{"id":146206,"date":"2026-07-27T12:22:02","date_gmt":"2026-07-27T12:22:02","guid":{"rendered":"https:\/\/my.legal500.com\/guides\/?post_type=comparative_guide&#038;p=146206"},"modified":"2026-07-29T11:23:23","modified_gmt":"2026-07-29T11:23:23","slug":"ecuador-life-sciences","status":"publish","type":"comparative_guide","link":"https:\/\/my.legal500.com\/guides\/chapter\/ecuador-life-sciences\/","title":{"rendered":"Ecuador: Life Sciences"},"content":{"rendered":"","protected":false},"template":"","class_list":["post-146206","comparative_guide","type-comparative_guide","status-publish","hentry","guides-life-sciences","jurisdictions-ecuador"],"acf":[],"appp":{"post_list":{"below_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Meythaler &amp; Zambrano Abogados<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2019\/03\/Meythaler-Zambrano.jpg\"\/><\/span><\/div>"},"post_detail":{"above_title":"<div class=\"guide-author-details\"><span class=\"guide-author\">Meythaler &amp; Zambrano Abogados<\/span><span class=\"guide-author-logo\"><img src=\"https:\/\/my.legal500.com\/guides\/wp-content\/uploads\/sites\/1\/2019\/03\/Meythaler-Zambrano.jpg\"\/><\/span><\/div>","below_title":"<span class=\"guide-intro\">This country specific Q&amp;A provides an overview of Life Sciences laws and regulations applicable in Ecuador<\/span><div class=\"guide-content\"><div class=\"filter\">\r\n\r\n\t\t\t\t<input type=\"text\" placeholder=\"Search questions and answers...\" class=\"filter-container__search-field\">\r\n\t\t\t<\/div>\r\n\r\n\t\t\t\r\n\r\n\r\n\t\t\t<ol class=\"custom-counter\">\r\n\r\n\t\t\t\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly summarize your country's legislative framework for medicinal products (including biologicals), medical devices, food, and food supplements<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>In Ecuador, the health-and-safety framework rests principally on the Constitution of the Republic, the Organic Health Law (Official Register, Supplement No. 423, of 22 December 2006) and its implementing regulations. The Ministry of Public Health exercises stewardship over the National Health System, while the National Agency for Health Regulation, Control and Surveillance (ARCSA), created by Executive Decree No. 1290 (Official Register, Supplement No. 788, of 13 September 2012), is the technical authority responsible for regulating, authorizing, controlling and monitoring products for human use and consumption that are subject to health-and-safety control.<br \/>\nSecondary regulation is organized by category. Medicinal products in general (Resolution ARCSA-DE-2024-058-DASP), biological products (Resolution ARCSA-DE-2024-049-DASP) and medical devices (Resolution ARCSA-DE-2026-003-DASP) each have specific technical regimes governing their research, manufacture, sanitary registration, importation, distribution, advertising and post-marketing surveillance. Processed foods (Resolution ARCSA-DE-2022-016-AKRG) and food supplements (Resolution ARCSA-DE-028-2016-YMIH and its amendments) are subject, as applicable, to sanitary notification, composition and labelling requirements, good practices, operating permits and post-marketing controls.<\/p>\n<p>Other authorities also intervene within their respective competences: the Agency for Quality Assurance of Health Services and Prepaid Medicine (ACESS) in relation to health establishments and services; the Agency for Phytosanitary and Zoosanitary Regulation and Control (Agrocalidad) with respect to primary products and materials of agricultural origin; and the National Council for the Setting and Review of Prices of Medicines for Human Use and Consumption in matters of pricing.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">With regards to medicinal products and medical devices, how is the regulatory process structured in your jurisdiction from R&amp;D through market approval until post-marketing vigilance, and what rules does it follow? Please briefly describe.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The regulatory process follows the product life cycle, but the pathways applicable to medicinal products and to medical devices differ. For medicinal products, the research stage comprises pre-clinical studies and, where applicable, clinical trials in human beings that have first been approved by a Human Research Ethics Committee (CEISH) and authorized by ARCSA, in accordance with Ministerial Agreement No. 00069-2024. For marketing, the holder must obtain a sanitary registration\u2014valid for five years under the Organic Health Law\u2014by submitting a dossier evidencing quality, safety and efficacy, together with compliance with good manufacturing practices, labelling requirements and the conditions applicable to the establishment. Generic medicinal products must additionally demonstrate bioequivalence or bioavailability in the cases required by ARCSA.<\/p>\n<p>Biological products are subject to the specialized regime of Resolution ARCSA-DE-2024-049-DASP, which addresses, among other matters, characterization, comparability where applicable, quality control, traceability and enhanced pharmacovigilance. Once a medicinal product is authorized, the holder must keep the registration in force, manage its variations and renewals, comply with the authorized conditions and operate a pharmacovigilance system to detect, assess and report risks, adverse events and safety signals.<\/p>\n<p>For medical devices, ARCSA applies the regime of Resolution ARCSA-DE-2026-003-DASP (Official Register, Second Supplement No. 286, of 18 May 2026), which replaced Resolution ARCSA-DE-026-2016-YMIH and is built on classification by risk level. The dossier must demonstrate the intended use, safety and performance, and must include the technical documentation, free-sale certificates or equivalents where applicable, evidence of the manufacturer&#8217;s quality management system and labelling. After sanitary registration, the holder must comply with obligations relating to technovigilance (Resolution ARCSA-DE-2023-016-AKRG), traceability, incident reporting, field safety corrective actions and change control.