Ecuador clinical trial regulatory guide

Regulator: ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria)

Ecuador is developing its clinical research capacity with ARCSA modernizing regulatory processes. The country's dollarized economy (like Panama) eliminates currency risk. While not yet a primary FIH destination, Ecuador offers growing potential for multi-country LATAM trial programs.

Approval process

1. Ethics Committee Approval. Submit to an accredited Research Ethics Committee (CEI).
2. ARCSA Authorization. Submit clinical trial application to ARCSA with full documentation package.
3. Import Authorization. Obtain import permit for investigational devices.
4. Site Activation. Finalize site agreements and begin enrollment.

Ethics requirements

• Accredited Research Ethics Committee (CEI) review required
• Informed consent in Spanish
• Participant insurance mandatory
• Continuing review required

Documentation requirements

• Clinical trial protocol in Spanish
• Investigator brochure
• Device technical file
• GMP/ISO 13485 certificates
• Insurance documentation

Device registration

ARCSA manages device registration with a risk-based classification system. Ecuador's dollarized economy and growing healthcare infrastructure make it an emerging option for device registration. Timelines vary by study (we confirm it per protocol).

FDA acceptance of Ecuador data

FDA accepts Ecuadorian clinical data under 21 CFR 812.28 when studies follow ICH-GCP. Ecuador's dollarized economy and growing research infrastructure make it a viable option for generating FDA-submissible data.

Key contacts

• ARCSA — National Health Regulatory Agency

Frequently asked questions

Is Ecuador ready for FIH trials?

Ecuador is developing capacity. It's better suited as part of multi-country LATAM programs rather than standalone FIH.

Does Ecuador use the US Dollar?

Yes, Ecuador's dollarized economy eliminates currency risk, similar to Panama.

How is ARCSA modernizing?

ARCSA is implementing digital submission systems and aligning processes with international standards.

Can Ecuadorian data support FDA submissions?

Yes, when studies follow ICH-GCP and ISO 14155 standards.

What are the cost advantages?

Ecuador offers some of the lowest clinical trial costs in LATAM, below US rates.

All Latin America regulatory guides · Book a free 30-min strategy call