Category: Advantages of Conducting Trials in Latin America

Short answer: It depends on three things: what you claim the patch does, how far the needles are designed to go into the skin, and whether a drug or biologic is part of the product. Under guidance from the US Food and Drug Administration (FDA), a microneedle product that claims or is designed to penetrate past the stratum corneum into living skin generally meets the device definition. Once a drug or biologic is coated on, loaded into or packaged with the patch, it may be a combination product, and FDA decides which center leads. The registered-cosmetic route fits only a product that stays on the skin surface and makes appearance claims. The cosmetic definitions in Central America, Panama and Chile are all written around superficial or external application. Settle the category before you write the protocol for your first-in-human (FIH) study, because it decides which dossier the ethics committee and health authority will expect.

Why the category question comes first

Microneedle patches sit on three regulatory borders at once: device and drug, device and biologic, and device and cosmetic. For a startup, the category drives almost everything that follows: which FDA center reviews the product, which investigational application applies in the US, what manufacturing evidence an ethics committee asks for, and whether a polymer-only version and a later drug-loaded version can be treated as the same product.

The rest of this post walks through the US framework first, because most sponsors plan to use FIH data from Latin America in an FDA submission. It then covers the cosmetic and device definitions in Central America, Panama and Chile.

How FDA draws the device line for microneedling products

FDA’s guidance Regulatory Considerations for Microneedling Products (FDA guidance page; PDF) is the clearest US statement. It defines the stratum corneum as “a dead cell layer of skin, as opposed to living layers of skin.” It then says FDA considers claims or statements “that indicate penetration or some effect beyond the stratum corneum into living layers of skin” to be evidence of intent to affect the structure or function of the body. That intent is what makes a product a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Claims are not the only test. The same guidance says FDA considers “needle penetration beyond the stratum corneum as a result of the design or technology” of a product as evidence that it may be a device. FDA lists what it may look at: needle length and arrangement, needle sharpness, and the degree of control over “depth of penetration into living layers of skin” (FDA microneedling guidance, section IV). In practice, your design specifications and directions for use can classify the product even if your marketing copy is careful.

The guidance also describes products that are generally not devices: microneedling products “that do not penetrate living skin” and claim only to facilitate exfoliation, improve the appearance of skin, give skin a smoother look and feel, or give skin a luminous look. FDA adds that such products “may still be subject to other requirements of the FD&C Act” (FDA microneedling guidance, section V).

For devices, aesthetic microneedling is classified at 21 CFR 878.4430 (Code of Federal Regulations, CFR) as Class II with special controls. The identification text matters for patch developers: it “does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.” A patch built to deliver an active ingredient is therefore outside that classification by its own terms.

When a drug-loaded patch becomes a combination product

FDA’s microneedling guidance excludes products used with topically applied substances such as “creams, ointments, gels, vitamin solutions, drugs, or blood products.” It says these “may be combination products under 21 CFR 3.2(e)”, that they are “outside the scope of this guidance”, and that manufacturers should contact the Office of Combination Products (OCP) (FDA microneedling guidance, section III).

The definition at 21 CFR 3.2(e) covers several configurations that map onto patch programs:

• Single entity. Two or more regulated components “physically, chemically, or otherwise combined or mixed and produced as a single entity” (3.2(e)(1)). Coated, drug-loaded or dissolving microneedles usually raise this question.
• Co-packaged. “Two or more separate products packaged together in a single package or as a unit” (3.2(e)(2)), such as a needle array sold in a kit with a serum.
• Cross-labeled. Separately packaged products whose labeling or investigational plan says they are for use only with a specified drug, device or biologic, where both are required for the intended effect (3.2(e)(3) and (4)).

FDA’s page on combination product types lists a microneedle “patch” as a common example of a prefilled drug delivery system, and a “microneedle patch pre-loaded with biological product” as an example of a prefilled biologic delivery system.

Which FDA center leads depends on the primary mode of action (PMOA). Under 21 CFR 3.2(m), the PMOA is “the single mode of action of a combination product that provides the most important therapeutic action.” Depending on the answer, the lead is the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). If the answer is unclear, 21 CFR 3.7 provides a formal request for designation (RFD) and says “a sponsor should file a request for designation before filing any application for premarket review, whether an application for marketing approval or a required investigational notice.” For an FIH plan, that means the jurisdiction question belongs before the US investigational filing, not after the first human data are in.

The “blank patch first” plan

A common development plan is to run the first human study with a polymer-only patch and add an active ingredient later. The sources above support a few cautious points:

• A polymer-only patch is assessed on its own claims and design. If its needles are designed to reach living epidermis or dermis, FDA’s guidance points toward the device definition.
• Once an active is added, the product has to be assessed again under 21 CFR 3.2(e). The loaded patch may be a different regulated product with a different lead center.
• How far data from the blank patch can support the loaded product is a question for FDA, not an assumption. Put it to the agency early, either to OCP or in a Q-Submission (Q-Sub) meeting request.

Write both versions into your regulatory plan from the start, and keep the FIH protocol’s claims about the blank patch consistent with the later program. A safety claim written loosely for the first study can complicate the classification of the second.

The registered-cosmetic route: what it covers in Latin America

Some sponsors ask whether a patch can be registered as a cosmetic and tested that way. The answer turns on the local cosmetic definition, and those definitions are narrow.

Costa Rica and El Salvador: the Central American cosmetics regulation

Central American cosmetic registration follows the Central American Technical Regulation (RTCA, Reglamento Técnico Centroamericano) RTCA 71.03.35:21, adopted by the Council of Ministers of Economic Integration (COMIECO) in Resolución No. 474-2023 (COMIECO-EX). The Secretariat for Central American Economic Integration (SIECA) lists the resolution as in force (SIECA). The resolution states that it entered into force on 5 February 2024.

Its definition (section 4.11) covers products “destinado a ser puesto en contacto con las diversas partes superficiales del cuerpo humano (epidermis, sistemas piloso y capilar, uñas, labios y órganos genitales externos)” for cleaning, perfuming, changing appearance, correcting body odor or protecting them. El Salvador published the regulation in its Diario Oficial (copy hosted by the Superintendencia de Regulación Sanitaria, SRS). Costa Rica’s Ministerio de Salud links the resolution from its cosmetic registration page.

Panama

Panama’s Ministry of Health (MINSA, Ministerio de Salud) states that Ley 419 of 1 February 2024 replaced (“subroga”) Ley 1 of 2001, and that Executive Decree 27 of 10 May 2024 regulates it. According to the same MINSA document, Article 192 of that decree says cosmetic registration and labeling follow the RTCA for cosmetic products (MINSA, DNFD presentation, May 2024). The National Directorate of Pharmacy and Drugs (DNFD, Dirección Nacional de Farmacia y Drogas) puts the line plainly: “Los productos cosméticos solo están indicados para uso tópico. No se ingieren, inhalan o inyectan dentro del cuerpo humano.” It adds that a cosmetic attributed therapeutic properties “debe registrarse como medicamento” (DNFD explainer). The exact definition article in Ley 419 should be confirmed per study.

Chile

Chile’s cosmetics regulation, Decreto Supremo (DS) 239 of 2002 (BCN), defines a cosmetic as a preparation “que se destine a ser aplicado externamente al cuerpo humano”, with only local action or, if absorbed, “carezca de efecto sistémico”. The Instituto de Salud Pública (ISP) repeats that definition in its technical guide on borderline medical devices (Guía Técnica sobre Dispositivos Médicos Frontera, October 2022). The same guide sets the device condition that the product does not achieve “su acción principal en o sobre el cuerpo humano por mecanismos farmacológicos, inmunológicos o metabólicos.” Where a sponsor is unsure, the guide says to seek a ruling (“pronunciamiento”) from the ISP’s Comité de Régimen de Control Sanitario. See also the ISP cosmetics page.

What this means for a patch

A patch whose needles are designed to reach living tissue, or that delivers an active for a therapeutic or structure-or-function effect, is hard to fit inside any of these definitions. Cosmetic registration is a marketing authorization for a cosmetic. It does not authorize a clinical investigation of a device, drug or combination product, and it will not help an FDA submission that depends on device or drug data. Whether consumer-use or claims testing of a genuinely cosmetic product needs ethics review differs by country and should be confirmed per study.