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What is the regulatory process for food supplements, from first notification to the competent authorities until post-marketing vigilance in your country, and what regulations are applicable here? Please briefly describe.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Food supplements must obtain a sanitary notification issued by ARCSA before they can be manufactured, imported and marketed, in accordance with Resolution ARCSA-DE-028-2016-YMIH. As a general rule, the application is filed through the Ecuadorian Single Window (Ventanilla \u00danica Ecuatoriana) and requires information on the holder and the manufacturer, the qualitative and quantitative formula, the manufacturing process, physico-chemical and microbiological specifications, stability or shelf life, storage conditions, the draft label, and support for any permitted nutritional or health claims.<\/p>\n<p>The manufacturer and the establishments involved in the chain must comply with hygiene-and-sanitary requirements, the applicable good practices and hold the corresponding operating permits. ARCSA reviews the documentation and may raise observations before issuing the sanitary notification.<\/p>\n<p>Post-marketing surveillance includes inspections, sampling and laboratory analysis, review of labelling and advertising, handling of alerts or complaints, and control of storage and distribution conditions. In the event of non-compliance, ARCSA may order corrective measures, immobilization or withdrawal of the product, suspension or cancellation of the authorization, and the penalties provided for in the Organic Health Law.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are the ongoing obligations in your country after a marketing authorization for medicinal products has been obtained or a conformity assessment been carried out for medical devices?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Holders must keep the sanitary registration in force and ensure that the marketed product retains the quality, safety, efficacy or performance conditions that supported its authorization. They must process variations and renewals in a timely manner, keep the manufacturer&#8217;s and holder&#8217;s information up to date, observe the authorized manufacturing conditions, and comply with the rules on labelling, storage, transport, distribution and advertising.<\/p>\n<p>As to vigilance, medicinal products are subject to pharmacovigilance (Resolution ARCSA-DE-2025-052-DASP, Official Register No. 218, of 4 February 2026) and medical devices to technovigilance (Resolution ARCSA-DE-2023-016-AKRG). This encompasses the receipt, assessment and reporting of adverse events or incidents, the submission of periodic reports where required, signal detection, traceability, the communication of alerts, and the execution of recalls or field safety corrective actions. Holders must also allow inspections and provide ARCSA with any technical information or samples it may require. The pharmacovigilance rules in force further require the implementation, within eighteen months of their publication, of the MedDRA terminology for the coding of clinical events and of the WHODrug dictionary for medicinal products and vaccines.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Which are the competent national authorities having the regulatory oversight over medicinal products, medical devices, food, and food supplements and what are their respective responsibilities?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The Ministry of Public Health is the national health authority and exercises stewardship, policy-making and general regulation of the health sector. ARCSA, an entity attached to the Ministry, carries out the technical regulation and control of products for human use and consumption: it issues technical rules, grants and administers sanitary registrations and notifications, certifies or controls good practices, grants operating permits, conducts inspections and post-marketing surveillance, and adopts administrative and sanitary measures.<\/p>\n<p>ACESS controls the quality of health services and establishments and participates, within its competences, in areas connected with research in human beings. Agrocalidad intervenes with respect to primary products, inputs and materials of agricultural origin. The National Council for the Setting and Review of Prices of Medicines for Human Use and Consumption, with its Technical Secretariat attached to the Ministry of Public Health, administers the pricing regime in accordance with the Regulation issued by Executive Decree No. 400.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the procedure of challenging regulatory decisions (e.g., denial of marketing authorization) made by the competent regulatory authority in relation to medicinal products, medical devices, and food supplements.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>ARCSA&#8217;s decisions may be challenged in the administrative venue in accordance with the Organic Administrative Code (COA). As a general rule, an appeal (recurso de apelaci\u00f3n) lies within a term of ten days from notification of the act (Article 224 of the COA). This route is optional: under Article 173 of the Constitution, it need not be exhausted before turning to the courts. The extraordinary review remedy (recurso extraordinario de revisi\u00f3n) lies only against acts that have become final and on the exhaustive grounds set out in Article 232 of the COA; its time limits depend on the ground invoked\u2014one year for a manifest error of fact or law, and twenty days for the remaining grounds, counted from the point at which the documents of essential value became known or from the finality of the relevant judgment. If admission is not notified within a term of twenty days, or the remedy is not resolved within one month from admission, it is deemed rejected (Articles 233 and 234 of the COA).