Category: Preparing for First-In-Human Studies

Sponsors still put “El Salvador” on one regulatory Gantt with a single 30–60 day band. That is the mistake. A first-in-human (FIH) or early feasibility study (EFS) for a medical device in El Salvador runs as a CNEIS ethics vote plus an SRS clinical-investigation authorization. Putting the same Class III implantable on the Salvadoran market later is a DNM/SRS registro sanitario. Same clock language. Different petition, different importer, different success criterion.

If the board slide says “El Salvador approved in 30–60 days,” ask which file. Trial authorization is not a commercial registro. Confusing them delays first patient and later stalls commercial import.

Two files, one country

The Superintendencia de Regulación Sanitaria (SRS), established in August 2024 under the Ley de la Superintendencia de Regulación Sanitaria (7 August 2024), replaced the Dirección Nacional de Medicamentos (DNM) as El Salvador’s national sanitary authority. Ethics for clinical research sits with the Comité Nacional de Ética de la Investigación en Salud (CNEIS). Parallel SRS and CNEIS review is already published on the El Salvador clinical-trials hub as the reason that country page shows a 30–60 day study-startup band.

For a U.S.-based medtech sponsor, the practical split looks like this:

• Trial file: Spanish protocol package, investigator brochure, informed consent, CNEIS ethics package, SRS investigation authorization, investigational labeling, ISO 14155 monitoring plan, and the import story for units that will only be used in the study. The live step-by-step FIH guide already names the SRS-CNEIS-ES digital platform and the user manual issued 17 November 2025. Use that manual. Do not invent article numbers from CNEIS reforms you have not opened.
• Registro file: commercial sanitary registration through DNM/SRS for manufacture, import, storage, distribution, and promotion of a commercial device, with a Salvadoran party the authority will treat as responsible for that certificate — not a PI’s clinic stamp and not a named hospital that happens to have run FIH.

Hospital El Salvador appears on the public landscape as infrastructure. It is not a hospital bioaccess® operates, and it is not the commercial titular on a registro. Public San Salvador sites are sites. They are not the CRO and they are not the holder.

The same 30–60 day language also appears on the market-access hub for El Salvador commercial registration (experience-based). That is the punchline: identical band, different petition. Do not merge the two clocks into one Gantt bar labeled “El Salvador.”

What FDA reviewers will ask later

If the El Salvador FIH is meant to support a U.S. IDE or marketing file, design the investigation so the evidence room can satisfy 21 CFR § 812.28 (acceptance of data from clinical investigations conducted outside the United States). That regulation expects GCP, independent ethics review, and a device comparable to the version you will put in front of FDA.

ISO 14155 is the device GCP bridge FDA has publicly recognized for foreign investigations. A clean SRS investigation letter does not replace an inspectable trial master file. Keep device accountability, deviation logs, monitoring reports, and the CNEIS correspondence in one place from day one. Eligibility of foreign data under 812.28 is not a clearance prediction.

El Salvador is a lead FIH jurisdiction for bioaccess®, with Miami headquarters and a dollarized economy already published on the country hub. None of that converts a trial authorization into a selling license. Do not put a single “El Salvador clock” on the Gantt and call it done.

Import: investigational units are not the registro SKU

A commercial DNM/SRS registration number does not clear investigational kits. Do not put a cousin SKU’s registro on the airway bill “because the PI knows customs.” Name the trial importer before CNEIS stamps the protocol. Map every investigational model, accessory, and spare to the investigation-authorized list. Outer labels must read as investigational, with lot or serial traceability that matches the accountability log at the site.

After last patient, close investigational inventory under the trial rules. Leaving units “for the hospital” without a new sanitary path is a new regulatory event, not a courtesy. The commercial registro track — when you actually need it — is a separate workstream with its own importer and its own holder.

Holder vs distributor (commercial track only)

When you later want Salvadoran market access, SRS will look for a local face on the sanitary registration: renewals, variations, labeling, and vigilance. A distributor who only sells stock is not automatically that holder. If the holder relationship breaks, the registro does not quietly follow the freight forwarder — you re-file.

That commercial conversation belongs on a separate workstream from the investigation calendar. Running them as one “El Salvador regulatory” workstream is how teams discover, mid-enrollment, that nobody can import the commercial launch SKU. The market-access hub already states that commercial registration is a second file. Keep it that way inside your own team.

One-page gate before first patient in El Salvador

Write these lines with owners and document IDs before you book site initiation:

1. Authority map. SRS investigation plus CNEIS ethics for the study. DNM/SRS registro only if a parallel commercial file is truly in scope this year.
2. Ethics + investigation sequence. Same protocol version and the same Spanish informed-consent text in both packages. Submit through the SRS-CNEIS-ES platform already named on the live FIH guide; use the 17 November 2025 user manual as the operational reference.
3. Investigational importer. Legal name and the document that ties the shipment to the investigation authorization — not a commercial registro number.
4. Device list. Every unit that will sit in the site accountability log, including accessories.
5. ISO 14155 file owner. Who can produce monitoring, accountability, and ethics letters within 48 hours if FDA or a notified body asks.
6. Commercial holder (optional, separate). If launch is real, name the Salvadoran titular and keep that file off the FIH critical path until first patient is locked.

