Which Latin American Countries Allow Early Feasibility Medical Device Trials Without GLP Preclinical Data, Full GMP Compliance, or Validated Sterility?

A country-by-country guide to GLP, GMP, and sterility requirements for early feasibility medical device trials in Latin America — based on bioaccess®'s direct operational experience.

March 27, 2026

12

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

early feasibility

GLP

GMP

ISO 13485

sterility

medical devices

Latin America

Brazil

Panama

El Salvador

clinical trials

regulatory flexibility

**Key Takeaways**

• • Brazil, Panama, and El Salvador all accept R&D-grade (non-GLP) preclinical data for early feasibility device studies
• • No ISO 13485 certification is required for investigational devices in these jurisdictions — fitness-for-use documentation is sufficient
• • Verified sterility (batch-level testing) is accepted in lieu of fully validated sterilization processes
• • Site and ethics committee selection are often more decisive than country-level regulatory strategy
• • Colombia's INVIMA pathway is slower and less predictable for novel devices without predicates

**Who Is This For?**

This guide is for medical device CEOs, VP Clinical/Regulatory Affairs, and RA/QA leaders at startups developing novel Class III devices — particularly those with neurosurgical implants, novel biomaterials, or breakthrough technologies that are not yet at commercial-grade maturity but need early clinical safety and feasibility data to advance toward FDA IDE submission.

The Early Feasibility Question Every Device Startup Asks

Medical device startups developing novel, high-risk technologies — Class III devices, neurosurgical implants, novel biomaterials, implantable neural interfaces — face a critical question when planning early feasibility studies: which jurisdictions will authorize a limited clinical trial when the device and supporting data are not yet at commercial-grade maturity?

In the United States, FDA's Early Feasibility Study (EFS) pathway, established by the 2013 guidance document "Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies," explicitly allows clinical trials before final design freeze. The EFS pathway acknowledges that early-stage devices may have limited preclinical data, evolving manufacturing processes, and sterilization methods that are not yet fully validated.

But what about Latin America? Can you run an early feasibility study in the region when your preclinical data is R&D-grade rather than GLP-compliant, your device is manufactured under a structured process rather than a fully certified ISO 13485 quality management system, and your sterilization is verified at the batch level rather than validated to commercial standards?

This guide answers these three questions based on bioaccess®'s direct operational experience conducting early feasibility and first-in-human medical device trials across Latin America — including novel neurotechnology FIH studies involving implantable devices.

Section 1: Can I Run an Early Feasibility Trial with R&D-Grade (Non-GLP) Preclinical Data?

The distinction between R&D-grade and GLP-compliant preclinical studies is fundamental. GLP (Good Laboratory Practice, codified in 21 CFR Part 58) mandates strict protocols: fully validated test methods, quality assurance unit oversight, raw data archiving, facility inspections, and auditable documentation chains. GLP studies are expensive ($200K–$500K+ for a comprehensive biocompatibility package) and time-consuming (6–12 months).

R&D-grade preclinical studies generate scientifically valid data — biocompatibility assessments (ISO 10993 series), mechanical performance testing, degradation kinetics, safety margin calculations — but without the full GLP compliance infrastructure. The data is real and meaningful, but it isn't wrapped in the administrative framework that 21 CFR Part 58 requires.

The critical insight for early feasibility in Latin America: most LATAM early feasibility pathways are ethics-committee-driven, not national-authority-driven. This means the decision-maker is an institutional ethics committee (CEP in Brazil, Comité de Bioética in Panama) evaluating whether the risk-benefit profile justifies exposing a small number of patients to an investigational device — not a national regulatory agency applying a standardized checklist of GLP requirements.

**Key Principle**

Ethics committees and regulators in the recommended early feasibility jurisdictions want a coherent risk-benefit narrative and a clear plan for which studies will later be repeated under GLP for FDA submission — not GLP certification itself. The question is: "Is this device safe enough for a controlled feasibility study in 5–10 patients with informed consent and close monitoring?" — not "Has every preclinical test been conducted under 21 CFR Part 58?"

Brazil: CEP-Only Pathway Under Law 14.874/24 and RDC 837/2023

Brazil's clinical trial landscape was transformed by Law 14.874/24 (May 2024) and RDC 837/2023, which eliminated the double-approval system (CONEP + CEP) for most studies and capped ethics reviews at 30 business days. For early feasibility studies not intended for local market clearance, only CEP (institutional ethics committee) approval is required — ANVISA national-level approval is not needed.

This is significant because CEP committees evaluate the scientific merit and risk-benefit profile of the proposed investigation, the adequacy of informed consent procedures, and the investigators' qualifications — but they do not apply a rigid GLP checklist to the preclinical dossier. R&D-grade preclinical data that demonstrates the device is fit-for-use in a controlled clinical setting is accepted.

