‍Clinical Trials in Ecuador: 2025 Regulatory Guide for Medical Devices

Preparing for First-In-Human Studies

‍Executive Summary: What You Need to Know

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This report outlines the regulatory framework for conducting First-in-Human (FIH) medical device clinical trials in Ecuador. As of 2025, Ecuador offers a strategic environment for clinical research characterized by the US Dollar economy, diverse patient populations, and a modernized legal framework aligned with PAHO/WHO standards.

For international sponsors (Startups and MedTech companies), success depends on navigating a "double-lock" approval system involving the Comité de Ética de Investigación en Seres Humanos (CEISH) and the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA). Key compliance requirements for 2025 include the new Unique Traceability Code (CUT) for investigational products and strict adherence to Acuerdo Ministerial 0069-2024.1

1. Why Choose Ecuador for Medical Device Trials?

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1.1 The Strategic Advantage

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Ecuador has emerged as a prime jurisdiction for early-feasibility and FIH studies due to the "European Bottleneck." The transition to the MDR (Medical Device Regulation) in Europe has increased costs and timelines, prompting sponsors to seek alternative data generation sites that are accepted by the FDA.

  • FDA Acceptance: Data generated in Ecuador is valid for US regulatory submissions (IDE, 510(k)) if conducted under Good Clinical Practices (GCP).
  • Cost Efficiency: Operational costs are typically 30-40% lower than in the US or EU, driven by lower site fees and competitive professional honorariums.4

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1.2 The 2025 Regulatory Update

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The regulatory landscape is governed by the Acuerdo Ministerial 0069-2024. This regulation modernized the approval process, establishing clear timelines and responsibilities for sponsors. It emphasizes transparency, patient safety, and the mandatory registration of all trials in the national database.1

2. Legal Framework and Compliance Hierarchy

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2.1 The "Double-Lock" Approval System

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To start a trial, sponsors must unlock two sequential regulatory gates:

  1. Ethical Approval (CEISH): Focuses on patient rights, informed consent, and bioethics.
  2. Regulatory Authorization (ARCSA): Focuses on the technical safety of the device, manufacturing quality, and import logistics.6

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2.2 Key Regulations

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  • Constitution of Ecuador (Art. 66): Prohibits experimentation without informed consent.
  • Organic Health Law (Art. 208): Mandates that all health research requires prior authorization.
  • Acuerdo Ministerial 0069-2024: The operational regulation for clinical trials.3

3. Technical Prerequisites for Medical Devices

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Before submission, the device's technical file must meet international standards.

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3.1 ISO 14971 (Risk Management)

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Sponsors must submit a Risk Management File compliant with ISO 14971. This document must demonstrate that all potential hazards (electrical, thermal, biological) have been identified and mitigated to an acceptable level (ALARP) through design controls.8

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3.2 ISO 13485 (Quality Management)

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Manufacturing must occur under a quality system. A valid ISO 13485 certificate is the gold standard. For early-stage startups without full certification, a declaration of compliance with Good Manufacturing Practices (BPM) may be accepted but triggers higher scrutiny.9

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3.3 The Traceability Mandate (CUT)

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New for 2025: All investigational devices must carry a Unique Traceability Code (CUT). This applies to the supply chain from customs entry to patient implantation. The code enables ARCSA to track specific units in the event of a recall or adverse event.2

4. Ethical Review: The Submission Dossier to CEISH

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The first critical milestone is obtaining approval from an accredited CEISH.

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4.1 Recommended Committees

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For complex medical device trials, academic committees are preferred due to their technical expertise:

  • CEISH-USFQ (Universidad San Francisco de Quito)
  • CEISH-UTE (Universidad UTE)

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4.2 Checklist: The Submission Dossier to CEISH

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The application package to the Ethics Committee must include:

  • [ ] Clinical Investigation Plan (Protocol): Must include scientific justification and statistical analysis plan.
  • [ ] Informed Consent Form (ICF): Localized to Ecuadorian Spanish (6th-grade reading level).
  • [ ] Investigator's Brochure (IB): Summary of pre-clinical testing (bench/animal).
  • [ ] Investigator CVs: Documentation of GCP training and qualifications.
  • [ ] Insurance Policy: A certificate of insurance covering trial-related injuries for all participants.10
  • [ ] Patient Recruitment Material: Scripts and flyers (must be non-coercive).
  • [ ] Budget & Contract: Transparency regarding payments to the site and investigators.

5. Regulatory Authorization: The Submission Dossier to ARCSA

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Once ethical approval is secured, the sponsor submits the technical dossier to ARCSA via the VUE/Quipux digital platform.

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5.1 Fee Structure (2025)

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  • International Sponsor Fee: ~$4,000 USD (Includes Inscription and Technical Evaluation).11
  • Timeline: 30–60 days typical review time.

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5.2 Checklist: The Submission Dossier to ARCSA

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Similar to the CEISH submission, ARCSA requires a specific set of "Essential Documents" (referenced in Annex 2 of Ministerial Agreement 0069-2024).