<\/p>\n<p>In the judicial venue, jurisdiction lies with the district administrative-litigation courts, and Article 306 of the General Organic Code of Procedure (COGEP) fixes the time for bringing suit. The subjective or full-jurisdiction action, aimed at protecting a subjective right affected by an administrative act, must be filed within a term of ninety days counted from the day following notification of the challenged act. The objective or annulment action, directed at reviewing the legality of general provisions or acts, may be brought within a period of three years counted from the day following its issuance. The distinction matters: the term is counted in working days and the period in calendar days.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the legal framework and the relevant regulatory procedure (e.g., application process, requirements, approval, denial) that applies in your jurisdiction to clinical trials for medicinal products and medical devices.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Clinical trials involving medicinal products and processed natural products for medicinal use are governed principally by the Organic Health Law and by the Regulation issued through Ministerial Agreement No. 00069-2024 (Official Register No. 730, of 27 January 2025), which repealed Ministerial Agreement No. 0075 of 2017, together with the ethical and technical rules applicable to research in human beings. Before the study begins, the protocol must obtain the approval of a Human Research Ethics Committee (CEISH) accredited by the national health authority and, subsequently, the authorization of ARCSA. A sponsor without a seat in Ecuador must designate, as its representative, a Contract Research Organization registered with ARCSA.<\/p>\n<p>The application to ARCSA must include, among other documents, the protocol and its annexes, the informed consent, the investigational product information, pre-clinical and clinical background, good-practice certificates, documents relating to the sponsor, investigator and site, contracts, timeline, budget, adverse-event management plan, and an insurance policy issued by an institution registered in the country, the coverage of which must extend for at least one year after the study is completed. ARCSA reviews the requirements, raises curable observations and issues a technical evaluation report that may authorize the trial, require modifications or deny it. Once the study is authorized, it is entered in the National Registry of Clinical Trials, and ARCSA supervises its conduct, modifications, safety and closure.<\/p>\n<p>Ecuador does not yet have a specific regulation for clinical trials involving medical devices. Until one is issued, ARCSA assesses them using Ministerial Agreement No. 00069-2024 as a reference, with particular features of its own: certification of Good Manufacturing Practices or ISO 13485 for all risk levels, and additional technical documentation depending on the product (accuracy, sensitivity and specificity for in-vitro diagnostics; stability, sterility and biocompatibility for high-risk invasive devices).<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Is there a public database for clinical trials in your country, and what are the rules for publication?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes. ARCSA maintains a publicly accessible National Registry of Clinical Trials, which contains general information on authorized or rejected studies, research sites and contract research organizations. The information published is of a registry nature and does not entail full disclosure of the dossiers or of the study results. In addition, the sponsor must register the trial on an international platform (the WHO ICTRP or an equivalent) before recruiting the first participant, and post-marketing studies are entered in an ARCSA database that is published monthly.<\/p>\n<p>Scientific publication of results does not replace regulatory reporting obligations. Where results are published, the confidentiality of participants, informed consent, scientific integrity and the Organic Law on the Protection of Personal Data must be respected. Undisclosed technical information, trade secrets and protected test data are not freely accessible merely because they were submitted to the authority.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly summarize the rules that must be observed in your jurisdiction when using data from clinical trials?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Health data are sensitive personal data. Their processing must have a valid legal basis and must observe, among others, the principles of purpose, relevance, minimization, security, confidentiality and limited retention set out in the Organic Law on the Protection of Personal Data, whose supervisory authority is the Superintendence for the Protection of Personal Data. In clinical research, the informed consent must describe the use of the data and samples, their recipients, the retention period and the transfers envisaged; where possible, anonymization or pseudonymization techniques and access controls must be applied.<\/p>\n<p>In addition, information submitted to the authority may be protected as undisclosed information or a trade secret (Article 266 of Decision 486 and Article 39.3 of TRIPS). Regulatory exclusivity for test data is recognized under specific conditions, particularly with respect to undisclosed safety and efficacy data submitted for the approval of new chemical entities. The regime is set out in Articles 508 and 509 of the COESCCI and is developed in Resolution ARCSA-DE-2024-023-DASP, as amended by Resolution ARCSA-DE-2025-003-DASP, which redefined a new chemical entity as an active ingredient not previously approved in Ecuador, rather than one never used anywhere in the world. The exclusivity period is five years counted from marketing approval, without this rendering all clinical data protected or preventing preparatory acts or the other uses permitted by the applicable rules.