of toys in the country. This regulation applies to all new toys, both locally manufactured and imported, intended for children under the age of 14.

RTE INEN 089 sets strict guidelines to ensure that toys meet essential safety requirements, focusing on mechanical and physical properties, flammability and migration of certain elements. The regulation requires clear and accurate labelling, including product name, manufacturer and importer details, country of origin and safety warnings.

This initiative aims to protect children from potential hazards associated with substandard or unsafe toys and to prevent misleading practices. The regulation is in line with international standards such as NTE INEN-ISO 8124.

By adhering to these guidelines, manufacturers and distributors will demonstrate their commitment to child safety and potentially gain greater consumer trust and market differentation.