Where teams burn weeks

Three patterns show up repeatedly on El Salvador device files:

• One 30–60 day bar for both desks. Treating the published study-startup band and the experience-based commercial registration band as the same petition. They share clock language. They do not share a dossier.
• Registro number on investigational freight. Using a commercial DNM/SRS certificate for a predicate or related model to move FIH units. The investigational article is not that registered product.
• One Spanish translation for both desks. The informed-consent and brochure language for CNEIS and the investigation is not the commercial IFU SRS will later lock on a registro. Mixing them creates labeling debt on both tracks.

Fix the patterns on paper before translators start. Re-translation after first patient is a protocol amendment problem, not a word-processing problem. Sibling posts on the same split for other LATAM markets — including the CRO in El Salvador category page — already make the same point: trial and registro are not one Gantt.

Practical next step

This week, split the El Salvador slide into two columns: CNEIS/SRS investigation and DNM/SRS registro. If the same person owns both without two dossiers, two importers, and two success criteria, you do not have an El Salvador plan — you have a hope. bioaccess® runs FIH/EFS execution across Latin America, including El Salvador as a lead FIH jurisdiction from Miami, and holds LATAM registration/IOR work as a separate market-access track; treat El Salvador the same way inside your own team. Start from the clinical-trials hub for the investigation column and the market-access hub for the registro column — and do not collapse them because both say 30–60 days.

US orthopedic and biomaterial startups still treat first-in-human as a domestic IDE problem. The calendar that actually eats a year is not the Food and Drug Administration’s 30-day Investigational Device Exemption clock under 21 CFR 812.30. It is the stacked queue: Q-Sub, a significant-risk IDE package, institutional review board review, hospital contracting, and the 12–18 month feasibility-trial wait already published on our Panama first-in-human guide. Panama’s Ministerio de Salud (MINSA) reviews high-risk investigational device protocols — including Class III implants and innovative biomaterials — under a written rulebook that puts first patient in months, not years.

I am Julio Martinez-Clark, CEO of bioaccess®. This is the Class III / US-startup cut: MINSA’s investigational review, Panama City surgical sites, cost and timeline versus a US IDE feasibility path, and the 21 CFR 812.28 acceptance criteria that decide whether the data can enter an IDE, 510(k), De Novo, PMA, or HDE file. For insurance bands and the country table, use the first-in-human guide. For published clocks, use the Panama clinical-trials hub and the CRO in Panama page.

Two MINSA files — do not mix Class III registro with the trial

Panama runs two device desks. Confusing them is how a startup burns a quarter.

Investigational use sits with MINSA through the Dirección Nacional de Farmacia y Drogas, and with institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). The governing instruments are Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026, published in Gaceta Oficial No. 30510-C, implementing Titles III and IV of that law. MINSA’s hub is Regulación de Investigación para la Salud. The live explainer is Panama’s Decreto 21 of 2026 — Type II-accredited committees for clinical trials, RESEGIS registration before start, ordinary ethics review capped at 20 business days, parallel MINSA + ethics review for high-risk protocols, and 24-hour / 15-day serious-adverse-event clocks. Those are decree clocks, not a hub median.

Commercial Class III sale is a different statute: Ley 90 of 26 December 2017, as modified by Ley 92 of 12 September 2019, regulated by Decreto Ejecutivo No. 490 of 4 October 2019. Risk class for registro sanitario follows current GHTF/IMDRF rules; the Dirección Nacional de Dispositivos Médicos is the classifying authority. The Panama MINSA market-access page already states the single Authorized Representative model. That holder role does not replace a MINSA/CNBI trial authorization, and a trial authorization is not a license to sell. Keep commercial registro off the first-in-human critical path.

When I write “Class III first-in-human trials,” I mean significant-risk investigational implants, orthopedic hardware, and biomaterials that a US reviewer would treat as Class III / PMA-directed or as a high-risk De Novo. High-risk investigational protocols are the set Decreto 21 sends through parallel MINSA + ethics review. Panama does not skip review. What it skips is a US-style IDE as a precondition to first implant.

MINSA’s investigational framework for biomaterials and Class III devices

What actually goes in, already listed on the Panama hub:

• Spanish protocol package — protocol, investigator brochure, informed consent, and insurance. Foreign-language drafts do not substitute.
• RESEGIS — Registro y Seguimiento de Investigación para la Salud. Standard projects receive a registration receipt in three business days. The public list is open, no login. It is a general health-research registry, not devices-only. Your protocol still has to be in it before start.
• Type II-accredited committee — clinical trials sit a CNBI-registered Type II committee, not an ad-hoc hospital chat.
• Parallel MINSA + ethics — high-risk work, which is where Class III implants and novel biomaterials live, does not wait for one desk to finish before the other opens.
• CNBI evaluation axes already on the FIH guide: scientific merit and design adequacy; risk-benefit and informed-consent adequacy; investigator and site infrastructure; preclinical data as a coherent safety narrative, not a GLP checklist; patient-protection measures, monitoring, and stopping rules.