  • [ ] Solicitud de Autorización: Formal application signed by the Local Legal Representative.
  • [ ] CEISH Approval Resolution: The official letter of approval from the Ethics Committee (Must be unconditional).
  • [ ] Proof of Payment: Receipt for the international sponsor fee (~$4,000).
  • [ ] Clinical Protocol: The exact version stamped/approved by the CEISH.
  • [ ] Investigator's Brochure (Manual del Investigador): Must include ISO 10993 biocompatibility reports and sterilization validation (if applicable).12
  • [ ] Quality Certificates: ISO 13485 certificate for the manufacturing facility.
  • [ ] Risk Analysis Report: A summary report compliant with ISO 14971.
  • [ ] Traceability Plan: A document detailing how the Unique Traceability Code (CUT) will be implemented and tracked for investigational units.2
  • [ ] Labeling Drafts: Proposed labels clearly marked: "Muestra Sin Valor Comercial - Para Investigación Clínica".
  • [ ] Legal Appointments: Notarized appointment of the Legal Representative domiciled in Ecuador.13

6. Logistics and Safety Reporting

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6.1 Importation

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  • Permits: An Import Permit is required after ARCSA trial authorization.
  • Customs: Devices must be labeled as "Samples" to avoid commercial taxes.
  • Logistics: Courier selection is critical; they must understand "Cold Chain" (if applicable) and the new Traceability tracking requirements.

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6.2 Safety Reporting (Technovigilance)

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Sponsors must report Serious Adverse Events (SAEs) to ARCSA within 24 hours.

  • Global Rule: You must report serious unexpected adverse reactions occurring outside Ecuador if they are related to the device being tested.13

7. FAQ: Clinical Trials in Ecuador

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Q: Can I submit to ARCSA and CEISH simultaneously?

A: No. The process is sequential. You must have the CEISH approval letter before you can upload your dossier to ARCSA.7

Q: Do I need a local office in Ecuador?

A: You do not need a full physical office, but you must appoint a Legal Representative domiciled in Ecuador. This person bears the legal liability for the trial before the local authorities.13

Q: How long does the entire approval process take?

A: typically 3–4 months total (1–2 months for CEISH, 1–2 months for ARCSA), assuming the dossier is complete and high quality.

Q: Is data from Ecuador accepted by the FDA?

A: Yes, provided the study is conducted under Good Clinical Practices (GCP) and the data integrity is verifiable. The FDA accepts foreign clinical data (OUS Data) to support IDE and Marketing applications.4

Appendix: 2025 Fee Schedule Reference

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Category

Fee (USD)

Inscription & Review (Intl. Sponsor)

$1,670.65

Technical Evaluation (Intl. Sponsor)

$2,272.10

Total Official Cost

$3,942.75

Source: ARCSA Official Fee Schedule 11

Works cited

  1. Ecuador presented new regulations on clinical trials developed with technical assistance from PAHO, accessed November 23, 2025, https://www.paho.org/en/news/3-2-2025-ecuador-presented-new-regulations-clinical-trials-developed-technical-assistance-paho
  2. Pharmaceutical Regulations for Ecuador | DSCSA & Global Compliance - LSPedia, accessed November 23, 2025, https://www.lspedia.com/regulation/ecuador
  3. INFORME DE ESTATUS – OPS MÓDULO 8 FISCALIZACIÓN DE ENSAYOS CLÍNICOS, accessed November 23, 2025, https://esacc.corteconstitucional.gob.ec/storage/api/v1/10_DWL_FL/e2NhcnBldGE6J2VzY3JpdG8nLCB1dWlkOic3NTJmZDU2YS1jYjRlLTQzYWEtYTA1ZC05MDRhYTdlZTBlYTIucGRmJ30=
  4. bioaccessla.com, accessed November 23, 2025, https://www.bioaccessla.com/
  5. MSP presentó normativa para regular ensayos clínicos en Ecuador, accessed November 23, 2025, https://www.salud.gob.ec/msp-presento-normativa-para-regular-ensayos-clinicos-en-ecuador/
  6. Ecuador. MSP presentó normativa para regular ensayos clínicos en Ecuador - Salud y Fármacos, accessed November 23, 2025, https://www.saludyfarmacos.org/lang/es/boletin-farmacos/boletines/may202506/23_ec
  7. Ecuador - Standards for Trade - International Trade Administration, accessed November 23, 2025, https://www.trade.gov/country-commercial-guides/ecuador-standards-trade
  8. Ecuador Regulatory Requirements - qreg.co.uk, accessed November 23, 2025, https://qreg.co.uk/ecuador-regulatory-requirements/
  9. RESOLUCIÓN ARCSA-DE-2025-XXX-DASP LA DIRECCIÓN EJECUTIVA DE LA AGENCIA NACIONAL DE REGULACIÓN, CONTROL Y VIGILANCIA SANITARIA - Comunidad Andina, accessed November 23, 2025, http://extranet.comunidadandina.org/sirt/sirtDocumentos/ECOTC25027.PDF
  10. REGLAMENTO DESARROLLO, VIGILANCIA Y CONTROL DE LOS ENSAYOS CLINICOS - Ministerio de Salud Pública, accessed November 23, 2025, https://www.salud.gob.ec/wp-content/uploads/2022/09/A.M.-0075-REGLAMENTO-ENSAYOS-CLINICOS-1.pdf
  11. Aprobación de ensayos clínicos - ARCSA, accessed November 23, 2025, https://www.controlsanitario.gob.ec/ensayos-clinicos/
  12. Ecuador Medical Device Registration | OMC Medical Limited, accessed November 23, 2025, https://omcmedical.com/ecuador-medical-device-registrations/
  13. New technical and regulatory standards for the control, registration and surveillance of medicines, biological products and clinical trials - CorralRosales, accessed November 23, 2025, https://corralrosales.com/en/new-technical-and-regulatory-standards-for-the-control-registration-and-surveillance-of-medicines-biological-products-and-clinical-trials/

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Author: Bioaccess Content Team