Brazil accepts non-GLP R&D-grade preclinical data for early feasibility investigations. The emphasis is on the quality and relevance of the data, not its GLP certification status. A critical operational note: the specific institutional CEP cannot be determined until the research site and investigator are selected — making site selection a prerequisite for regulatory strategy.

Panama: EC-Driven Pathway with Direct FIH Experience

Panama offers a streamlined, ethics-committee-driven pathway for early feasibility and first-in-human device studies. bioaccess® has direct operational experience with novel neurotechnology FIH trials in Panama — including the Axoft brain-computer interface case, which involved a first-in-human implantation of a novel neural interface device.

Panama's regulatory framework for investigational devices relies primarily on the Comité Nacional de Bioética de Investigación (CNBI) and institutional ethics committees. For early feasibility studies, the pathway is EC-driven with 3–5 week approval timelines. R&D-grade preclinical data is accepted when supported by a clear risk management file (ISO 14971) and an investigator's brochure documenting all available safety information.

Panama's bilingual population (Spanish/English), strategic geographic location, and relatively small but efficient clinical research ecosystem make it particularly attractive for first-in-human device studies where speed-to-first-patient is critical.

El Salvador: Flexible EC-Driven Pathway

El Salvador provides a flexible, ethics-committee-driven pathway for early feasibility medical device studies. The regulatory environment is accommodating for novel investigational devices, with approval timelines of 3–5 months from submission to first patient enrollment.

Like Brazil and Panama, El Salvador's early feasibility pathway does not require GLP-compliant preclinical data. Ethics committees evaluate the totality of the preclinical evidence — biocompatibility, mechanical performance, safety margins — within the context of the proposed study's risk-benefit profile and the specific patient population.

Colombia: INVIMA — Slower and Less Predictable for Novel Devices

Colombia routes novel high-risk medical device investigations through INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), the national regulatory authority. Unlike Brazil, Panama, and El Salvador, where early feasibility studies are primarily ethics-committee-driven, Colombia's pathway requires national-authority review for novel devices — particularly those without predicate devices or established clinical literature.

INVIMA's review process for truly novel devices can take 8–14 months and involves unpredictable technical questions. While INVIMA is a Level 4 regulatory authority and an excellent pathway for larger, more mature clinical programs, it is generally not the optimal choice for early feasibility studies where speed-to-first-patient and regulatory flexibility are the primary considerations.

**Colombia: Best for Later-Stage Studies**

Colombia's INVIMA pathway is strong for pivotal and post-market studies, and for devices with established clinical literature. For early feasibility studies of truly novel devices, the timeline and unpredictability of INVIMA review make Brazil, Panama, or El Salvador preferable first choices. INVIMA categorizes novel device early feasibility requirements on a case-by-case basis.

Section 2: Can I Run an Early Feasibility Trial with a Device Not Manufactured Under Full GMP/ISO 13485?

The distinction here is between a fully validated production line operating under a certified ISO 13485 quality management system — with validated processes, statistical process controls, environmental monitoring, and third-party audits — and a structured manufacturing process that produces devices verified as fit-for-use in a controlled investigational setting.

For early-stage device companies, achieving ISO 13485 certification before conducting initial feasibility testing is often impractical and, arguably, premature. The whole point of an early feasibility study is to generate clinical data that informs design iteration — requiring commercial-grade manufacturing certification before that feedback loop begins defeats the purpose.

None of the recommended early feasibility countries (Brazil, Panama, El Salvador) explicitly require ISO 13485 certification for investigational devices used in early feasibility studies.

What regulators and ethics committees DO expect:

• Structured design and risk-management process: Evidence that the device was designed with appropriate risk controls (ISO 14971), even if the full design control process per ISO 13485 is not yet complete.
• Lot traceability: Ability to trace each investigational unit back to its component materials, manufacturing date, and any process deviations — basic device history record (DHR) documentation.
• Functional verification: Test data demonstrating that each device lot meets its critical performance specifications before release for clinical use.
• Basic safety checks: Electrical safety (IEC 60601 where applicable), biocompatibility confirmation, and packaging integrity verification.
• Investigator's brochure: A comprehensive document summarizing device description, manufacturing process, preclinical data, risk analysis, and instructions for use — formatted for clinical investigator review.

The standard is fitness-for-use documentation, not commercial-grade QMS certification. The device must be demonstrably safe for use in a controlled clinical setting with close monitoring — but it does not need to be manufactured on a production line that could pass a notified body audit.

Section 3: Can I Run an Early Feasibility Trial with Verified (Not Validated) Sterility?