I am not inventing a PAHO/WHO Level 4 badge for MINSA or CNBI. INVIMA Level 4 stays a Colombia fact. Panama’s claim is a 2026 executive decree, a public research registry, accredited Type II committees, and a MINSA desk that will read a high-risk device protocol in Spanish.

Preclinical expectations are already on the FIH guide and the early-feasibility GLP/GMP/sterility article. R&D-grade (non-GLP) data can support a Panama ethics file when the ISO 14971 file and the investigator brochure tell a coherent safety story. That is not a waiver of biocompatibility, sterility, or bench performance.

Panama City sites and surgical investigators

bioaccess® has coordinated first-in-human device studies at JCI-accredited hospitals in Panama City since the early 2010s — the public line on the hub. We do not operate a named Panamanian hospital. A city is not a site contract. Named principal investigator and named ward are a feasibility deliverable, not a sentence I will invent here.

Landscape hospitals already named on the FIH guide, as city infrastructure: Hospital Santo Tomás, Hospital Nacional, Instituto Oncológico Nacional, and Punta Pacífica (Johns Hopkins Medicine International affiliate). The public Axoft FINESSE first-in-human cases ran at The Panama Clinic — already on our FDA acceptance guide. That is a site of record for a published program. It is not a bioaccess® facility.

What a US orthopedic or biomaterial sponsor actually needs in that city:

• Qualified surgical investigators who already implant in the indication. Therapeutic areas already published on the hub: spine, orthopedic, vascular, neurotechnology. Many physicians at major centers completed US residencies or fellowships. The workforce is bilingual. That is an operating fact on the hub, not a tourism line.
• Early-feasibility n. Panama City metro is about 2 million people. Early-feasibility enrollment is typically 5–20 patients — the right size for a Class III first-in-human cohort. Rare disease or a larger n belongs in a multi-country plan (Panama plus El Salvador plus Brazil is the example already on the FIH guide).
• Investigational import. Ethics approval letter, investigator brochure, importation permit. Customs is among the more efficient in Latin America (Canal / Colón Free Zone). bioaccess® runs that file. Do not hand investigational units to a commercial distributor “because they already import.”
• Same clock as Miami. Panama City is a three-hour flight from Miami and sits on US Eastern Time.

Cost and timeline versus a US IDE feasibility path

Use numbers we have already published. Ask for a study-specific calendar.

Panama (hub and FIH guide): ethics approval 3–5 weeks, with MINSA clearance available concurrently on the high-risk track; 6–8 week average to first patient with bioaccess® coordination; 3–5 month conservative envelope including site prep; $12,000–$22,000 per patient; a 10-patient first-in-human study typically $200,000–$300,000; clinical-trial insurance typically $5,000–$15,000 by risk class and enrollment; US dollar (Balboa pegged 1:1).

United States (same pages): 6–12 months IDE + IRB on the hub table; 12–18 months to first patient on the FIH-guide country table. The statutory IDE review is 30 days. The year you lose is Q-Sub cycles, significant-risk packaging, IRB, and hospital contracting — the feasibility-trial queue this page names. Per-patient cost $40,000–$75,000. A separate IDE is required for significant-risk early feasibility. Panama requires MINSA/CNBI, not a US-style IDE, to start an investigational implant.

Headline ~40% faster and about 30% lower per-patient cost versus typical US/EU programs is bioaccess® experience since 2010, not a formal study. FDA’s Early Feasibility Studies program exists; that does not empty the US site queue. A novel biomaterial or Class III orthopedic implant with no predicate is still a legal event at a US hospital. Panama City surgical services treat it as a protocol they have run.

FDA 21 CFR 812.28 — the acceptance criteria, not a slogan

Foreign clinical data is eligible for FDA submission and review under 21 CFR 812.28 (final rule, 83 FR 7386, 21 February 2018). Eligibility is not clearance or approval. bioaccess® designs Panama studies for that conversation. We do not promise an FDA stamp.

Section 812.28(a) says FDA will accept information from a well-designed, well-conducted investigation outside the United States to support an IDE or a device marketing application (PMA under section 515, HDE under 520(m), 510(k), or De Novo) when three conditions are met:

1. Good clinical practice. The rule defines GCP as a standard for design, conduct, monitoring, auditing, recording, analysis, and reporting that keeps data credible and protects subjects. GCP here includes independent ethics-committee review and approval before initiation, continuing IEC review, and documented freely given informed consent. FDA has stated that conformance with ISO 14155:2020 will generally satisfy the GCP requirement of 812.28 — already on our FDA-acceptance guide. Investigations initiated on or after 21 February 2019 must conform to the 2018 foreign-data framework.
2. Supporting information in 812.28(b). For a significant-risk device as defined in 812.3(m) — the Class III / biomaterial first-in-human case — submit the full (b) set: investigators and sites; protocol and results; a statement that the investigational device is identical to the US device or a detailed comparison; valid scientific evidence under 21 CFR 860.7 if you claim safety and effectiveness; IEC identity meeting 812.3(t); consent, monitoring, and investigator GCP training.
3. FDA can validate the data through an onsite inspection or other appropriate means if the agency deems it necessary. A Panama file that cannot be inspected is not an 812.28 file. Electronic data capture, device accountability, and source documents that survive an English-speaking inspector are part of the design, not a later translation job.