How the category changes your FIH study

Category	US anchor	What it means for an FIH study in Latin America
Device (no active)	FDA device test (FD&C Act 201(h)); foreign data under 21 CFR 812.28	Run as a device clinical investigation. In Costa Rica the device category is “equipo y material biomédico” (EMB) under Reglamento 39061-S as amended by Decree 44033-S (La Gaceta, Alcance 111, 2023). In Chile, ISP special authorization applies to trials of a “producto farmacéutico o dispositivo médico” (Código Sanitario, Art. 111 A).
Combination product	21 CFR 3.2(e); PMOA; RFD under 21 CFR 3.7	Confirm per study which pathway (drug or device) each health authority and ethics committee will apply, and expect questions on both the drug and the device constituents.
Cosmetic	Not a device if it does not penetrate living skin and makes appearance-only claims (FDA guidance, section V)	Registration under RTCA 71.03.35:21, Panama’s Ley 419 framework or Chile’s DS 239. Not a substitute for a clinical trial authorization.

Practical steps before you write the protocol

1. Write down the intended use and every claim you plan to make, including in the consent form and instructions for use.
2. Document the design facts FDA says it may weigh: needle length, arrangement, sharpness and control of penetration depth.
3. If any active ingredient is involved, map the product against 21 CFR 3.2(e), state your PMOA reasoning and decide whether to contact OCP or file an RFD before any US investigational filing.
4. Ask FDA how it will view FIH data generated in Latin America. For a device study, plan to meet 21 CFR 812.28.
5. Check the category in each target country. In Chile, the ISP categorization route is in the borderline-device guide; elsewhere, confirm per study with the health authority.
6. Keep the category consistent across protocol, investigator brochure, labeling and consent. Ethics committees notice when documents describe the product differently.

Where bioaccess® fits

bioaccess® runs first-in-human and early feasibility medical device studies in Latin America. For borderline products such as microneedle patches, we work through the category question country by country with the sponsor’s regulatory team before anything is submitted, so the protocol, the ethics dossier and the later FDA plan tell the same story.

Related reading

• Running a First-in-Human Dermatology or Aesthetic Device Trial in Latin America: Sites, PIs and Outpatient Clinics
• Healthy Volunteers in Device FIH Studies: What Ethics Committees Allow on Compensation in Costa Rica, El Salvador, Panama and Chile
• 10 Startup Mistakes That Delay a Latin America FIH Study (and How to Avoid Them)
• Medical device combination products: a tutorial on regulations and compliance
• FDA Q-Submission: what to send before your IDE filing
• FDA foreign clinical data and 21 CFR 812.28 for Latin America studies
• Early feasibility vs pivotal trial
• Preclinical testing before a device FIH study in Latin America
• Fitzpatrick skin type diversity in clinical trials

FAQ

Is a microneedle patch a medical device?

Often, but not always. FDA guidance treats claims or design features that indicate penetration beyond the stratum corneum into living layers of skin as evidence that a microneedling product is a device. A product that does not penetrate living skin and makes only appearance or exfoliation claims would generally not be a device.

When does a microneedle patch become a combination product?

When a drug or biologic is combined with it as a single entity, packaged with it, or cross-labeled for use only with it, as described in 21 CFR 3.2(e). FDA lists a microneedle patch as a common example of a prefilled drug delivery system and of a prefilled biologic delivery system.

Who decides which FDA center reviews a drug-loaded patch?

FDA assigns the lead center based on the primary mode of action. If the answer is unclear, a sponsor can file a request for designation under 21 CFR 3.7, which says the request should be filed before any premarket application or required investigational notice.

Can a microneedle patch be registered as a cosmetic in Central America, Panama or Chile?

Only if it genuinely fits the cosmetic definition. RTCA 71.03.35:21 covers products in contact with superficial parts of the body, Panama’s DNFD says cosmetics are not injected into the body, and Chile’s DS 239 covers products applied externally. A patch designed to reach living tissue or deliver an active is hard to fit inside these definitions.

Does cosmetic registration let me run a clinical study of my patch?

No. Cosmetic registration is a marketing authorization for a cosmetic. A clinical investigation of a device, drug or combination product needs ethics committee approval and, where required, health authority authorization in each country. Whether claims testing of a true cosmetic needs ethics review should be confirmed per study.

Can I run my first study with a polymer-only patch and add the drug later?

Many teams plan it that way, but the loaded patch has to be assessed again as a possible combination product. How far data from the blank patch can support the loaded product is a question to put to FDA early, through the Office of Combination Products or a Q-Submission.

Short answer: The rules do not ask for “a doctor”. They ask for an investigator qualified by education, training and experience, and Chile’s device guide adds experience in the device’s field of application. Costa Rica’s regulation goes further: a device study must run under a principal investigator suited to the product. For devices used on the skin and soft tissue, that field of application is the daily work of dermatologists and plastic surgeons. That is why they are often the strongest choice of principal investigator for aesthetic and dermatology device first-in-human (FIH) trials, provided their site, credentials and time also meet the local rules.

bioaccess® is a contract research organization (CRO) that runs FIH and early feasibility medical device studies in Latin America. We identify and qualify investigators, and the investigators conduct the clinical work at their sites. This article explains what the regulations ask of an investigator, why these two specialties fit, and what to check before you choose one.

What the rules ask of an investigator

Source	What it requires
International Council for Harmonisation (ICH), E6(R3) Good Clinical Practice (GCP) guideline, sections 2.1–2.2	Investigators “should be qualified by education, training and experience to assume responsibility for the proper conduct of the trial” and provide evidence of it (2.1.1). They should be familiar with the investigational product (2.1.2), able to show they can recruit the agreed number of eligible participants (2.2.1), and have enough time, qualified staff and facilities (2.2.2).
Chile, Instituto de Salud Pública (ISP), device clinical investigation guide (Resolución Exenta 2.050 of 2026), section 10.2	The responsible investigator must have the academic qualification, training and experience to run the investigation, “tener experiencia en el campo de aplicación y poseer formación en la utilización del DM” (DM is dispositivo médico, medical device; experience in the field of application and training in use of the device), disclose conflicts of interest, and know how informed consent is obtained.
Costa Rica, Reglamento 39061-S as amended in 2023, Art. 72(c)	Device studies must be carried out “bajo la responsabilidad de un profesional acorde al producto a investigar; como investigador principal” (under the responsibility of a professional suited to the product, as principal investigator).
Costa Rica, Ley 9234, Art. 51	The investigator must have the academic training, practical training and experience to conduct the research (d), make sure the team is suitably qualified (f), and be fully familiar with the protocol, consent, investigator’s brochure and the investigational device (h).
US, Code of Federal Regulations (CFR), 21 CFR 812.43 (relevant if the data will support a US Food and Drug Administration filing)	“A sponsor shall select investigators qualified by training and experience to investigate the device.” The signed investigator agreement includes the curriculum vitae (CV) and, where applicable, a statement of relevant experience.

ICH E6(R3) is written for drugs and biological products. For device trials, El Salvador’s Superintendencia de Regulación Sanitaria (SRS) applies ISO 14155, the International Organization for Standardization (ISO) GCP standard for devices (SRS clinical-trial guide, section 5), and Chile’s ISP guide refers to the Chilean adoption of ISO 14155. Panama’s Decreto Ejecutivo (DE) 21 of 2026 lists ICH GCP among the reference documents for ethics review (Art. 71).

Why these two specialties fit aesthetic and dermatology devices

1. They already work in the field of application

Chile’s guide asks for experience in the device’s field of application, and Costa Rica’s asks for a principal investigator (PI) suited to the product. When a device acts on the skin, scars, wounds or subcutaneous tissue, the specialists who diagnose and treat those tissues every day meet that test directly. A PI from another specialty can still qualify, but the ethics committee will expect the CV to show why.

