Ecuador - 1.2 Regulatory Departments & Quality Control

Regulatory Departments & Quality Control 

The Technical Directorate of Standardization plans, organizes, directs, controls and evaluates the quality, safety, and security parameters of the products and services that are marketed in the country. That is, it is responsible for the formulation and study of voluntary technical regulatory documents, which are approved by consensus in a technical committee for the use and application of interested parties. There are different Ecuadorian quality certifications and mandatory and voluntary regulations that can be adopted by organizations depending on the company's business model, etc. 

ISO Standards  (see: Ecuador SEA Accreditation) 

ISO standards have several families and diversified branches to adapt to different companies and their different areas such as quality, environment, social responsibility and risk management and safety. 

Despite being established by the International Standardization Organization (ISO), the national certifier of these regulations is the Ecuadorian Institute of Standardization. 


Good Manufacturing Practices aim to establish conditions and requirements that ensure safety and hygiene in the food production chain. The entity in charge of evaluating this certification is the National Agency for Health Regulation, Control and Surveillance (ARCSA) 


The Phyto and Zoosanitary Regulation and Control Agency AGROCALIDAD is the entity in charge of the regulation and control of the health of the agricultural sector and the safety of food in primary production, with the objective of contributing to the sustained increase in the productivity and competitiveness of the agricultural sector, as well as the quality of life of agricultural producers. 

National Public Health Research Institute (INSPI) 

INSPI is a National and International Reference Institution in Research. It is the state agency in charge of the execution of Research, Science, Technology and Innovation and is the National Reference Laboratory that provides specialized services in public health, within the framework of the National Health Policy and Health Research. INSPI currently has 10 National Reference Laboratories, with its headquarters in Guayaquil and 2 zones in Cuenca and Quito. 

Lines of investigation 

The lines of research are the thematic axes, which include a set of objectives, policies and scientific-technical methodologies aimed at solving public health problems identified in research areas such as: 

• Communicable Diseases 

• Non-communicable diseases 

• Environment, Nutrition and Toxicology 

• Systems and Technologies in Human Health 

• Population and Public Health 

Research Centers 

The research centers are units recognized by the institution, with history and infrastructure; where projects can be articulated with various groups and research methodologies. The centers are: 

• Multidisciplinary Research Center (CIM) “Dr. “Ernesto Gutiérrez Vera” 

• Research Center for Infectious and Vector Diseases “CIREV” 

• Epidemiology, Geomatics, and Biostatistics Research Center “EpiSIG” 


Certifications obtained. Integrated Quality Management System of the National Public Health Research Institute INSPI – “Dr Leopoldo Izquieta Pérez” 

• ISO 9001:2015 Certification. Quality Management: 

• Research, Development and Innovation Directorate 

• Specialized laboratory services – Liveries 

• Production of Culture Media, Reagents and Dyes 

• National Vector Reference Center 

• National Zoonoses Reference Center 

• Directorate of Promotion and Transfer of Knowledge 


National Public Health Research Institute INSPI 

Quito, Ecuador 

Telephone: 593-(042) 2288097 – 2287428 – 2280405  


Ecuadorian Standardization Service (INEN) 

The Ecuadorian Standardization Service - INEN, INEN, formerly known as the Ecuadorian Institute of Normalization, was created on August 28, 1970. The INEN is the National Standardization Organization of the Republic of Ecuador and is also in charge of technical regulation and metrology. . In 2007, the Ecuadorian Quality System law granted INEN the status of a national technical arm dependent on the Ministry of Industry and Productivity. 

It is a public sector entity at the national level; of a scientific and technological nature; with technical, administrative, operational and financial autonomy. 

In close collaboration with government entities, industry, consumers and academia, INEN is responsible for the development, publication and promotion of Ecuadorian standards and other standardization products. INEN promotes standardization in Ecuador in order to contribute to the national economy, support sustainable development, promote the health, safety and well-being of workers and the public, protect consumers and facilitate national and international trade. 