Section 812.28(e) is the residual clause: even when a foreign study does not fully meet paragraph (a), FDA may still accept the information if it believes the data are credible and accurate and that subject rights were adequately protected. Do not plan to live in (e). Build (a). Parallel rule already cited on the FDA-acceptance guide: 21 CFR 814.15 for foreign data in PMA applications. If the Panama protocol is meant to support a later US IDE, file a Q-Sub / Pre-Sub before you lock endpoints (written feedback in 75 calendar days). Endpoints and inclusion criteria have to be relevant to the intended US population; site standard of care has to be comparable to US practice.

Public programs already on the FDA-acceptance guide: Axoft FINESSE (first four cases at The Panama Clinic; FDA Breakthrough Device Designation in 2022); Newrotex (ethics approval in Panama; FDA Pre-Sub for a 510(k) using LATAM data); ReGelTec HYDRAFIL (Colombia early-feasibility, then FDA IDE for a US pivotal). Those names are already public. I am not adding unpublished sponsors or devices under development.

Where Class III teams burn the Panama calendar

• Treating Decreto 21 as optional. High-risk protocols get parallel MINSA + ethics. Skipping RESEGIS or sitting a committee that is not Type II-accredited is not a shortcut.
• Mixing commercial Class III registro (Ley 90 / Decreto 490) into the trial quote. Different directorate, different dossier, different importer.
• Assuming GLP certificates are the ethics question. CNBI reads the risk-benefit narrative. Bring ISO 14971 and a complete investigator brochure.
• Writing the informed consent in English and “translating later.” 812.28 wants documented consent the IEC actually approved. For FDA use, include the 21 CFR 50.25 elements. Spanish first.
• Changing the device after first implant without a comparability memo. 812.28(b)(5) is unforgiving.
• Reading this page as “leave Colombia.” We still run first-in-human work in Colombia when the device, sites, and file fit. INVIMA clocks are managed by our Colombian legal entity. Panama is a MINSA/CNBI country category. El Salvador is a lead first-in-human jurisdiction under DNM/SRS. If a protocol fits more than one, say so. We will not flip one country into the other.

If you are a US orthopedic or biomaterial startup staring at a 12–18 month domestic feasibility queue, send bioaccess® the protocol stage, device risk class, intended US filing, whether the investigational unit is identical to the US unit, and whether you also need a later MINSA commercial file. We will tell you how the MINSA/CNBI clock would run.

Explore Panama trial capabilities at bioaccessla.com/clinical-trials-panama or submit a study inquiry. Related: CRO in Panama, Decreto 21 of 2026, and the Panama first-in-human guide.

I still hear the same sentence about Panama: small country, hard to see what is running, so treat it as a black box.

That sentence is now a file-handling failure.

On 23 April 2026, Panama published Decreto Ejecutivo No. 21 in Gaceta Oficial Digital No. 30510-C.¹ The decree reglamenta Títulos III and IV of Ley 84 of 14 May 2019, the statute that already gave the country a health-research law.^1,2 Artículo 2, numeral 9 of the decree names the tool: Plataforma web RESEGIS, the Ministerio de Salud platform for registro y seguimiento of health-research projects.¹

MINSA did not hide that list behind a consultant login.

The official Guía introductoria a la Plataforma RESEGIS is blunt. “Para ver la lista pública de los protocolos de investigación registrados no es necesario tener un usuario activo en la plataforma, cualquier persona puede ver y acceder a la lista pública.” The same page tells you how to download that list as Excel. A second no-login module, “Ver estadísticas,” is open the same way.³

The live public table sits at the no-login RESEGIS list.⁴ The columns are not a teaser. They include consecutivo, Estado en MINSA, Seguimiento CBI, title, principal investigator, site, corregimiento, registration date, health region, institutional ethics committee, ethics-approval date, funder, Universal Trial Number, executor, and enrollment status.⁴ You do not need a RESEGIS user to open that page. You need a browser.

I pulled the public table on 28 August 2026. It had 1,890 rows. 1,808 were REGISTRADO. 72 were EVALUADO. Ten were EN EVALUACION.⁴ That is a general health-research docket, not a device-only register. Some rows look like platform tests. Filter before you brief a board. Do not treat a row as a bioaccess® study unless that fact is already on bioaccessla.com.

The public file is the protocol list, not the whole platform. Investigator follow-up and CBI follow-up screens are login-gated. That is a user role. It is not a reason to call the docket secret. The list MINSA told the public to download is the list that is already public.

The industry still writes Panama as if Ley 84 were the last word and the country were too small to track. Decreto 21 switched the registry language on. The consultants who still sell “Panama opacity” have not opened the Excel.

What the decree actually changed for a trial, as opposed to a tourist brochure, is narrower than a destination essay and more useful.

Artículo 19 splits committee accreditation. Tipo I is limited to minimum-risk work, or a minor increase above that floor. Tipo II covers that set plus intervention research, including clinical trials.¹ A first-in-human device protocol is not a Tipo I file. If the ethics committee on the row is not accredited for trials, you do not have a trial committee. You have a paperwork problem.

Artículo 44 is the ordinary ethics clock: a maximum of twenty business days from a complete file. That is the first-instance CBI review. Do not collapse it into the separate CNBI-as-superior-instance clock.