2. Endpoint assessment is part of their routine

Many aesthetic and dermatology endpoints depend on a clinician’s assessment of the skin, often supported by standardized photography and grading scales defined in the protocol. An investigator who makes those judgments in daily practice is better placed to apply a scale the same way at every visit. Rater training is still needed, and the protocol should define it.

3. They can manage the adverse events these devices tend to cause

ICH E6(R3) places trial-related medical care and decisions with a qualified physician who is an investigator or sub-investigator (2.7.1), and Chile’s guide says medical care of participants must always be the responsibility of a qualified physician. Whatever the protocol lists as anticipated adverse events for a skin or soft-tissue device, the specialist who treats that tissue in practice is best placed to recognize, grade and manage them.

4. Device technique transfers quickly

Investigators must be trained in using the investigational device (Chile guide 10.2(b); ICH E6(R3) 2.1.2), and Chile’s guide makes the sponsor responsible for documenting that training (9.2.1(h)). A clinician who already performs comparable procedures usually has less to learn, which lets training focus on what is new about the device.

5. Their practices see the target population

The investigator should be able to show a realistic potential to recruit eligible participants (ICH E6(R3) 2.2.1). Aesthetic and dermatology practices see the people these devices are designed for. Ask for evidence, such as anonymized counts of relevant patients, rather than an estimate.

Dermatologist or plastic surgeon?

Choose by the procedure the protocol requires, not by the device label. As a rule of thumb:

• Dermatologist as PI: devices that treat skin conditions or the skin surface, where the main endpoints are dermatological assessments.
• Plastic surgeon as PI: devices that involve incision, implantation, wound closure, scar revision or reconstruction.
• Both: many aesthetic devices sit between the two. One model is a PI from one specialty with a sub-investigator from the other. Under ICH E6(R3) 2.3, the PI can delegate tasks to qualified team members but keeps overall responsibility and must keep a delegation record.

What to check before you choose

The site, not only the doctor

Aesthetic and dermatology studies may be proposed at private outpatient clinics. Each country sets its own site rules:

• Costa Rica: description of the site and facilities, valid habilitation certificates, and an emergency plan stating which centers participants go to (Reglamento 39061-S Art. 44(p), (dd), (pp)).
• Chile: research centers must be accredited by the ISP (Código Sanitario Art. 111 D). How this applies to a given clinic: confirm per study.
• El Salvador: the SRS application form asks for the research center’s SRS establishment registration number (SRS guide §6.1.1.5).
• Panama: registration on the Registro y Seguimiento de la Investigación para la Salud (RESEGIS) platform needs a no-objection from the entity where the study will run (DE 21 Art. 84(1)).
• Peru: each research center must hold a valid registration as a center authorized for clinical trials (Decreto Supremo (DS) 021-2017-SA Art. 67(b)).

Credentials and training

• Costa Rica: CV with identity document, current professional license or medical college registration, a GCP course under three years old endorsed by the Consejo Nacional de Investigación en Salud (CONIS), and CONIS investigator accreditation (Art. 44(z)–(aa); Ley 9234 Art. 43(c)).
• Panama: at least one PI resident in the country (DE 21 Art. 69), and GCP courses approved by the national bioethics committee at least every three years (Art. 67).
• El Salvador: GCP certificates for investigators, sub-investigators and coordinators, and a PI declaration of compliance with GCP and the Declaration of Helsinki (SRS guide §6.4(6), (10)).
• Peru: GCP and research ethics training no more than three years old for the whole team (Art. 67(q)).
• Chile: current CV or equivalent evidence, device training, and a conflict-of-interest disclosure (ISP guide 10.2).

Time

Specialists in private practice may work across several clinics. El Salvador’s application form asks for the PI’s current trial workload and whether they practice in other establishments (SRS guide §6.1.1.10), and ICH E6(R3) 2.2.2 asks for enough time for the full trial. Agree on protected study time and a named backup sub-investigator before you file.

Conflicts of interest

Costa Rica requires conflict-of-interest declarations from the whole team (Art. 44(cc)), and Chile’s guide requires the investigator to disclose conflicts, including financial ones (10.2(c)). Disclose consulting, equity or royalty links to the device or a competitor early.

Common mistakes

• Choosing a PI on reputation alone, without checking site authorization and GCP certificate dates
• Running the study in a clinic with no documented emergency pathway
• Naming a PI who has no protected time for visits and safety follow-up
• Leaving device training undocumented
• Choosing a specialty that does not match the procedure in the protocol

How bioaccess® works with investigators

bioaccess® is the CRO. We build the qualification questionnaire for the device, check the investigator’s and the site’s documents against each country’s rules, and support training, monitoring and filings. The investigators and their sites conduct the study and keep the responsibilities the rules assign to them. For our method, see how we qualify FIH sites and investigators in Latin America.

Related reading: Pre-study document checklist by country for device FIH studies · Good Manufacturing Practice attestation or ISO 13485 certificate? · Costa Rica FIH activation calendar · Chile ISP clinical trial approval for medical devices · Clinical trial insurance in Latin America

Frequently asked questions (FAQ)

Does a dermatology device first-in-human trial need a dermatologist as principal investigator?

No regulation reviewed here names a specialty. Chile’s ISP guide asks for experience in the device’s field of application, and Costa Rica asks for a principal investigator suited to the product. For a skin device, a dermatologist or plastic surgeon usually meets that test most directly.

What does ICH E6(R3) require of an investigator?

Section 2.1 says investigators should be qualified by education, training and experience, provide evidence of those qualifications, and be familiar with the investigational product. Section 2.2 asks them to show recruitment potential and to have enough time, staff and facilities. ICH E6(R3) is written for drugs and biological products; device trials use ISO 14155.

Can a private aesthetic clinic be a trial site?

It can if it meets the country’s site rules. Costa Rica asks for habilitation certificates and an emergency plan, Chile requires ISP accreditation of research centers, El Salvador asks for the center’s SRS registration number, and Peru requires a registered research center. Confirm per study.

How recent must an investigator’s GCP training be?

Costa Rica asks for a CONIS-endorsed GCP course under three years old. Panama requires GCP courses approved by the national bioethics committee at least every three years. Peru asks for GCP and research ethics training no more than three years old.

Is the investigator’s site the CRO?

No. The investigator and site conduct the clinical work and keep the responsibilities the rules assign to them. bioaccess® is the CRO and supports qualification, training, monitoring and regulatory filings.

Short answer: Before a medical device first-in-human (FIH) study can start in Latin America, three gates have to be cleared: the ethics committee, the health authority and, for imported devices, the import or customs-release step. The core dossier is largely the same in every country. The differences are in translations, who files, which quality documents are accepted and what each committee adds on top. This checklist sets out what the regulations of Costa Rica, Panama, El Salvador, Chile and Peru say, with the primary source next to each item. Anything we could not verify in a primary text is marked “confirm per study”.

bioaccess® is a contract research organization (CRO) that runs FIH and early feasibility medical device studies in Latin America. Sponsors, especially medtech startups, often ask us for one list they can work from before the protocol is final. This is that list, written for device studies in general. It is not legal advice, and committees can ask for more than the regulation lists.

How to read this checklist

• Ethics committee (EC): reviews the protocol, consent and investigator documents. The local names differ: Comité Ético Científico (CEC) in Costa Rica and Chile, Comité de Bioética de la Investigación (CBI) in Panama, and Comité Institucional de Ética en Investigación (CIEI) in Peru.
• Health authority: registers or authorizes the study and, in some countries, evaluates the investigational device.
• Import: clears each shipment of an unregistered investigational device. A document accepted at one gate does not automatically satisfy the next.
• “Confirm per study”: the item depends on the device, its classification, the committee or a rule we could not open in a primary source.

The core dossier: documents the sponsor prepares once

These items appear in the requirement lists of several countries. Prepare them once, then adapt them to each country’s format and language.