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any trends and\/or legislative proposals in your country on digitizing the process of conducting clinical trials (e.g., digitalization of the application process, decentralization of clinical trials)?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The trend is toward the electronic filing and management of procedures, documents and regulatory communications. Electronic signatures are mandatory in public-sector processes and services under the General Regulation to the Organic Law for Digital and Audiovisual Transformation, and ARCSA channels clinical-trial applications electronically. Ecuador does not, however, yet have a comprehensive and specific framework for decentralized clinical trials.<\/p>\n<p>The use of electronic consent, teleconsultations, remote monitoring, wearable devices or electronic data capture may be permissible if it is provided for in the approved protocol, allows the participant&#8217;s identity and will to be verified, preserves the integrity and traceability of the information, does not reduce medical supervision, and complies with data-protection, information-security and authority- and ethics-committee-reporting obligations.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What are your country's legal requirements for the authorization of manufacturing plants for medicinal products, medical devices, food, and food supplements? Please briefly describe.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Plants and establishments must hold the corresponding operating permit and comply with the technical, sanitary, infrastructure, personnel, documentation and quality-control conditions applicable to their activity. ARCSA may conduct prior and subsequent inspections and require the correction of findings before authorizing or maintaining operations.<\/p>\n<p>Manufacturers of medicinal products and biological products must obtain and maintain Good Manufacturing Practices certification, the validity of which conditions the granting and preservation of the sanitary registration. Manufacturers of medical devices must demonstrate compliance with the quality system and the good practices required by the applicable rules; ISO 13485 certification is often relevant as evidence of the quality management system, where applicable, but its specific enforceability depends on the type of product and the applicable regime.<\/p>\n<p>Processed-food and food-supplement plants must comply with the applicable hygiene-and-sanitary conditions and good practices, implement controls over raw materials, processes, cleaning, traceability, storage and product recall, and obtain the certifications or authorizations that correspond to their category and risk level.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the typical process of distributing medicinal products, medical devices, and food supplements in your country, encompassing, if applicable, the wholesale distribution of products.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Distribution must be carried out by authorized establishments and in respect of products that hold the required sanitary registration or notification. Representation houses may import and wholesale the products of the parties they represent; pharmaceutical distributors and other authorized establishments may import, export, store and distribute the categories provided for in their operating permit.<\/p>\n<p>Establishments that handle medicinal products and certain medical devices must have technical direction where the rules so require, and must comply with the Good Practices for Storage, Distribution and Transport (Resolution ARCSA-DE-002-2020-LDCL). These obligations include traceability, control of suppliers and customers, temperature and humidity conditions, cold chain, and the management of returns, complaints, non-conforming products and market recalls.<\/p>\n<p>Food supplements must be distributed by authorized operators and kept in accordance with the approved conditions. Their transport, storage and sale must prevent contamination, deterioration or alteration of the product and must allow it to be identified and withdrawn where a sanitary alert exists.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the pricing and reimbursement rules, if any, for medicinal products, medical devices, and food supplements in your jurisdiction?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Medicinal products for human use and consumption are subject to the Regulation for the Setting of Prices of Medicines for Human Use and Consumption (Executive Decree No. 400), administered by the National Council for the Setting and Review of Prices. The system contemplates three regimes: the regulated regime, which sets ceiling prices by market segment for strategic and new medicines; the direct-setting regime, which is exceptional and under which the Council unilaterally determines the price, for three years, where the ceiling prices are breached; and the liberalized regime, under which the price is set freely but must be mandatorily notified to the Council. Where applicable, the authority determines ceiling prices or maximum prices; holders may market below the authorized limit but not above it; ARCSA carries out field controls and reports breaches to the Council&#8217;s Technical Secretariat. The Constitutional Court confirmed the validity of this regime in judgment 78-20-IN\/25.<\/p>\n<p>Medical devices and food supplements are not, as a general matter, subject to an equivalent pricing system, and their prices are determined mainly by the market, without prejudice to special rules on public procurement, competition and consumer protection.