Running a First-in-Human Dermatology or Aesthetic Device Trial in Latin America: Sites, PIs and Outpatient Clinics

Short answer: A first-in-human (FIH) dermatology or aesthetic device study can run in an outpatient clinic in Latin America, but the clinic has to qualify as a research site under each country’s rules. In Costa Rica the site needs the health permit (habilitación) for its activity and the ethics dossier must describe the site and the emergency plan. In Panama an institution must issue a no-objection note before ethics review. El Salvador’s authorization guide asks for the research center’s establishment registration and technical director. Chile’s device-trial guide from the public health institute expects a documented site selection report and facilities that match the device’s intended setting. Pick the principal investigator (PI) and the clinic together, and plan the emergency pathway before you submit.

Why dermatology and aesthetic studies are different

Most device FIH guidance assumes a hospital: an operating room, an interventional suite, an intensive care unit down the hall. Many dermatology and aesthetic devices are used in a very different place. The intended setting is a private dermatology practice or an aesthetic clinic, the procedure is short, and the main endpoints are often visual: investigator grading scales, standardized photographs, participant-reported outcomes. The best investigators for these products are often dermatologists or plastic surgeons in private practice, not hospital department heads.

That is a good fit for an early study, because the study setting should look like the setting the device is designed for. It also means the ethics committee and health authority will look harder at things a hospital provides by default: the permit, the equipment, the emergency backup and the storage of the investigational device.

Can an outpatient clinic be an FIH site? Country by country

In short, none of these sources says a device FIH study has to be in a hospital. What they require is that the site is properly permitted for what it does, described accurately in the dossier, and backed by a credible plan for emergencies. Whether a particular private clinic’s permit category covers research activity, and which documents a given ethics committee wants for it, should be confirmed per study.

Choosing the PI: dermatologist or plastic surgeon

The right specialty follows the device and the procedure. A topical or energy-based skin device usually points to a dermatologist; a device used in a surgical or minimally invasive aesthetic procedure may point to a plastic surgeon. Either way, the paperwork is the same kind of evidence:

• Costa Rica: the CEC dossier includes each team member’s curriculum vitae, ID, current professional license or college registration, and a Good Clinical Practice (GCP) course certificate less than three years old endorsed by the National Health Research Council (CONIS, Consejo Nacional de Investigación en Salud), plus investigator accreditation (Reglamento 39061-S, Art. 44(z) and (aa)).
• Chile: the PI must be able to show a team with “la cualificación académica y la experiencia” for the study, documented with current CVs (ISP guide, section 10.3(b)).
• Panama and El Salvador: investigator documents go to the ethics committee and, in El Salvador, the SRS application lists investigator details. Specific credential requirements should be confirmed per study (Panama DE 21; SRS guide).

Beyond the documents, ask practical questions: has the investigator run a device study before, can the clinic see the target population in the recruitment window you need, who covers when the PI is in surgery, and does the team have time for study visits on top of a busy private practice? Our guide to qualifying FIH sites and investigators in Latin America covers the general checklist.

Confirming the clinic has the equipment

Sponsors often ask how to confirm that a clinic really has the imaging and procedure equipment the protocol needs. The answer is to verify it in person and write it down. Chile’s guide makes the site selection report an explicit document (section 6.8), and Costa Rica’s dossier asks for a description of the site and facilities (Art. 44(p)). A practical site qualification visit for a dermatology study checks:

• the procedure room and the equipment the device needs (power, ventilation, any accessories), against the instructions for use;
• the photography setup: the same camera and settings, fixed lighting, fixed participant positioning and a written procedure, so images are comparable across visits and sites;
• maintenance and calibration records for any measuring equipment used for endpoints;
• a locked, access-controlled place to store the investigational device under the manufacturer’s conditions. Costa Rica requires the product to be kept “bajo las condiciones ambientales especificadas por el fabricante o patrocinador, en un lugar limpio, seguro y con restricción de acceso” (Reglamento 39061-S, Art. 58(a));
• where source documents and photographs will be kept, so the file is ready for monitoring and for review by the US Food and Drug Administration (FDA) under 21 CFR 812.28 (Code of Federal Regulations, CFR) if the data will support a US submission.

