Chile clinical trial regulatory guide

Regulator: ISP (Instituto de Salud Pública de Chile)

Chile offers a stable regulatory environment with ISP (known internationally as ISPCH) providing clear, predictable approval pathways. The country's strong healthcare infrastructure, political stability, and experienced clinical research community make it an attractive option for medical device and pharmaceutical trials.

Approval process

1. Ethics Committee Approval. Submit to an accredited Scientific Ethics Committee (CEC). Chile has both institutional and regional ethics committees. Approval is a study-specific timeline (we confirm it per protocol) (legal limit: 45 days (Decreto 114/2010, art. 18, https://www.bcn.cl/leychile/navegar?idNorma=1032919), extendable once by 20; DS 114/2010, Art. 18 No. 2).
2. ISP Authorization. Submit clinical trial application to ISP including protocol, device dossier, ethics approval, and insurance documentation.
3. Import Authorization. Obtain import permit through Chilean customs with ISP authorization.
4. Site Activation. Complete site agreements and investigator training.

Ethics requirements

• Accredited Scientific Ethics Committee (CEC) approval required
• Informed consent in Spanish per Law 20.120
• Participant insurance mandatory
• Annual continuing review
• Special protections for vulnerable populations

Documentation requirements

• Clinical trial protocol in Spanish
• Investigator brochure
• Device technical dossier
• GMP/ISO 13485 certificates
• Insurance documentation
• Investigator qualifications and GCP training

Device registration

ISP follows a risk-based classification system similar to EU MDR. Registration requires a local authorized representative and complete technical documentation. Timelines vary by study (we confirm it per protocol). Chile's MDSAP participation can facilitate the process.

FDA acceptance of Chile data

FDA accepts Chilean clinical data under 21 CFR 812.28. Chile's regulatory standards are among the highest in LATAM, and data generated at Chilean sites is well-regarded by international regulatory bodies including the FDA and EMA.

Key contacts

• ISP (ISPCH) — Public Health Institute of Chile

Frequently asked questions

Is Chile suitable for FIH studies?

Yes. Chile is one of the countries bioaccess® leads with for a medical device clinical trial: Panama, El Salvador, Chile, Costa Rica, the Dominican Republic, and Colombia. bioaccess® runs first-in-human studies in Colombia now, devices included.

Does ISP participate in MDSAP?

Yes, Chile is an affiliate member of the MDSAP program.

What are Chile's key advantages?

Political stability, experienced investigators, strong IP protections, and predictable regulatory timelines.

How does Chile compare to Argentina?

Chile generally offers faster, more predictable timelines and avoids Argentina's provincial approval complexities.

Can Chilean data support FDA submissions?

Yes, FDA accepts Chilean clinical data when studies follow ICH-GCP and ISO 14155.

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