<\/p>\n<p>Ecuador does not have a general reimbursement system for products dispensed in the private market comparable to that of certain European jurisdictions. Public coverage is articulated mainly through the direct procurement and provision of medicines and devices by the Comprehensive Public Health Network and the social-security institutions, subject to the National Table of Basic Medicines, to institutional protocols and budgets, and to public-procurement procedures, including the corporate reverse auction.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What legislative framework applies to the advertising for medicinal products, medical devices, and food supplements in your country?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Advertising is governed by the Organic Health Law, the technical rules issued by ARCSA and the general rules on consumer protection and unfair competition. For medicinal products, medical devices and homeopathic products, Resolution ARCSA-DE-2024-048-DASP (Official Register No. 727, of 22 January 2025), on the surveillance and control of advertising and promotion, is particularly relevant.<\/p>\n<p>Advertising information must be truthful, clear, verifiable, consistent with the sanitary registration or notification, and must not mislead as to the nature, composition, quality, efficacy, safety or benefits of the product. Advertising of prescription medicines directed at the general public is prohibited; promotion to professionals must be limited to the authorized information and must be scientifically supported. Over-the-counter medicines may be advertised under the required conditions and warnings.<\/p>\n<p>Foods and food supplements may not attribute to themselves therapeutic, preventive or curative properties characteristic of medicinal products, nor use unauthorized claims. ARCSA may order the suspension or withdrawal of advertising, require rectifications and impose penalties.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What laws apply to patents and trademarks for medicinal products, medical devices, and food supplements in your country?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Patents and trademarks are governed principally by Decision 486 of the Andean Community, which establishes the Common Regime on Industrial Property, and by the Organic Code of the Social Economy of Knowledge, Creativity and Innovation (COESCCI) and its General Regulation, which supplement the Community regime domestically. Decision 486 is directly applicable and prevails in the harmonized matters. Ecuador is a party to the Paris Convention, to TRIPS and to the Patent Cooperation Treaty (PCT), which has been in force for the country since 7 May 2001.<\/p>\n<p>The National Service for Intellectual Rights (SENADI) administers industrial-property registrations and procedures in the administrative venue. Disputes may also be heard by the competent courts. Life-sciences products are subject to the general rules on patentability, scope, exceptions and licences. A patent lasts twenty years from the filing of the application (Article 50); therapeutic, surgical and diagnostic methods applied to the human body are not patentable (Article 20(d)), and no new patent may be granted merely for attributing a different use to an already patented product or process (Article 21). Trademark registration is granted for ten years, renewable indefinitely (Article 152), and is subject to cancellation for non-use (Article 165). Sanitary registration is processed independently of the status of industrial-property rights: Ecuador does not apply a patent-linkage system. Added to this are the sanitary requirements on denomination, labelling, advertising and marketing.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe how patent infringements in relation to medicinal products and medical devices are addressed in your jurisdiction, including possible defense strategies and legal proceedings against patent infringements.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The holder may bring an enforcement action before SENADI, in accordance with Articles 238 et seq. of Decision 486 and the COESCCI, against a consummated infringement or an imminent threat. It may request precautionary measures to prevent the importation, manufacture, offer, marketing or distribution of the allegedly infringing product, as well as inspections, immobilization, seizure, withdrawal from commercial channels or other necessary measures. The final decision may declare the infringement and order, in accordance with Article 241, the cessation of the acts, compensation for damages, withdrawal from commercial circuits and destruction of the infringing products, in addition to the applicable penalties. Border measures before the customs authority are also available (Articles 250 to 256 of Decision 486).<\/p>\n<p>Actions may also be brought before the competent courts, including a claim for damages. Administrative decisions may be challenged in the administrative-litigation jurisdiction. An infringement action is time-barred two years after the holder became aware of the infringement or, in any event, five years after it was last committed (Article 244). In the case of process patents, it is for the defendant to prove that the process used differs from the patented one (Article 240). The interpretation and application of Decision 486 must observe the preliminary-ruling case law of the Court of Justice of the Andean Community.<\/p>\n<p>Common defenses include the absence of literal infringement or infringement by equivalents, the failure to reproduce all the elements of the claims, the invalidity or nullity of the patent, lack of standing, and the statutory exceptions\u2014among them acts carried out in the private sphere without commercial purposes or for exclusively experimental purposes, and exhaustion of the right (Articles 53 and 54 of Decision 486). The nullity of the patent may be raised as a defense or brought by way of action before SENADI (Articles 75 et seq. of Decision 486).