Document	Where the regulation names it
Clinical investigation plan (protocol), dated and versioned	Costa Rica Art. 44(b); El Salvador Superintendencia de Regulación Sanitaria (SRS) guide §6.4(2); Panama Decreto Ejecutivo (DE) 21/2026 Art. 84(3); Chile Instituto de Salud Pública (ISP) device guide §5.6.2(a); Peru Art. 67(l)
Investigator’s brochure (IB)	Costa Rica Art. 44(c); El Salvador §6.4(4); Chile §5.6.2(b); Peru Art. 67(n)
Informed consent form (ICF)	Costa Rica Art. 44(d); El Salvador §6.4(3); Chile §5.6.2(c) and Código Sanitario Art. 111 A; Peru Art. 67(m)
Case report form (CRF) and participant materials	Costa Rica Art. 44(f)–(g); Chile §5.6.2(f)
Curriculum vitae (CV) of the investigators and team	Costa Rica Art. 44(z); El Salvador §6.4(9); Chile §5.6.2(e) and (l); Peru Art. 67(p)
Good Clinical Practice (GCP) training evidence	Costa Rica Art. 44(z); El Salvador §6.4(10); Panama DE 21 Art. 67; Peru Art. 67(q)
Conflict-of-interest declarations	Costa Rica Art. 44(cc); Chile §5.6.2(i); Peru Art. 67(h)
Clinical trial agreement and budget	Costa Rica Art. 44(l)–(m); El Salvador §6.4(12); Chile §5.6.2(h); Peru Art. 67(r)
Participant insurance policy	Costa Rica Art. 44(jj)–(kk) and Ley 9234 Art. 31; El Salvador §6.4(14); Chile Código Sanitario Arts. 111 A and 111 F; Peru Art. 67(j)
Manufacturer Good Manufacturing Practice (GMP) or quality evidence	Costa Rica Art. 44(r); El Salvador §7.2(a); Peru Art. 67(o) and Annex 5. See our GMP attestation guide.
Sterility certificate for sterile devices	Costa Rica Art. 44(r); El Salvador §7.2(d)
Device technical file: description, manufacturing process, operating principles, test results (including biocompatibility), materials of human or animal origin	El Salvador §7.2(b)–(g); Costa Rica Art. 44(tt)
Risk management plan based on ISO 14971, the International Organization for Standardization (ISO) standard for device risk management	El Salvador §7.2(h)
Instructions for use and packaging or label artwork	Costa Rica Art. 44(s); El Salvador §6.4(16)
Prior regulatory status, such as a US Investigational Device Exemption (IDE) or an approval letter from another agency	Costa Rica Art. 44(h); El Salvador §6.4(17), when applicable. Confirm per study what an FIH device with no prior approval needs instead.
Public trial registration	Panama DE 21 Art. 79 (registered in a public registry that meets World Health Organization standards before the trial starts)

Sources: Costa Rica, Decreto Ejecutivo 44033-S amending Reglamento 39061-S (Alcance 111, La Gaceta 106, 14 June 2023). El Salvador, SRS clinical-trial authorization guide. Panama, Decreto Ejecutivo 21 of 23 April 2026. Chile, ISP Resolución Exenta 2.050 of 2026 and the Código Sanitario. Peru, Decreto Supremo (DS) 021-2017-SA.

Language, legalization and representation

• Costa Rica: the protocol and IB go in the original language plus an official Spanish translation (Art. 44(b)–(c)).
• El Salvador: all documents filed with the SRS must be in Spanish (SRS guide §5, item 6). The application form names the sponsor’s representative or attorney in El Salvador (§6.1.1.2).
• Panama: documents filed for registration on the Registro y Seguimiento de la Investigación para la Salud (RESEGIS) platform must be in Spanish and match the versions sent to the ethics committee (DE 21 Art. 85).
• Chile: the ISP guide tells a sponsor that does not reside in Chile to select a local representative who acts as the sponsor (ISP guide §9.2.1(b)). The consent must be in non-technical Spanish or the participant’s native language (§5.8.2(d)).
• Peru: the protocol and IB go in Spanish and the original language (Art. 67(l), (n)). A foreign sponsor files its delegation to a local representative with a Hague apostille (Art. 67(f)).
• Apostille or legalization of other foreign documents: Confirm per study and per document.

Costa Rica: CEC, national research council and customs release

Biomedical research is governed by Ley 9234 (La Gaceta 79, 25 April 2014) and its regulation, Decreto Ejecutivo 39061-S, as amended in 2023. The institution or investigator files the package with a CEC of their choice (Art. 44). The Consejo Nacional de Investigación en Salud (CONIS) accredits CECs, CROs and investigators (Ley 9234 Art. 43(b)–(c)).

CEC package (Art. 44), beyond the core dossier

• Investigator’s cover letter requesting review (a)
• Device classification under Costa Rica’s medical device regulation (i)
• List of countries and sites, and expected participants per site and in Costa Rica (k), (o)
• Description of the site, facilities and laboratories (p), plus valid habilitation certificates (dd)
• History of submissions to other Costa Rican CECs (q)
• Team CVs with identity document, current professional license or college registration, and a GCP course certificate under three years old endorsed by CONIS (z)
• Copy of CONIS accreditation of investigators and sub-investigators (aa), team compliance commitment (bb) and conflict-of-interest declarations (cc)
• Injury treatment and indemnity plans (ee); principal investigator (PI) commitments on serious adverse event reporting within 24 hours and periodic reports (ff)–(hh)
• Sponsor commitments: injury costs (ii), insurance for the investigator and team with a copy of the policy (jj), participant compensation with a policy valid at least two years after the study ends (kk), post-study treatment where beneficial (ll), reporting results (mm) and publication role (nn)
• Recruitment plan (oo), emergency plan (pp), signature log (qq) and participant-rights procedure (rr)
• Sworn declaration on whether a CRO (organización de investigación por contrato, OIC) or site management organization (organización de administración por contrato, OAC) takes part, with their CONIS accreditations (ss)
• Technical and medical specifications, inserts and user manuals (tt); sponsor commitment to bear all device-related costs (uu); care and monitoring plan for implantable devices (vv)

Device protocols must also cover items including the device type and regulatory class, novelty, nature and period of exposure, materials, inherent risks, the impact of device failure, expected service life and alternatives (Art. 73). Under Art. 72(c), the PI must be a professional suited to the product under investigation.

Ley 9234 Art. 31 requires a civil-liability policy that covers participants from the start of the study until at least two years after their participation ends, and that is enforceable in Costa Rica. The CEC decides within one calendar month (Art. 42). Whether a given FIH device study must go to a particular committee: Confirm per study.

Import and customs release (Art. 55)

• Import only after CEC approval and registration with CONIS (Art. 55(a))
• Before the first shipment, a CEC-endorsed request to CONIS listing the devices and supplies and their quantities (Art. 55(b))
• For each customs release: CONIS request form, CEC approval letter, commercial invoice or acquisition document, transport document, and a GMP certificate for each manufacturing establishment issued by the authority of the manufacturing country (Art. 55(g)(i)–(vi))

Fees and the current CONIS forms: Confirm per study. For sequencing, see our Costa Rica FIH activation calendar.

Panama: registration, ethics review and product evaluation

Decreto Ejecutivo 21 of 2026 regulates health research under Ley 84 of 2019. Every health research study must be registered with the Ministerio de Salud (MINSA) through the RESEGIS platform before the ethics committee certifies its decision (Arts. 79 and 82).

RESEGIS registration (Art. 84)

• No-objection or consent from the public or private entity where the study will run
• Registration request by the PI from an activated RESEGIS user account
• Protocol and annexes, in the same version that goes to the CBI or the national committee (Comité Nacional de Bioética de la Investigación, CNBI)

MINSA issues a registration receipt for the ethics review within three business days (Art. 86).

Ethics and investigator items

• At least one PI resident in Panama; the committees check this from the time of submission (Art. 69)
• The sponsor’s financial provisions for compensating research-related harm, attached to the documents for ethics review (Art. 67(2))
• GCP courses approved by the CNBI, at least every three years, for the investigator and team (Art. 67)
• Committee-specific forms, format and fees: Confirm per study. See our Panama CNBI procedure checklist.