If the protocol uses photographs taken by participants at home, treat that as a separate method to describe and justify in the protocol, and check with the ethics committee how it wants consent, privacy and image transfer handled.

The emergency pathway is the question committees ask first

An outpatient clinic does not have a hospital’s emergency backup on site, so the dossier has to show one. Costa Rica asks the sponsor to explain how emergencies and serious adverse events will be handled and “a cuáles centros debe acudir el participante” (Art. 44(pp)). Chile’s guide notes that sites may need “equipos y capacidades adicionales” to make sure the necessary safety precautions are present (section 6.8). In practice, that means a named referral hospital, a written transfer procedure, emergency equipment and trained staff at the clinic, and a 24-hour contact for participants. It also means insurance that covers the study at that site; see site insurance vs sponsor policy.

Skin types, ages and the US label

If the FIH data will feed a US submission, think early about which skin types and ages the device is meant for. Recruiting across a range of Fitzpatrick skin types at the first study gives you safety data in the population you plan to treat, rather than finding out later. No source reviewed for this post sets a skin-type quota for an FIH study; it is a design decision to discuss with FDA. See Fitzpatrick skin type diversity in clinical trials.

Device category still comes first

Before you choose a clinic, confirm that the product is regulated as a device in each country and in the US. Aesthetic products can sit near the cosmetic line. FDA’s microneedling guidance, for example, treats penetration beyond the stratum corneum into living skin as evidence of device status (FDA guidance). In Chile, ISP special authorization applies to trials of a “producto farmacéutico o dispositivo médico” (Código Sanitario, Art. 111 A).

Where bioaccess® fits

bioaccess® runs first-in-human and early feasibility medical device studies in Latin America. For dermatology and aesthetic sponsors, we help shortlist investigators, qualify outpatient clinics in person, and assemble the site, emergency and storage documents each ethics committee and health authority expects.

Related reading

• Microneedle Patches: Device, Combination Product, or Cosmetic? Planning Your First Human Study
• 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)
• How to qualify FIH sites and investigators in Latin America
• Latin America FIH patient recruitment and feasibility
• Fitzpatrick skin type diversity in clinical trials
• Costa Rica FIH activation calendar: CONIS and CEC
• Rapid startup archetypes: Chile, Costa Rica, Panama, El Salvador
• Building an inspectable ISO 14155 file for a Latin America device FIH study
• Investigational device import calendar for Latin America FIH studies
• Site profile: Clínica Dermacross, Santiago

FAQ

Can a first-in-human device study run in an outpatient dermatology clinic in Latin America?

Yes, if the clinic qualifies as a research site under local rules. None of the sources reviewed requires a hospital, but they require proper permits, an accurate description of the site, and a credible plan for emergencies. Confirm per study that the clinic’s permit category covers the research activity.

What does Costa Rica require of a research site?

Costa Rica’s research regulation defines a research site as any place where research activities happen or investigational products are stored or dispensed, and says it must hold the health permit for its activity. The ethics dossier includes a site description, current permits for laboratories and facilities, and an explanation of how emergencies will be handled and where participants should go.

What does Panama require before ethics review at an institution?

Executive Decree 21 of 2026 says any protocol carried out in an institution needs a prior note of conformity or no objection from the institution’s competent administrative authority before ethics review. A multicenter study is approved by one accredited bioethics committee, and each additional center submits documents for inclusion.

Should the PI be a dermatologist or a plastic surgeon?

It depends on the device and the procedure. Topical and energy-based skin devices usually fit a dermatologist, while devices used in surgical or minimally invasive aesthetic procedures may fit a plastic surgeon. In both cases the ethics dossier needs current CVs, licenses and GCP training records.

How do you confirm that a clinic has the right equipment and imaging?

Through an in-person site qualification visit documented in writing. Check the procedure room and equipment against the instructions for use, the photography setup and written imaging procedure, calibration records, secure storage for the investigational device, and where source documents will be kept.

What emergency arrangements does an outpatient FIH site need?

A named referral hospital, a written transfer procedure, emergency equipment and trained staff at the clinic, and a round-the-clock contact for participants. Costa Rica’s ethics dossier explicitly asks which centers participants should go to in an emergency.