This question is particularly critical for high-risk indications — neurosurgery, intracranial implants, cardiovascular implants, spinal devices — where the consequences of a sterility failure are catastrophic. The distinction between verified and validated sterility is important:

• Validated sterility: A fully characterized, statistically validated sterilization process (per ISO 11137 for radiation sterilization, ISO 11135 for ethylene oxide, ISO 17665 for moist heat) with routine process controls, bioburden monitoring, and documented sterility assurance levels (SAL of 10⁻⁶). This is the commercial standard.
• Verified sterility: Each batch or lot undergoes direct sterility testing (e.g., USP <71> sterility test, or ISO 11737-2 for sterility testing of medical devices) to confirm the absence of viable microorganisms. The sterilization process is well-characterized but not yet fully validated to the statistical standards required for commercial production.

Regulations in Brazil, Panama, and El Salvador do not require fully validated commercial-grade sterilization for early feasibility investigational devices. What IS required:

• Well-characterized sterilization process: Documentation of the sterilization method (EO, gamma, e-beam, steam), process parameters, and rationale for the chosen method.
• Batch-level sterility testing/verification: Direct sterility testing of each lot or batch used in the clinical investigation, with results documented in the device release records.
• Robust packaging integrity data: Evidence that the sterile barrier system maintains device sterility through storage and transport to the clinical site.
• Endotoxin testing: For implantable devices, bacterial endotoxin testing (LAL or rFC) per USP <85> or ISO 11737-1 to confirm pyrogenicity limits are met.

**Hospital Infection Control Is Often the Gatekeeper**

For high-risk implantable devices — particularly those used in neurosurgery or cardiovascular procedures — the hospital's infection control committee and the ethics committee are often more decisive than the national regulatory authority on sterility requirements. An experienced clinical site with a sophisticated infection control team will scrutinize your sterilization documentation carefully, regardless of what the national regulations technically require. This is another reason why site selection comes before country selection for early feasibility studies.

Section 4: Why Site Selection Comes Before Country Selection

One of the most common mistakes device startups make when planning early feasibility studies in Latin America is starting with the question: "Which country should we go to?" The more productive question is: "Which hospital, investigator, and ethics committee give us the best combination of clinical expertise, regulatory predictability, and operational efficiency?"

For early feasibility studies — particularly those involving novel, high-risk technologies — the specific hospital and ethics committee are often more decisive than the national regulatory framework. Here's why:

• Ethics committee quality varies: Even within a single country, different institutional ethics committees have vastly different levels of experience with novel medical devices, different review timelines, and different appetites for risk.
• Investigator expertise matters enormously: An early feasibility study of a novel neurosurgical implant needs a surgeon with specific subspecialty expertise, ideally with training at a US or European center of excellence, and experience as a clinical investigator under GCP.
• Hospital infrastructure determines feasibility: Does the hospital have the imaging capabilities, monitoring equipment, ICU backup, and post-operative care infrastructure required by your protocol?
• Infection control committees are local: The hospital's infection control team — not the national regulator — will ultimately decide whether your sterilization documentation is adequate for a high-risk implant procedure.

bioaccess® uses a proprietary 10-step site search and selection process that evaluates surgical volume, investigator qualifications (including US/UK/EU training), GCP infrastructure, and institutional ethics committee track record. The process identifies the right site first, then aligns the regulatory and ethics committee strategy around that specific combination.

For a detailed example of how this works in practice — including ethics committee requirements for a brain study involving bio-resorbable materials — see our guide on ethics committee requirements for brain studies in Brazil.

Section 5: Country Comparison Summary

The following table summarizes the regulatory flexibility for early feasibility medical device studies across the four countries where bioaccess® has operational experience:

**Important Note**

These assessments are based on bioaccess®'s direct operational experience as of March 2026. Regulatory environments evolve, and specific requirements may vary based on device risk class, indication, and the specific ethics committee reviewing the application. Contact bioaccess® for a current assessment of your specific device and intended study.

Frequently Asked Questions

JM

Julio G. Martinez-Clark

CEO & Founder, bioaccess® · 15+ years leading clinical trials and device registrations across Latin America · Former FDA regulatory affairs consultant · Has personally overseen 50+ early feasibility and first-in-human medical device studies in the region, including novel neurotechnology implants.

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Latin America offers viable, operationally proven pathways for early feasibility medical device studies that accommodate the realities of early-stage device development — R&D-grade preclinical data, devices manufactured under structured but non-certified processes, and verified sterilization at the batch level.

bioaccess® has direct operational experience running these studies, including novel neurotechnology first-in-human trials involving implantable neural interface devices. Our FIH-12™ methodology and proprietary site search process are designed specifically for the unique challenges of early feasibility device development.

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Related resources:

• Early Feasibility Studies (EFS) for Medical Devices in Latin America — /early-feasibility-studies
• First-in-Human Clinical Trial CRO — /first-in-human-cro
• Clinical Trial Cost Calculator — /clinical-trial-calculator
• Site Search & Selection Process — /site-search-selection