Product evaluation and import

For high-risk research using “medicamentos o productos para la salud humana”, the Dirección Nacional de Farmacia y Drogas (DNFD) evaluates the product before the trial, using the protocol, GMP certificates or a qualified-person GMP declaration, a certificate of analysis and the IB (Art. 95). Import of research products is based on RESEGIS registration, ethics approval and DNFD authorization (Art. 99). The document list in Art. 95 names the investigational medicamento. How Arts. 88, 95 and 99 apply to an investigational device: Confirm per study.

El Salvador: SRS and the national ethics committee

The Superintendencia de Regulación Sanitaria (SRS) authorizes clinical trials of drugs and medical devices. Its guide applies ISO 14155 (clinical investigation of medical devices, good clinical practice) to device trials (SRS guide §5, item 6). The ethics approval minutes are one of the SRS requirements, so ethics review comes first (§6.4(1)).

SRS general requirements (§6.4), beyond the core dossier

• Authorization from the head of the public institution where the trial runs, if applicable (5)
• PI declaration of compliance with GCP, the Declaration of Helsinki and current rules (6); same declaration from sub-investigators and staff (8)
• Joint sponsor–PI declaration of economic capacity to finish the trial (7)
• Training certificate for staff who handle, store or dispense the investigational product, when they are outside the pharmacy or biomedical area (11)
• Contract between the research center and any associated centers (13)
• Insurance policy that applies in El Salvador (14)
• Appointment of the data safety monitoring committee and the schedule for its safety reports (15)
• Fee receipt (18). Amount: Confirm per study

The application form also asks for the PI’s current workload and the research center’s SRS establishment registration number (§6.1.1). The device-specific list in §7.2 is covered in the core dossier above.

The ethics committee’s own document list (Comité Nacional de Ética de la Investigación en Salud, CNEIS) and the import permit steps: Confirm per study. We did not open the current CNEIS manual for this guide.

Chile: CEC, site director and ISP

Under Ley 20.120 Art. 10, biomedical research needs the express authorization of the director of the establishment, after a favorable report from the CEC (Ley 20.120). Under Código Sanitario Art. 111 A, any device that is not registered, or is used differently from its registration, needs an ISP special authorization for provisional use for research. The filing comes after approval under Ley 20.120 Art. 10 and includes the protocol, the consent form, the insurance policy and any other document set by regulation. The authorization lasts up to one year and can be renewed. The Ministry of Health may exempt low-risk devices by decree. Whether any such exemption covers your device: Confirm per study.

CEC initial submission (ISP guide §5.6.2)

The ISP device guide approved by Resolución Exenta 2.050 of 2026 recommends, as a minimum: the protocol, the IB or equivalent, the consent form and other written participant information, recruitment procedures and materials, and the PI’s CV. Depending on the design and the committee, it may also be necessary to file the CRF, documents on payments and compensation to participants, the clinical investigation agreement and site payment, conflict-of-interest documents, evidence of insurance, the sponsor’s delegation of duties, and the CVs of other team members.

Other Chile items

• Local representative for a sponsor that does not reside in Chile (ISP guide §9.2.1(b))
• Civil-liability insurance held by the authorization holder (Código Sanitario Art. 111 F). The same article says a decree sets the device classes for which an insurance policy is mandatory. How that applies to your device: Confirm per study.
• Research centers must be accredited by the ISP under Art. 111 D. How this applies to your site today: Confirm per study.
• The ISP dossier list for the device provisional-use authorization: Confirm per study. ISP ran a public consultation on its filing guide in June and July 2026, and we have not confirmed the final version.

Related: Chile ISP clinical trial approval for medical devices and Chile ISP device vs drug trials.

Peru: CIEI approval and national authorization

DS 021-2017-SA sets the documents the sponsor or CRO files with the Instituto Nacional de Salud (INS) to authorize a trial (Art. 67). Beyond the core dossier, the list includes the registration of each research center, approval from the institution’s legal representative, CIEI approval of the protocol and consent, sworn declarations from the sponsor and the PI, a declaration on site conditioning, a sworn declaration of a fund for immediate care of participants until the insurance activates, a supply list and the fee receipt. Training in GCP and research ethics must be no more than three years old (Art. 67(q)).

Art. 68 limits authorization to investigational products that meet one of several conditions, such as authorization for human research by a regulator from a high-surveillance country. How Art. 68 applies to a device that has never been used in people, and whether later amendments change Art. 67: Confirm per study.

Items to confirm per study

• Device classification in each country, which drives several requirements (Costa Rica Art. 44(i))
• Panama: how DE 21 Arts. 88, 95 and 99 apply to investigational devices, and which committee reviews the study
• Chile: the ISP provisional-use dossier list, any exemption decree, and site accreditation under Art. 111 D
• El Salvador: the CNEIS document list and the import permit steps
• Peru: how Art. 68 applies to an FIH device, and any amendments to DS 021-2017-SA
• Apostille or legalization of each foreign document
• Committee forms and fees in every country
• What replaces a prior-agency approval letter when the device has none (Costa Rica Art. 44(h); El Salvador §6.4(17))

A practical order of work

1. Freeze the protocol version you will translate. Every country ties its filings to a dated version.
2. Build the device technical file to the El Salvador §7.2 list. It is the most detailed device list among the texts reviewed here.
3. Collect investigator CVs, licenses and GCP certificates early, and check their dates against the three-year limits in Costa Rica, Panama and Peru.
4. Line up the insurance policy for each country before submission. See our clinical trial insurance guide.
5. Plan the import-stage documents before ethics approval, not after. See importing investigational devices into Latin America.

Related reading: The universal Latin America FIH submission package · GMP attestation or ISO 13485 certificate? · How we qualify FIH sites and investigators · Protocol template for FIH devices

Frequently asked questions (FAQ)

What documents does every Latin American ethics committee ask for in a device first-in-human study?

In the texts reviewed for Costa Rica, El Salvador, Chile and Peru, the common items are the protocol, the investigator’s brochure, the informed consent form, investigator CVs and an insurance policy. Costa Rica, El Salvador and Peru also require GCP training evidence. Panama’s ethics committees apply their own document lists, so confirm those per study.

Do I need a GMP certificate or is a manufacturer declaration enough?

It depends on the country and the filing stage. Costa Rica accepts a manufacturer GMP statement at the ethics committee but asks for an authority-issued GMP certificate for customs release. El Salvador accepts a GMP certificate or a manufacturer declaration of conformity for devices. For other countries, confirm per study.

Does a device first-in-human study in Chile need ISP authorization?

Código Sanitario Article 111 A requires an ISP special authorization for provisional use for any device that is not registered or is used differently from its registration, after ethics approval. The Ministry of Health may exempt low-risk devices by decree, so confirm per study whether an exemption applies.

Must the investigators’ GCP training be recent?

Yes in several countries. Costa Rica asks for a CONIS-endorsed GCP course under three years old. Panama requires GCP courses approved by the national bioethics committee at least every three years. Peru asks for GCP and research ethics training no more than three years old.

Must documents be in Spanish?

Costa Rica requires an official Spanish translation of the protocol and investigator’s brochure. El Salvador requires all SRS filings in Spanish. Panama requires RESEGIS filings in Spanish. Peru asks for the protocol and brochure in Spanish and the original language. Chile requires the consent in Spanish or the participant’s native language.

Short answer: Whether a signed manufacturer attestation is enough depends on the filing stage as much as the country. In Costa Rica, the ethics committee accepts a manufacturer’s statement of Good Manufacturing Practice (GMP) compliance. The customs-release step that follows requires an authority-issued GMP certificate. Panama and El Salvador accept a certificate or a declaration at regulator review. Chile asks for an official certificate for imported pharmaceutical products. Peru asks for a GMP certificate or a document that guarantees compliance.

Sponsors of first-in-human (FIH) device and drug-device studies often raise this question at the feasibility stage. At bioaccess®, it is an operational item handled in study execution. For each filing, we map which quality document is required. We check that the attestation or certificate covers the right sites, product and lots. We sequence it so the import step doesn’t stall the first shipment. This guide sets out what the regulations say, with the primary source next to each requirement.