<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Does your jurisdiction provide for restrictions on the use of trademarks for medicinal products, medical devices, food, and food supplements?<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes. Articles 135 and 136 of Decision 486 prohibit the registration of signs that lack distinctiveness, are descriptive or generic, mislead as to the nature, quality, composition, origin or suitability of the product, or create a likelihood of confusion with earlier rights. In the pharmaceutical sector, care must also be taken to prevent the trademark from being confused with International Nonproprietary Names (INN), active ingredients or other terms whose use must remain available. The Court of Justice of the Andean Community further requires a particularly rigorous comparison between pharmaceutical trademarks, given the risk of dispensing errors. Common particles derived from the INN or the active ingredient are weak elements that cannot be exclusively appropriated, so the comparison focuses on the components that have distinctive capacity.<\/p>\n<p>From a sanitary standpoint, the denomination and presentation of the product must match the information authorized by ARCSA. Trademarks, graphic elements or messages that attribute unauthorized indications or therapeutic, preventive or curative properties, that conceal risks, or that induce improper use may not be used. These restrictions operate without prejudice to the trademark protection granted by SENADI.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly describe the product liability regime for medicinal products, medical devices, and food supplements in your country.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Liability may arise in the administrative, civil, consumer-protection and criminal spheres. Holders of sanitary registrations or notifications, manufacturers, importers, distributors and marketers must ensure that the products placed on the market comply with the required quality, safety, efficacy or performance, labelling and traceability conditions.<\/p>\n<p>The Organic Consumer Protection Law recognizes the right to receive safe goods and truthful information and provides for the joint and several liability of suppliers, manufacturers, importers and distributors for damage caused by defective or dangerous products, with a right of recourse, without prejudice to the general rules of the Civil Code on non-contractual liability (Article 2214), the action for which is time-barred four years after the act was committed (Article 2235). The determination of liability depends on the participation of each operator, the defect or non-compliance, the damage and the causal link; concurrent or joint and several liabilities may exist in the cases provided for by law. Ecuador has not adopted a special strict-liability regime for defective products equivalent to the European one.<\/p>\n<p>ARCSA may impose sanitary measures and administrative penalties, order recalls or suspend authorizations. If the conduct constitutes an offence against public health, criminal liability may also arise for natural and legal persons.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please provide a short overview of risks of liability (criminal liability, serious administrative \/ civil liability) and enforcement practice with regards to medicinal products (including biologicals), medical devices, foods, and food supplements.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Article 217 of the Comprehensive Organic Criminal Code penalizes the marketing, distribution, importation, storage or dispensing of expired medicinal products or medical devices with a custodial sentence of six months to two years; for other expired products for human use or consumption, the sentence is six months to one year. If the perpetrator is a health professional, the sentence is increased to three to five years with professional disqualification and, if consumption causes death, to ten to thirteen years. A responsible legal person is fined thirty to fifty unified basic salaries and dissolved.<br \/>\nArticle 217.1 penalizes with five to seven years&#8217; imprisonment the production, manufacture, marketing, distribution, importation, storage or dispensing of medicinal products, medical devices or products for human use or consumption that are counterfeit or adulterated, lack a sanitary registration or notification, contain inappropriate ingredients or lack active ingredients, or have counterfeit packaging. The sentence rises to seven to ten years if the perpetrator is a health professional, and to ten to thirteen years if death results; a responsible legal person is fined fifty to one hundred unified basic salaries and dissolved. Both offences provide for confiscation of the product for its destruction.<\/p>\n<p>In the administrative venue, ARCSA conducts inspections, sampling, quality controls, advertising surveillance, handling of alerts and coordination of recalls. It may impose fines, confiscation, suspension or cancellation of permits and authorizations, temporary or definitive closure and other sanitary measures. The sanctioning procedure and its challenge are governed by the Organic Administrative Code. In the civil venue, those affected may claim redress for pecuniary and non-pecuniary damage, subject to proof of the defect, damage, causation and liability.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Does your jurisdiction provide for a specific legislative and regulatory framework for digital health applications (e.g., medical apps)? If yes, please briefly describe the relevant framework.