The mission of INEN is to continually improve the quality of the national productive system and the competitiveness, trust and satisfaction of Ecuadorian society, through standardization, technical regulation, conformity evaluation and metrology processes, adding value with the human talent and complying with legal and regulatory requirements. 

INEN is also a member of the Pan American Standards Commission (COPANT) and the Pacific Area Standards Congress (PASC). INEN is part of the Affiliate Countries Program of the International Electrotechnical Commission (IEC). 


E8-29 Baquerizo Moreno and Diego de Almagro streets 

Building: INEN P.O. Box 01-17-3999 

Quito, DM EC170517 Pichincha 


Tel: +(593 2) 382 5960 / +(593 2) 382 5961 



Ecuadorian Accreditation Service (SAE) 

The Ecuadorian Accreditation Service SAE is the Ecuadorian public body that is responsible for the accreditation of conformity assessment bodies. The SAE provides confidence in the certifications of one of the most popular standards of the international organization ISO: 9001. 

It is located in the city of Quito. The Ecuadorian Accreditation Service is an entity attached to the Ministry of Industries and Productivity. 

SAE is a full member of ILAC, a full member of IAF and a full member of IAAC. 

SAE Accreditation Ecuador is responsible for accreditation, that is, for recognizing the technical competence of the different conformity assessment bodies (OEC). These organizations provide testing, calibration, inspection, or certification services for management systems, people, or products. 

The Minister of Industries or his representative is the one who chairs the Interministerial Quality Committee (CIMC), which gives guidelines and policies to the Quality System. Representatives of the Coordinating Ministers of Production, Environment, Tourism, Agriculture, Health, Transport and Electricity are also part of the CIMC. 

Executive Director: Carlos Echeverría Cueva. Carlos Martín Echevarría Cueva 


Av. Amazonas N38-42 and Juan José de Villalengua 

Quito, Ecuador 

Phone: 593-2 2454393 


National Agency for Health Regulation, Control and Surveillance (ARCSA) 

ARCSA is the technical body in charge of the regulation, technical control and health surveillance of the following products: processed foods, food additives, processed water, tobacco products, medicines in general, nutraceutical products, biological products, processed natural products for medicinal use, medicines homeopathic and dental products; medical devices, biochemical and diagnostic reagents, hygienic products, pesticides for domestic and industrial use, manufactured in the national territory or abroad, for import, export, marketing, dispensing and sale, including those received as donations and products domestic hygiene and personal hygiene absorbents, related to human use and consumption; as well as establishments subject to health surveillance and control established in the Organic Health Law and other applicable regulations, except for those of public and private health services. 


National Agency for Health Regulation, Control and Surveillance «ARCSA» 

Quito, Ecuador 

Telephone: (593)2907 074  


Internal Revenue Service (SRI) 

The Internal Revenue Service (SRI) SRI is a technical and autonomous entity that has the responsibility of collecting internal taxes established by Law through the application of current regulations. Its purpose is to consolidate the tax culture in the country in order to sustainably increase voluntary compliance with tax obligations by taxpayers. The Internal Revenue Service (SRI) offers automatic services that you can access with your username and password. 

• Access code, Keys. 

• RUC. 

• Billing. 

• Facilities. payment. 

• Return. of taxes. 

• Endorsement. of notes. of credit. 

• Certificates. 

• Online payments. 

For more information you can call 1700 SRI SRI or consult the website  You can also visit the Agency Map at: SRI mapa-de-agencias 

Other private certification, analysis, pre-shipment inspection companies accredited in Ecuador, (not limited to): 

• SGS del Ecuador S.A. 

• Cotecna des Ecuador S.A. 

• Inchcape Ecuador S.A. 

• Bureau Veritas Ecuador S.A 


For more information on regulatory departments and quality control laboratories’ contact details, please see the following links:  4.1 Government Contact List and 4.3 Laboratory and Quality Testing Company Contact List



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