Terms that get mixed up

GMP attestation, declaration or constancia

A document signed by the manufacturer, usually by its quality head or qualified person (QP), stating that the investigational product was made in compliance with GMP or under a quality management system (QMS). The regulations use different words for it: constancia (Costa Rica), declaración de buenas prácticas de fabricación de persona calificada (Panama), declaración de conformidad por parte del fabricante (El Salvador).

GMP certificate

A certificate issued by a health authority after it has verified a manufacturing site. Spanish-language rules call GMP buenas prácticas de manufactura (BPM) or buenas prácticas de fabricación (BPF).

ISO 13485 certificate

A certificate from a certification body showing that a device manufacturer’s QMS conforms to ISO 13485, the medical device QMS standard of the International Organization for Standardization (ISO). It is not the same document as a GMP certificate issued by a health authority. None of the trial-specific texts reviewed below names ISO 13485 as a mandatory document for an investigational device.

Three filing stages, three different gates

• Ethics committee (EC): reviews the study package, which can include a GMP statement.
• Regulator or Ministry of Health review: evaluates the investigational product and its quality documents.
• Import or customs release: clears each shipment, and can ask for its own quality document.

Treat each stage as a separate checklist. A document accepted at one stage doesn’t automatically satisfy the next.

Country-by-country: attestation or certificate?

Country	Ethics committee	Regulator review	Import / customs release	Primary source
Costa Rica (drugs and devices)	Manufacturer constancia of GMP. Sterility certification for sterile devices.	No separate product review identified in this text. The national research council (CONIS) authorizes import.	Authority-issued GMP certificate for each manufacturing site, legalized or authenticated	Decreto Ejecutivo 44033-S, Alcance 111, La Gaceta 106 (14 June 2023), Arts. 44(r), 55(g)(vi)
Panama	Not specified in Arts. 95–99	GMP certificate or QP GMP declaration “or equivalents”	Based on RESEGIS registration, ethics approval and DNFD authorization	Decreto Ejecutivo 21 of 23 April 2026, Gaceta Oficial 30510-C, Arts. 95, 99
El Salvador (devices)	Not specified in the SRS guide	Manufacturer GMP certificate or manufacturer declaration of conformity. Sterility certificate where applicable.	Trial import permit tied to ethics approval and SRS opinion. ISO 13485 not listed.	SRS clinical-trial authorization guide, §7.2. SRS special import permits guide, §5.2.1.2
Chile (pharmaceutical products)	Accredited EC approval required before ISP authorization	For imported products: official certificate from the manufacturing country’s authority confirming authorization and GMP, or another document proving GMP compliance, legalized or apostilled	Customs destination certificate from ISP	ISP Resolución Exenta 5.161 (Diario Oficial, 7 January 2017), Arts. 2(2), 2(8), 17
Peru	Not addressed in Annex 5	Drugs: valid GMP certificate from the country-of-origin authority, or a document that guarantees compliance. Devices: the national authority sets the documents.	Not addressed in Annex 5	Decreto Supremo (DS) 021-2017-SA, Reglamento de Ensayos Clínicos, Annex 5, items 1(d) and 3

Costa Rica: attestation at the EC, certificate at customs release

For studies with drugs or biomedical equipment and materials (equipo y material biomédico, EMB, Costa Rica’s legal term for medical devices), the package for the ethics committee (Comité Ético Científico, CEC) must include a constancia that the product was made under GMP. Studies with sterile devices must also include a sterility certification. The requirement does not apply if a valid GMP certificate has already been filed, or to comparators. (Decreto Ejecutivo 44033-S, amending Reglamento 39061-S, Art. 44(r).)

Import works differently. Customs release for a research product needs authorization from the Consejo Nacional de Investigación en Salud (CONIS). That filing requires a GMP certificate for each establishment involved in manufacturing, issued by the regulatory authority of the manufacturing country, as a legalized original or authenticated copy (Art. 55(g)(vi)). The same exemption applies if a valid certificate is already on file. If the manufacturing country’s authority doesn’t issue this certificate for your product, confirm the accepted alternative with CONIS for each study.

Sourced timing: the CEC decides within one calendar month of filing (Art. 42). CONIS reviews customs-release documents within five calendar days, with one ten-business-day period to correct gaps (Art. 55(h)).

Panama: certificate or qualified-person declaration

For high-risk research using “medicamentos o productos para la salud humana”, the Dirección Nacional de Farmacia y Drogas (DNFD) evaluates the product before the trial starts. The filing goes through the RESEGIS research registry (Registro y Seguimiento de la Investigación para la Salud). It requires “certificados de buenas prácticas de fabricación del medicamento en investigación o declaración de buenas prácticas de fabricación de persona calificada o equivalentes”, plus a certificate of analysis and the investigator’s brochure. Import is based on RESEGIS registration, ethics approval and DNFD authorization. (Decreto Ejecutivo 21/2026, Arts. 95 and 99.)

Article 95 is framed broadly (“products for human health”), but the document list names the investigational medicamento. For investigational devices, confirm per study which GMP or QMS document DNFD accepts.

Sourced timing: DNFD responds within 15 business days (Art. 95).

El Salvador: certificate or manufacturer declaration

The Superintendencia de Regulación Sanitaria (SRS) guide for clinical-trial authorization lists device-specific requirements. They are a GMP certificate from the manufacturer “o declaración de conformidad por parte del fabricante”; a description of the manufacturing process; a manufacturer-issued sterility certificate with the sterilization method and validation (when applicable); test results; and a risk-management plan based on ISO 14971 (SRS guide, §7.2(a)–(h)). The device technical regulation separately requires the sponsor to give the principal investigator evidence (atestados) of QMS compliance for device production (Reglamento Técnico Salvadoreño, RTS 11.03.02:21, §6.1.2(d)).

For the trial import permit, the SRS import guide lists the protocol approved by the national research ethics committee (CNEIS), the SRS favorable opinion, the current CNEIS minutes, and the inventory authorized by the SRS (§5.2.1.2). ISO 13485 appears in that guide only for other permit types, such as devices for clinical use by a health professional, where it is an alternative to authorization from the agency of origin (§5.2.1.4).

Chile: official certificate for imported pharmaceutical products

Chile’s Instituto de Salud Pública (ISP) authorizes the use of pharmaceutical products in clinical trials under Resolución Exenta 5.161. For imported products, the applicant must attach an official certificate from the competent health authority of the country where the manufacturing sites are located. The certificate must confirm that the manufacturer is authorized and complies with GMP under World Health Organization (WHO) recommendations, “u otro documento que acredite el cumplimiento de las Buenas Prácticas de Manufactura”, legalized or apostilled if applicable (Res. Exenta 5.161, Art. 2(8)).

Whether a manufacturer’s own declaration counts as “otro documento” is not defined in the text, so confirm per study. The resolution covers pharmaceutical products. Whether a given drug-device combination follows this route depends on how it is classified: confirm per study. For device-only studies, see our Chile ISP device vs drug guide.

Sourced timing: ISP rules on a customs destination certificate within three business days (Art. 17). An authorization to use a product in a trial is valid for one year and is not renewed automatically (Art. 10).

Peru: certificate or a document that guarantees compliance

For a drug investigational product, the trial authorization needs a valid GMP certificate for the manufacturer, issued by the competent authority of the country of origin, “o documento que garantice su cumplimiento” (DS 021-2017-SA, Annex 5, item 1(d)). For biological products and medical devices, the national medicines authority (Autoridad Nacional de Medicamentos, ANM) sets the required certificates or documents (Annex 5, item 3). Confirm per study.

What a defensible GMP or QMS attestation should contain

None of these countries publishes a fill-in template. The checklist below follows the elements the regulations above ask about. Its structure borrows from the European Commission’s QP declaration template, which is a model, not a Latin American requirement.