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Ecuador does not have a single, comprehensive law applicable to all digital-health applications. The regime depends on the function, intended use and risk of the tool. Applicable rules include, among others, the Organic Health Law, the Organic Law on the Protection of Personal Data, the rules on electronic commerce and electronic signatures, the rules on professional practice and clinical confidentiality, and the rules on telemedicine or the provision of health services where relevant.<\/p>\n<p>Software intended by its manufacturer for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease may be classified as a medical device under Resolution ARCSA-DE-2026-003-DASP and become subject to risk classification, sanitary registration, evidence of safety and performance, technovigilance and change control. General wellness applications that do not have a medical purpose must be assessed on a case-by-case basis and, even where they are not devices, remain subject to data protection\u2014including the General Rule issued by Resolution No. SPDP-SPD-2026-0009-R where they use artificial intelligence\u2014as well as advertising and consumer-protection rules.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Does your jurisdiction provide for laws or certain legal measures to ensure the supply of medicinal products and medical devices, or are such rules envisaged in the future? If yes, please briefly describe those rules.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Yes. The legislation allows for public-procurement mechanisms, exceptional importation and special authorizations to address health emergencies, rare or catastrophic diseases, shortages, donations and other justified public-health needs. Exceptional importation (Resolution ARCSA-DE-016-2020-LDCL) may permit the entry of products without an Ecuadorian sanitary registration, provided the documentary, technical and quality requirements are met and ARCSA authorizes the case.<\/p>\n<p>The institutions of the Comprehensive Public Health Network may procure and distribute medicines and devices in accordance with their competences, tables and protocols, and ARCSA may prioritize or expedite certain regulatory actions in the face of an emergency. These mechanisms do not eliminate the obligations relating to traceability, storage, pharmacovigilance or technovigilance, nor liability for the quality and safety of the imported or supplied product.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Are there any specific compliance standards in your jurisdiction for the marketing of medicinal products and medical devices (e.g., codes of conducts of industry associations, etc.)? If yes, please give a brief overview of the relevant standards.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Mandatory compliance derives principally from the sanitary rules. Before marketing, the product must hold the corresponding sanitary registration; establishments require operating permits and must comply, depending on their activity, with Good Manufacturing, Storage, Distribution and Transport Practices, pharmacovigilance or technovigilance, traceability, promotion and advertising rules, and reporting and recall obligations.<\/p>\n<p>The rules on competition, consumer protection, data protection, public procurement and the prevention of corruption also apply. The codes of industry associations\u2014such as those of the IFPMA and its member associations or, for medical devices, those of AdvaMed and MedTech Europe\u2014and companies&#8217; global policies may set additional standards on interaction with health professionals, samples, sponsorships, events, donations and transparency. Such codes are voluntary unless they have been incorporated contractually or reproduce legal obligations, but they are often relevant as a reference for good practices. Ecuador does not have a mandatory transparency rule on transfers of value to health professionals equivalent to Sunshine Act-type regimes.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please state 3-5 key decisions by courts or regulatory authorities that have been issued recently and that are relevant for the life sciences sector.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The most relevant recent actions come from the regulatory authority and, in the judicial venue, from the Constitutional Court:<\/p>\n<p>\u2022 Resolution ARCSA-DE-2026-003-DASP (Official Register, Second Supplement No. 286, of 18 May 2026): replaced the regime for the sanitary registration, control and surveillance of medical devices and related products, emphasizing risk classification, technical documentation and post-marketing obligations.<\/p>\n<p>\u2022 Resolution ARCSA-DE-2025-052-DASP (Official Register No. 218, of 4 February 2026): issued the replacement rules for the National Pharmacovigilance System, reinforcing the responsibilities of holders, establishments and professionals in the detection, assessment and communication of risks associated with medicinal products.<\/p>\n<p>\u2022 Resolution ARCSA-DE-2024-049-DASP (Official Register No. 726, of 21 January 2025): established the technical regime for obtaining the sanitary registration and for the control of biological products, including specific requirements on quality, safety, efficacy, traceability and vigilance.<\/p>\n<p>\u2022 Resolution ARCSA-DE-2024-023-DASP (Official Register No. 604, of 19 July 2024), as amended by Resolution ARCSA-DE-2025-003-DASP: regulated the exclusivity period for undisclosed test data of pharmaceutical products containing new chemical entities and redefined that concept.<\/p>\n<p>\u2022 Constitutional Court, judgment 78-20-IN\/25: dismissed the public action of unconstitutionality brought by the pharmaceutical industry against the Regulation for the Setting of Prices of Medicines and confirmed the validity of the direct-setting regime, classifying it as a regulatory rather than a sanctioning measure.