Artículo 79 says a clinical trial’s details must be in a publicly available, freely consultable registry that meets WHO standards before the trial starts in Panama. Artículo 82 says the accredited committee must see the comprobante del registro before it certifies approval or exemption. The Excel is not a courtesy. It is the public face of a file the decree already made a start condition.

Artículo 91 is the high-risk line. MINSA’s evaluation of those protocols and the ethics review se realizarán simultáneamente. The MINSA review does not stop the committee clock.¹ A clinical-trial authorization and a commercial MINSA registration are still different files. The public RESEGIS list does not give you a sanitary registration, and a sanitary registration does not authorize an investigational lot.

The 20 May 2026 bioaccess® reading already published that split.^5,6 The article numbers above are the cite.

That is the operational point. Opacity was the old excuse for skipping Panama diligence. The current failure mode is the opposite: paying someone to describe a country whose protocol list is already a public spreadsheet.

Open the list before you write the feasibility memo. Confirm the committee type, the MINSA estado, the site, and whether a UTN exists. If the row is not there, you do not have a registered protocol. If the row is there and the estado is EN EVALUACION, you do not have a start. If the title is a test string, you do not have a study.

I am not asking anyone to treat Panama as large. I am asking them to stop calling a no-login Excel an intelligence gap.

Related bioaccess® pages

• Decreto 21 of 2026: what the new clinical research rules mean for sponsors (20 May 2026). The decree reading. This page is the public docket / Excel / opacity-myth cut.
• Clinical trials in Panama
• CRO in Panama
• How much animal / preclinical data for a Panama FIH
• Why Panama is used for first-in-human device studies

References

1. República de Panamá, Ministerio de Salud, Decreto Ejecutivo No. 21 de 23 de abril de 2026, “Que reglamenta los Títulos III y IV de la Ley 84 de 14 de mayo de 2019,” Gaceta Oficial Digital No. 30510-C (jueves 23 de abril de 2026). Official PDF: https://minsa.b-cdn.net/sites/default/files/publicacion-general/decreto_ejecutivo_no_21_de_23_de_abril_de_2026_-_reglamenta_titulos_iii_y_iv_ley_84_de_14-5-2019_investigacion_en_salud.pdf
2. Ministerio de Salud de Panamá, Regulación de Investigación para la Salud (Ley 84 de 14 de mayo de 2019; Decreto Ejecutivo N. 21 de 23 de abril de 2026). https://www.minsa.gob.pa/informacion-salud/regulacion-de-investigacion-para-la-salud
3. Ministerio de Salud de Panamá, Guía introductoria a la Plataforma RESEGIS. “Para ver la lista pública de los protocolos de investigación registrados no es necesario tener un usuario activo en la plataforma, cualquier persona puede ver y acceder a la lista pública.” Official PDF: https://www.minsa.gob.pa/sites/default/files/publicacion-general/guia_introductoria_a_la_plataforma_resegis_0.pdf
4. Plataforma RESEGIS, Lista de Proyectos (no-login public table). https://resegis2.integrait.co/index.php/listprojects. Snapshot on disk 28 August 2026: 1,890 public rows.
5. Julio G. Martinez-Clark, “Panama’s Decreto 21 of 2026: What the New Clinical Research Rules Mean for Sponsors,” bioaccess®, 20 May 2026. https://bioaccessla.com/blog/panama-decreto-21-2026-clinical-research-regulation-what-sponsors-need-to-know
6. bioaccess®, “Clinical trials in Panama.” https://bioaccessla.com/clinical-trials-panama

The question on almost every first-in-human and early-feasibility device call is the same: what preclinical testing do I need to run a medical-device trial in Latin America? Sponsors want a 21 CFR Part 58 list. Latin America does not publish one.

The region answer, already on the live bioaccess® GLP / early-feasibility guide, is this: Brazil, Panama, and El Salvador accept R&D-grade (non-GLP) preclinical data for early-feasibility device studies. The file that gets read is a coherent risk-benefit narrative — an ISO 14971 risk-management file plus an investigator’s brochure — not a GLP stamp. Country pages are cuts of that answer. The Panama cut is already live at how much animal / preclinical data for a Panama FIH. Do not duplicate it here.

This page does not prescribe a required animal n, species, or duration for a named device. Device class, contact duration, and the specific ethics committee still decide.

What “enough” means in official text

Chile’s Agencia Nacional de Dispositivos Médicos published the official Guía de Investigación Clínica de Dispositivos Médicos en Humanos. Buenas Prácticas Clínicas (ANDIM, May 2026; linked from ANDIM’s technical-guides page). Principle 3(d) of that guide is the gate in one sentence: the clinical and non-clinical information available on the investigational product must be sufficient to support the proposed clinical investigation. The guide does not name GLP, BPL, or 21 CFR Part 58.

