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.