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">What, if any, are the key legal and regulatory trends in your jurisdiction with regards to the digitalization of the local healthcare system and with regards to the use of artificial intelligence in the life sciences sector? Please briefly describe.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>Digitalization is advancing through the use of electronic regulatory procedures, electronic prescriptions and signatures, electronic health-record systems, telemedicine and health-surveillance tools. Its implementation must observe the validity of electronic signatures, clinical confidentiality, interoperability, record retention and the Organic Law on the Protection of Personal Data, especially given that these are sensitive data. The Organic Law for the Strengthening of Cybersecurity (Official Register, Fifth Supplement No. 290, of 22 May 2026) added obligations for the management and notification of incidents for operators of essential services and critical digital infrastructure, and amended, among other rules, the Organic Law on the Protection of Personal Data. MINTEL is the governing body, the National CSIRT handles incidents, and infringements are classified as minor, serious and very serious, with fines that, for private entities, are calculated on the previous year&#8217;s turnover.<\/p>\n<p>Ecuador does not yet have a general artificial-intelligence law or a sectoral AI regime applied to health; bills are before the legislature. There is, however, binding regulation of cross-cutting scope: by Resolution No. SPDP-SPD-2026-0009-R, of 12 February 2026, the Superintendence for the Protection of Personal Data issued the General Rule for Guaranteeing the Right to Personal Data Protection in the Use of Artificial Intelligence Systems, which is mandatory for those who develop, train, implement, deploy or provide AI systems that process the data of Ecuadorian data subjects, regardless of where the provider or the infrastructure is located. It requires prior impact assessments and risk management, security measures and transparency duties, and reinforces the right not to be subject to decisions based solely or partly on automated evaluations (Article 20 of the Organic Law on the Protection of Personal Data). Outside that scope, AI systems are assessed under the rules on professional liability, product safety, advertising, consumer protection and, where the software has a medical purpose, medical-device regulation.<\/p>\n<p>The main areas of regulatory attention are the quality and representativeness of data, clinical validation, the explainability of automated decisions, human oversight, cybersecurity, the management of algorithm updates and the attribution of liability. The Superintendence&#8217;s rule adds powers to audit AI systems and to impose corrective or precautionary measures, with the sanctioning regime of the Organic Law on the Protection of Personal Data. Legislative bills and future regulatory guidance on AI should be monitored, since their content and status may change during the legislative process.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\t\t\t\t\t<li class=\"question-block filter-container__element\">\r\n\t\t\t\t\t\t<h3 class=\"filter-container__match-html\">Please briefly highlight 3-5 key developments or trends in your jurisdiction with regards to the life sciences sector as you consider them relevant. This may include legislative proposals, market activity, etc.<\/h3>\r\n\t\t\t\t\t\t<button id=\"show-me\">+<\/button>\r\n\t\t\t\t\t\t<div class=\"question_answer filter-container__match-html\" style=\"display:none;\"><p>The main developments and trends are:<br \/>\n\u2022 Regulatory update on medical devices: Resolution ARCSA-DE-2026-003-DASP, published in the Second Supplement of Official Register No. 286 of 18 May 2026, modernizes the requirements for registration, risk classification, technical documentation and technovigilance.<\/p>\n<p>\u2022 Strengthening of vigilance and of complex products: the new rules on pharmacovigilance, biological products and test data raise compliance requirements throughout the entire life cycle.<\/p>\n<p>\u2022 Comprehensive cancer care: the Organic Law for the Comprehensive Care of Cancer (Official Register, Seventh Supplement No. 236, of 4 March 2026) creates the National Cancer Registry, the National Cancer Committee and a specialized national network, and introduces mechanisms to expedite the procurement of oncological medicines. Its implementing regulation must be issued within one hundred and eighty days of publication.<\/p>\n<p>\u2022 Digitalization, AI and cybersecurity: the use of telemedicine, electronic health records, AI tools and software with a medical purpose is growing. The General Rule on personal data and artificial intelligence (Resolution No. SPDP-SPD-2026-0009-R) and the Organic Law for the Strengthening of Cybersecurity require the integration of sanitary regulation, data protection and cybersecurity.<\/p>\n<p>\u2022 Access and supply: challenges persist regarding public procurement, availability, pricing and timely supply, together with greater regulatory attention to exceptional importation, traceability and therapeutic continuity.<\/p>\n<\/div>\r\n\r\n\r\n\t\t\t\t\t<\/li>\r\n\r\n\t\t\t\t\r\n<div class=\"word-count-hidden\" style=\"display:none;\">Estimated word count: <span class=\"word-count\">5982<\/span><\/div>\r\n\r\n\t\t\t<\/ol>\r\n\r\n<script type=\"text\/javascript\" src=\"\/wp-content\/themes\/twentyseventeen\/src\/jquery\/components\/filter-guides.js\" async><\/script><\/div>"}},"_links":{"self":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide\/146206","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/comparative_guide"}],"about":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/types\/comparative_guide"}],"wp:attachment":[{"href":"https:\/\/my.legal500.com\/guides\/wp-json\/wp\/v2\/media?parent=146206"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}