For first-in-human and preliminary-feasibility stages, the same official guide puts the weight on preclinical / non-clinical testing and on risk evaluation, and it says those evaluations must be exhaustive. Traditional feasibility and pivotal work can add clinical data. The investigator’s manual (Manual del Investigador) exists to give the principal investigator enough safety and performance data from preclinical or clinical investigations to justify human exposure. Design justification is based on the preclinical data plus a clinical evaluation. Risk is estimated under ISO 14971 (Chilean NCh-ISO 14971:2022). The “informe de análisis de riesgo” is defined as the set of clinical and non-clinical data relevant to evaluating the device in humans.

ANDIM also writes the limit we keep on this page: given the diversity of devices and risks, the guide does not claim to be a comprehensive, device-specific testing menu. That is the official “show us what convinces you it is safe” posture — not a consultancy line.

Panama’s current clinical-research rulebook is Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C), which implements Titles III and IV of Ley 84 of 14 May 2019. Both instruments are listed on MINSA’s official Regulación de Investigación para la Salud page. The live Panama cut already records what that rulebook does not add: a required animal n, species, or duration, and a hidden GLP animal mandate. Read the Panama page for the country file. This page is the region parent.

Brazil, Panama, El Salvador — the early-feasibility cut

The live GLP / GMP / sterility guide is the published bioaccess® operational record for early-feasibility device studies we have run. Three countries accept R&D-grade (non-GLP) preclinical data:

• Brazil. For early-feasibility studies not intended for local market clearance, the published path is CEP (institutional ethics) under Law 14.874/24 and RDC 837/2023. CEP reviews scientific merit, risk-benefit, consent, and investigator fit. It does not apply a rigid GLP checklist. The same fact is restated on the live Brazil clinical-trials hub. ANVISA’s open-data directory at dados.anvisa.gov.br/dados/ publishes device-queue metrics and the registered produto-para-saúde catalog. It does not publish a device-trial registry. Do not invent one. Device clinical investigations (DICD) are petitioned; they are not an open trial list.
• Panama. Ethics-committee-driven through the Comité Nacional de Bioética de Investigación (CNBI) and the institutional committee. R&D-grade data is accepted with an ISO 14971 file and an investigator’s brochure. ISO 13485 certification is not required for an investigational early-feasibility device; fitness-for-use documentation is enough. Country detail, including Decreto 21, sits on the Panama preclinical page and the Panama FIH guide. RESEGIS is the public health-research list (listprojects) — mixed protocols, not devices-only.
• El Salvador. The same live GLP guide: the early-feasibility path does not require GLP-compliant preclinical data. Ethics committees evaluate the totality of the evidence — biocompatibility, mechanical performance, safety margins — against the proposed risk-benefit and the patient population. The current agency is the Superintendencia de Regulación Sanitaria (SRS), srs.gob.sv. Dirección Nacional de Medicamentos (DNM) is the older name. SRS’s public servicios page lists a device expediente and a clinical-trial submission platform. There is no public approved-protocol list. Do not claim one.

That published comparison also records what those three countries accept for the investigational unit itself: no ISO 13485 certificate as a hard early-feasibility gate, and verified (batch-level) sterility instead of a fully validated commercial sterilization process. Hospital infection-control review is often the real sterility gate. This page does not reopen that manufacturing argument; the GLP guide already holds it.

Colombia — INVIMA is a national-authority file, not a test menu

Colombia routes novel high-risk device investigations through INVIMA. The live GLP guide treats INVIMA as case-by-case and slower for truly novel devices without predicates (typical published clock 8–14 months). That is a pathway fact, not a preclinical quota.

What INVIMA does publish is a device-study inventory, not a required animal or GLP list. The official attachments under INVIMA investigación clínica de dispositivos médicos include the approved-study PDF (2021–October 2025) and the not-approved PDF for the same window. Those tables name acta, radicado, protocol title, investigational product, sponsor, CRO, ethics committee, site, and PI. They do not name a required n, species, duration, or Part 58 stamp. INVIMA’s public /estudios consulta is a medicine-trial search. Do not treat it as a device-trial dump.

The published “how much” example already on the FDA-acceptance FIH guide is the ReGelTec HYDRAFIL package that INVIMA and the independent ethics committee accepted: a 12-study GLP-where-applicable biocompatibility file compiled into a Biocompatibility Summary Report (ISO 10993 series, genotoxicity, chemical characterization and risk assessment). The same FIH guide says Latin American authorities do not prescribe a specific list of preclinical tests. The burden is on the sponsor to show the device is safe for first-in-human use. That published package is one accepted file. It is not a mandate for every Colombia or Latin America FIH.

Chile — official guidance, no public device-trial list

Use the May 2026 ANDIM guide above for the Chilean preclinical posture. ANDIM’s own home page, ispch.gob.cl/andim, still labels the studies platform “Plataforma de Estudios Próximamente.” There is no public Chilean device-trial registry to scrape. The medicine consulta at estudiosclinicos.ispch.gob.cl is not a device list. ISO 10993 appears in the official bibliography as Chilean NCh adoptions (NCh 2856/3 and NCh 2856/10) — genotoxicity / carcinogenicity / reproductive toxicity, and irritation / delayed hypersensitivity — not as a required animal n.

Mexico and Argentina — do not invent a device-trial preclinical menu

COFEPRIS public visors (medicines and the devices visor) are registro-sanitario search pages. They are not a first-in-human preclinical checklist and not a trial registry.