• Manufacturer letterhead, date, and the signatory’s name and role (quality head or QP)
• Product name or code, model, and the lots or serial numbers covered
• Every establishment involved in manufacturing and sterilization, with addresses. Costa Rica’s import step asks for each establishment.
• The GMP or QMS standard the manufacturer complies with
• For sterile devices, a reference to the separate sterility certificate (Costa Rica Art. 44(r); SRS guide §7.2(d))
• Language, legalization or apostille where required (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8))

When you need a certificate instead

• Costa Rica, customs release: GMP certificate issued by the authority of the manufacturing country (Art. 55(g)(vi)).
• Chile, imported pharmaceutical products: official authority certificate, or another document proving GMP compliance (Res. 5.161 Art. 2(8)).
• Peru, drug products: country-of-origin GMP certificate, or a document that guarantees compliance (Annex 5, 1(d)).
• Panama and El Salvador: a certificate is one of two accepted options at regulator review (DE 21 Art. 95; SRS guide §7.2(a)).

Common sponsor mistakes

• Assuming the EC-stage attestation also clears import. In Costa Rica it doesn’t (Art. 55(g)(vi)).
• Sending an ISO 13485 certificate where a health authority’s GMP certificate is requested (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8)).
• Leaving out the separate sterility certificate for sterile devices (Costa Rica Art. 44(r); SRS guide §7.2(d)).
• Covering only the final assembly site when the text asks for every establishment (Costa Rica Art. 55(g)(vi)).
• Skipping legalization or apostille (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8)).

Timing you can plan around

• Costa Rica: CEC decision within one calendar month (Art. 42). CONIS customs-release review within five calendar days, plus one ten-business-day correction period (Art. 55(h)).
• Panama: DNFD response within 15 business days (DE 21/2026 Art. 95).
• Chile: ISP customs destination certificate within three business days (Res. 5.161 Art. 17). The use authorization is valid for one year (Art. 10).

We don’t cite timelines for El Salvador or Peru because the texts reviewed here don’t set them.

Kickoff checklist for the quality package

• List every manufacturing and sterilization establishment for the investigational product.
• Decide, country by country, whether you will file an attestation, a certificate, or both.
• Prepare a sterility certificate for sterile devices.
• Plan for legalization or apostille where the text requires it.
• Line up the import-stage document before the first shipment, not after ethics approval.

Related reading: Good Laboratory Practice (GLP), GMP and sterility for early feasibility device trials · Importing investigational devices into Latin America · Investigational device import calendar · Importer of record for clinical-trial devices

FAQ

Do I need an ISO 13485 certificate to run a first-in-human device trial in Costa Rica, Panama, El Salvador or Chile?

None of the trial-specific texts reviewed names ISO 13485 as mandatory. Costa Rica asks for a GMP statement at the ethics committee and an authority-issued GMP certificate at customs release. El Salvador accepts a GMP certificate or a manufacturer declaration of conformity. Panama’s device requirements and Chile’s device-only requirements should be confirmed per study.

Is a qualified-person GMP declaration accepted in Panama?

Yes. Decreto Ejecutivo 21 of 2026, Article 95, accepts GMP certificates or a qualified-person GMP declaration or equivalents for the investigational medicinal product. For devices, confirm the accepted document with the Dirección Nacional de Farmacia y Drogas per study.

Does Costa Rica accept a manufacturer attestation?

At the ethics committee, yes: Article 44(r) of the amended Reglamento 39061-S asks for a statement that the product was made under GMP, plus sterility certification for sterile devices. For customs release, Article 55(g)(vi) asks for a GMP certificate issued by the authority of the manufacturing country.

What does Chile’s ISP accept for imported pharmaceutical products?

Resolución Exenta 5.161 asks for an official certificate from the health authority of the manufacturing country confirming authorization and GMP compliance, or another document that proves GMP compliance, legalized or apostilled if applicable.

Sources: Arissa Medical press release of 8 October 2026 (arissamedical.com), NeuroNews International coverage of 8 October 2026 and 22 January 2024, and a ClinicalTrials.gov search run 15 October 2026. Public sources only. This page does not claim that bioaccess® ran, monitored, or advised on the Syntra study, and it does not claim the institute or its investigators as bioaccess® clients. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers.

If you searched Dr. Juan Gabriel Sordo, Juan Gabriel Sordo first-in-human, or Syntra principal investigator Chile, you found a real investigator in the public record. Arissa Medical names Dr. Juan Gabriel Sordo, interventional neuroradiology, as principal investigator of its Syntra™ intrasaccular-device first-in-human pilot at the Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago, Chile. A principal investigator is not the CRO.

bioaccess®’s position is simple and it is not adversarial: the investigator and the site run the cases. The First-in-Human CRO still owns ISP authorization, Law 20.120 Ethical-Scientific Committee review, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Emailing the PI is a good way to test investigator interest. It is not a regulatory plan.

What the public record says

• NeuroNews International, 22 January 2024: first patients enrolled in the first-in-human, early feasibility Syntra study; initial cases done at the Asenjo institute by principal investigator Dr. Sordo (listed with Clínica Santa María, Santiago). Source.
• Arissa Medical, 8 October 2026: 12-month angiographic follow-up complete in all 16 pilot patients, with 15 of 16 achieving adequate occlusion and no device-related serious adverse events. Dr. Sordo is quoted as principal investigator on the device’s intrasaccular approach for wide-neck aneurysms. Source; NeuroNews coverage.
• Oversight named: a UCLA-affiliated independent medical monitor and a blinded core lab. No CRO is named. Syntra is limited to investigational use, and the study is not listed on ClinicalTrials.gov as of 15 October 2026.

The facility-level page is here: Instituto de Neurocirugía Asenjo, Santiago: the site is not the CRO.

PI versus CRO

Workstream	Principal investigator	First-in-Human CRO
Clinical judgment and cases	Yes	Supports with protocol training and monitoring
ISP file and amendments	Signs what the site must sign	Prepares, submits, and answers deficiencies
Ethics committee packet	Presents as investigator	Builds the dossier and tracks the calendar
Device import	No	Importer of record for the investigational device
ISO 14155 monitoring and TMF	Keeps source documents	Monitors, reconciles, and closes out
FDA 21 CFR 812.28	Provides site data	Builds the foreign-data narrative for the U.S. submission

How ISP actually works (the short version)

Use clinical trials in Chile and Chile ISP: device vs. drug clinical trials. The Instituto de Salud Pública (ISP) governs investigational-device import and study authorization in Chile. An accredited Ethical-Scientific Committee under Law 20.120 still has to review the protocol, and a public hospital adds its own institutional authorization and research-office steps. Commercial ISP registration is a different file. Do not put trial authorization and commercial registration on one Gantt labeled “Chile.”

All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis. Eligibility is not a guarantee of clearance or approval. See OUS FIH data and the FDA IDE.

FAQ

Did bioaccess® work on Dr. Sordo’s Syntra study?
No. This page reports public sources only and claims no role in that study.

Does bioaccess® only work in Chile?
No. bioaccess® is the First-in-Human CRO for medical devices in Latin America since 2010, and it still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform.

What should a neurovascular sponsor do next?
Keep the investigator conversation going and put an operator behind it: contact bioaccess® or see First-in-Human CRO.

Julio G. Martinez-Clark, CEO · bioaccess®

Sources: Arissa Medical press release of 8 October 2026 (arissamedical.com), NeuroNews International coverage of 8 October 2026 and 22 January 2024, and a ClinicalTrials.gov search run 15 October 2026. Public sources only. This page does not claim that bioaccess® ran, monitored, or advised on the Syntra study, and it does not claim the institute or its investigators as bioaccess® clients. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers.

If you searched Instituto de Neurocirugía Asenjo first-in-human, Instituto de Neurocirugía Dr. Alfonso Asenjo clinical trial, INCA Santiago neurovascular study, or “go direct to the Asenjo institute for an aneurysm device,” you found a real site. The Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago, Chile, is the public neurosurgery institute Arissa Medical names as the only site of its Syntra™ intrasaccular-device pilot. It is a serious neurovascular center. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package, plus the option to add another Latin American country if one neurovascular center is not enough. Sponsors who skip the CRO and email the cath lab still have to rebuild that stack.