ANMAT’s downloadable estudios de farmacología clínica workbook is medicines. It is not a device-trial dump. This page does not invent a COFEPRIS or ANMAT device-FIH animal rule from those surfaces.

Public bioaccess® files already on the site

Reuse only what is already public:

• ReGelTec HYDRAFIL — out-of-U.S. first-in-human work in Colombia and Panama (75 patients) later used toward CE Mark and an FDA IDE. Clinical-execution history. The preclinical package accepted by INVIMA is the 12-study GLP-where-applicable biocompatibility file on the FIH guide, not a large-animal quota for every device.
• Axoft’s first-in-human brain-computer interface implantation in Panama, as already written on the Panama FIH guide: a novel device with no predicate, no prior human data, and R&D-grade preclinical testing. The ethics-committee path evaluated the risk-benefit narrative — investigator, monitoring, patient selection — rather than a GLP certification that did not yet exist for that device category.
• Newrotex’s 15-day ethical approval in Panama for a first-in-human silk nerve guide, as already written on the FDA-acceptance FIH guide.
• enVVeno’s early first-in-human clinical work in Latin America, as already written on the same FIH guide. The later FDA IDE is for a U.S. pivotal study; it is not a device clearance.

What to put in the investigator’s brochure

From the live early-feasibility guide, ethics committees in the recommended jurisdictions typically look for:

• ISO 10993 biocompatibility that is scientifically valid — not necessarily GLP-wrapped
• Mechanical and functional bench data
• Sterilization verification (batch-level / verified sterility is accepted for early feasibility; include packaging-integrity and sterile-barrier evidence)
• An ISO 14971 risk file
• An investigator’s brochure that documents all available safety information
• A written plan for which studies you will later repeat under GLP if the file is going to FDA

For implants, the same guide names endotoxin testing (LAL or rFC; USP <85> / ISO 11737-1). This page still does not prescribe a required n, species, or duration.

FDA later is a different question

Whether a Latin America first-in-human file later supports an FDA IDE, 510(k), De Novo, PMA, or HDE is a 21 CFR § 812.28 question, not the Latin America start gate. The short answer is on does FDA accept LATAM clinical data. The long answer, including the typical testing frame (not a statute) and the ReGelTec package, is the FDA-acceptance FIH guide. ISO 14155 is the device GCP bridge. A Latin America ethics letter is not an FDA clearance prediction.

Build the brochure and the trial master file as if an inspector will ask for them. That is how you keep the Latin America FIH usable later. It is not how Brazil, Panama, or El Salvador decide whether you may start.

Related bioaccess® pages

• Panama cut — how much animal / preclinical data for a Panama FIH
• Which LATAM countries accept R&D-grade preclinical data, non-GMP devices, and verified sterility
• Will FDA accept a Latin America FIH study, and what does the typical preclinical frame look like
• Why Panama is used for first-in-human device studies
• Short answer: does FDA accept LATAM clinical data?
• First-in-human study basics
• Brazil clinical-trials hub
• ReGelTec case study

Official government sources cited

• Chile ANDIM, May 2026 — Guía de Investigación Clínica de Dispositivos Médicos en Humanos
• Chile ANDIM guides index — guías técnicas; ANDIM home — ispch.gob.cl/andim
• Panama Decreto Ejecutivo No. 21 of 23 April 2026 — official PDF
• MINSA regulación de investigación para la salud (Ley 84 of 14 May 2019; Decreto 21) — minsa.gob.pa
• Panama RESEGIS public list — listprojects
• INVIMA device-trial attachments — investigación clínica de dispositivos médicos
• ANVISA open data (no device-trial registry) — dados.anvisa.gov.br/dados/
• El Salvador SRS servicios — srs.gob.sv/?p=1770

If you are planning a Latin America first-in-human or early-feasibility device study, send bioaccess® the investigator’s brochure and the risk file. We will tell you whether the narrative is complete enough for the ethics committee and, where it applies, the national authority — or where the gaps are — without inventing an animal quota the official texts do not write.

Panama does not publish a required animal n, a required species list, or a 21 CFR Part 58 GLP stamp as a hard first-in-human gate. MINSA and the ethics committees look for a coherent risk-benefit case: enough bench, biocompatibility, and (when the device needs it) animal data to justify a small, monitored medical-device study, written into an ISO 14971 file and an investigator’s brochure.

That is the operator answer bioaccess® already gives when a sponsor asks “how much animal data for a Panama FIH?” The longer GLP and FIH guides already say it. They bury it. This page is the dedicated send.

What Panama actually reviews

For investigational device studies — especially early feasibility and first-in-human — Panama uses an ethics-committee-driven pathway. The Comité Nacional de Bioética de Investigación (CNBI) and the institutional ethics committee are the primary decision-makers. There is no separate national device-authority checklist of the kind you get from INVIMA or ANVISA.

CNBI review, as already published on the Panama FIH guide, includes scientific merit, risk-benefit and consent, investigator and site fit, patient-protection measures — and preclinical-data sufficiency evaluated as a coherent safety narrative, not a GLP checklist.