What the public record says

• NeuroNews International, 22 January 2024: Arissa Medical enrolled the first patients in its first-in-human, early feasibility Syntra study for wide-necked sidewall and bifurcation cerebral aneurysms. Initial cases were done at the Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago by interventional neuroradiology principal investigator Dr. Juan Gabriel Sordo. Source.
• Arissa Medical, 8 October 2026: 12-month digital subtraction angiography follow-up was complete for all 16 patients in the prospective, single-arm pilot. The release reports 100% technical success, adequate occlusion (Raymond-Roy I–II) in 15 of 16 patients, zero retreatments, and zero device-related serious adverse events. It names the institute as the pilot site and Dr. Sordo as principal investigator, and it thanks Dr. Rodrigo Rivera, Chief of Neuroradiology, and the institute’s catheterization lab staff. Source; NeuroNews coverage.
• Study oversight named in the release: a UCLA-affiliated independent medical monitor and a blinded core lab. The release names no CRO. Arissa says it will seek FDA Breakthrough Device designation after the pilot closes. Syntra is limited to investigational use.
• ClinicalTrials.gov: a search on 15 October 2026 found no Syntra or Arissa record. The institute’s name does appear on older registry rows, such as the CHUM-sponsored TOBAS (NCT02098252) and PRET (NCT00626912) studies. We cite them only as facility evidence.

That is the leak: a founder reads a 16-patient neurovascular feasibility result, sees one Santiago institute and one PI, and no CRO, and concludes the hospital ran the whole study. It did not run the regulatory stack on its own. Something always owns import, insurance, monitoring, and the dataset an FDA reviewer will ask about.

The site is the site. The CRO is the operator.

What a neurovascular institute can typically do when a sponsor “goes direct”:

• Discuss investigator interest and whether the aneurysm caseload fits the protocol.
• Share institutional ethics and research-office calendars.
• Run the cases in its biplane cath lab with its neuroradiology team.

What the institute is not built to own for an investigational device:

• ISP and ethics. The investigational-device import and study authorization file, plus the Law 20.120 committee packet and every amendment.
• Investigational import. Permits, customs, and device accountability. See importer of record for clinical trial devices in Latin America.
• Clinical trial insurance. Required. We will not invent a premium here.
• ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
• The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review once GCP and ethics documentation is in place. Eligibility is not clearance, and a site agreement does not produce it.

How ISP actually works (the short version)

Use clinical trials in Chile and Chile ISP: device vs. drug clinical trials. The Instituto de Salud Pública (ISP) governs investigational-device import and study authorization in Chile. An accredited Ethical-Scientific Committee under Law 20.120 still has to review the protocol, and a public hospital adds its own institutional authorization and research-office steps. Commercial ISP registration is a different file. Do not put trial authorization and commercial registration on one Gantt labeled “Chile.”

All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis. Eligibility is not a guarantee of clearance or approval. See OUS FIH data and the FDA IDE.

Not a critique of the hospital

The Instituto de Neurocirugía Dr. Alfonso Asenjo is one of Chile’s reference neurosurgery centers, and the Syntra pilot shows its team can run a first-in-human neurovascular program. Use the site when the protocol fits. Hire the operator. This page is distinct from Clínica Santa María Santiago, where Dr. Sordo has also been listed, and from Clínica Alemana de Santiago. Sharing Santiago is not a license to merge them. The investigator-level page is Dr. Juan Gabriel Sordo: a Chile FIH principal investigator is not the CRO.

bioaccess® still runs clinical trials in Colombia

bioaccess® is the First-in-Human CRO for medical devices in Latin America, founded in 2010, with Miami headquarters and its own CRO in Colombia. bioaccess® still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform. We pick the country the device needs.

Frequently asked questions

Can I contract the Instituto de Neurocirugía Asenjo directly for a device FIH?

You can start the conversation there. The institute can discuss investigator interest, caseload, and ethics calendars. It does not become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because it hosted a pilot. Contract the CRO, then let the CRO activate the site if the site fits.

Did bioaccess® work on the Arissa Syntra study?

No. This page reports public sources only and claims no role in that study.

Is Syntra on ClinicalTrials.gov?

Not as of a 15 October 2026 search. A sponsor-named site with no CRO in the story is exactly why this page exists.

Next step

If the search that brought you here was this institute, start with the operator: contact bioaccess® or see First-in-Human CRO.

Julio G. Martinez-Clark, CEO · bioaccess®

If you typed George Clinical (Emerald Clinical) into a search box, you are probably building a CRO shortlist. This article uses only what George Clinical (Emerald Clinical) publishes (georgesclinical.com/therapeutic-expertise/medical-devices-cro · emeraldclinical.com · emeraldclinical.com/about-us) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What George Clinical (Emerald Clinical) publishes

George Clinical came out of The George Institute in Australia and in 2025 became Emerald Clinical Trials, which says it is headquartered in Singapore. George Clinical's medical device page covers feasibility, pilot, Class II/III pivotal and post-market studies, and describes it as a specialized CRO in Asia-Pacific and the USA. Emerald says it has completed 600+ trials across 70+ geographies over more than 25 years, with strength in renal, cardiovascular and oncology research.

George Clinical (Emerald Clinical) vs bioaccess®

Dimension	George Clinical (Emerald Clinical)	bioaccess®
Core focus	APAC-origin full-service CRO, late-phase strength	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Post-market studies and surveillance, plus regulatory and pharmacovigilance services	Live multi-country sanitary registration and in-country holder service

Where each one fits

If the device program is a large pivotal or post-market study across Asia-Pacific, George / Emerald is a capable choice.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including George Clinical (Emerald Clinical), for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not George Clinical (Emerald Clinical) features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the George Clinical (Emerald Clinical) public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Biointelect into a search box, you are probably building a CRO shortlist. This article uses only what Biointelect publishes (www.biointelect.com/cro) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Biointelect publishes

Biointelect is a Sydney consultancy founded in 2011 that added a CRO. It lists medical devices among its therapeutic areas, plus first-in-human, Phase I–II and high-risk inpatient studies, and leans toward strategy, local sponsor and regulatory work. Leah Goodman is CEO.

Biointelect vs bioaccess®

Dimension	Biointelect	bioaccess®
Core focus	Australian consulting + CRO + local sponsor	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Australian market entry support: legal local sponsor, TGA submissions, Resident Director services and R&D Tax Incentive coordination	Live multi-country sanitary registration and in-country holder service

Where each one fits

If what you need is an Australian entity, local sponsor and R&D tax-incentive coordination around a Phase I unit, Biointelect fits.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Biointelect, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Biointelect features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Biointelect public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Datapharm Australia into a search box, you are probably building a CRO shortlist. This article uses only what Datapharm Australia publishes (datapharmaustralia.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Datapharm Australia publishes

Datapharm Australia, in Drummoyne, Sydney, calls itself Australia's original full-service CRO, founded in 1987. Its therapeutic list includes devices, diagnostics and first-in-humans, and its cardiovascular page cites implants and stents. Helen Allars and John Edington are its co-founders.

Datapharm Australia vs bioaccess®

Dimension	Datapharm Australia	bioaccess®
Core focus	Mid-market single-country Australian CRO, drug and device	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	Phase IV post-marketing and observational studies, and pharmacovigilance services	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need a single-country Australian device or first-in-human study with a long-established local CRO, Datapharm fits.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Datapharm Australia, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Datapharm Australia features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Datapharm Australia public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed iNGENū CRO into a search box, you are probably building a CRO shortlist. This article uses only what iNGENū CRO publishes (ingenucro.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What iNGENū CRO publishes

iNGENū CRO is a Melbourne, physician-led biotech CRO led by CEO Dr Sud Agarwal. It sells fixed-milestone pricing, claims costs 80–90% below US CROs and 30–60% below other Australian CROs, and about four-week ethics. In September 2025 it was named CRO for Sapu Nano's Sapu003 human trials.

iNGENū CRO vs bioaccess®

Dimension	iNGENū CRO	bioaccess®
Core focus	Lean Australian biotech CRO, drug-primary	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	FDA regulatory services and Phase 1–4 trials listed	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you are a lean US biotech looking for a low-cost Australian Phase 1, iNGENū is built for that.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including iNGENū CRO, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not iNGENū CRO features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the iNGENū CRO public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.