The early-feasibility guide is explicit: Brazil, Panama, and El Salvador accept R&D-grade (non-GLP) preclinical data for early feasibility device studies. In Panama that file is accepted when it is supported by an ISO 14971 risk-management file and an investigator’s brochure that records the safety information you actually have. Ethics committees want a plan for which studies you will later repeat under GLP if you are building an FDA file. They are not asking whether every test already carries a Part 58 stamp.

ISO 13485 certification is not required for an investigational early-feasibility device in Panama. Fitness-for-use documentation is enough: ISO 14971, lot traceability, functional verification, basic safety, and the brochure.

Decreto 21 of 2026 did not add an animal quota

The current clinical-research rulebook is Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C). It implements Titles III and IV of Ley 84 of 14 May 2019. The public Panama hub already names what that decree switched on: accredited Type II committees for clinical trials, RESEGIS registration, and parallel MINSA + ethics review for high-risk protocols.

Sponsors still file a Spanish package: protocol, investigator’s brochure, informed consent, and insurance. MINSA oversees investigations through the Dirección Nacional de Farmacia y Drogas. Ethics review runs through institutional bioethics committees registered with CNBI.

None of that published rulebook sets a required animal n, species, or duration. Do not read Decreto 21 as a hidden GLP animal mandate.

A typical degenerative-disc frame — not a mandate

The public first-in-human testing guide lists a typical preclinical frame that includes small-animal (rodent) proof-of-concept and large-animal models (porcine or ovine spine models) with functional outcomes, histology, and imaging correlation. Treat that as a frame for a degenerative-disc or injectable-hydrogel program, not as a Panama statute and not as a required n for your device.

If your device is not a spine injectable, do not copy that frame by habit. The ethics question stays the same: is this device safe enough for a controlled feasibility study in a small cohort with consent and monitoring?

Public precedent already on the site

The same first-in-human guide publishes the ReGelTec HYDRAFIL package that INVIMA and the independent ethics committee accepted for a first-in-human file in this device space: a 12-study GLP-where-applicable biocompatibility file compiled into a Biocompatibility Summary Report (ISO 10993 series, genotoxicity, chemical characterization and risk assessment). Latin American authorities, the page says, do not prescribe a specific list of preclinical tests. The burden is on the sponsor to show the device is safe for first-in-human use.

That published “how much” example is a GLP biocompatibility battery. It is not a mandated large-animal efficacy study for every Panama FIH. Panama’s own FIH FAQ still says R&D-grade (non-GLP) data is accepted with an ISO 14971 file and an investigator’s brochure.

The public ReGelTec case study already on bioaccessla.com records the out-of-U.S. first-in-human program across Colombia and Panama (75 patients), later used to support CE Mark and an FDA IDE. That is clinical-execution history, not a preclinical checklist.

The Panama FIH guide also records a different public case: the Axoft brain-computer interface first-in-human implantation in Panama, a novel device with no predicate, no prior human data, and R&D-grade preclinical testing. The ethics-committee pathway evaluated the risk-benefit narrative — investigator, monitoring, patient selection — rather than demanding a GLP certification that did not yet exist for that device category.

What to put in the investigator’s brochure

From the early-feasibility guide, ethics committees in the recommended jurisdictions typically look for:

• ISO 10993 biocompatibility that is scientifically valid — not necessarily GLP-wrapped
• Mechanical and functional bench data
• Sterilization verification (batch-level / verified sterility is accepted for early feasibility; include packaging-integrity and sterile-barrier evidence)
• An ISO 14971 risk file
• An investigator’s brochure that documents all available safety information
• A written plan for which studies you will later repeat under GLP if the file is going to FDA

For implants, the same guide also names endotoxin testing (LAL or rFC; USP <85> / ISO 11737-1). Hospital infection-control review is often the real sterility gate, not a national animal-study rule.

This page does not prescribe a required n, species, or duration for a named device. Device class, contact duration, and the specific ethics committee still decide.

If you need the Panama data for FDA later

FDA acceptance of a Latin America device investigation is a separate question from the Panama gate. Under 21 CFR § 812.28, FDA may accept foreign clinical data for an IDE, 510(k), De Novo, PMA, or HDE when the study was conducted under GCP, reviewed by an independent ethics committee, and used a device identical — or adequately compared — to the U.S. article. ISO 14155 is the device GCP bridge FDA has publicly recognized. A Panama ethics letter is not an FDA clearance prediction.

Build the investigator’s brochure and the trial master file as if an inspector will ask for them. That is how you keep the Panama FIH usable later. It is not how Panama decides whether you may start.

FAQs from RAQA teams

These are the three questions we get most often when a regulatory-affairs and quality-assurance lead reviews the Panama FIH pathway for a spinal or orthopedic device. Direct answers with the sources already cited above.

Q1. Are functional large-animal studies required for a first-in-human medical-device study in Panama?

No — not as a hard, across-the-board requirement of MINSA (Ministerio de Salud, Panama’s Ministry of Health). Decreto Ejecutivo No. 21 of 23 April 2026, which implements Titles III and IV of Ley 84 of 14 May 2019, does not publish a required animal number, species, duration, or GLP mandate. When the device warrants it — because of its class, contact duration, or mechanism — animal data goes into the risk-benefit narrative that MINSA and the CNBI-accredited ethics committee review. It is a conditional element of a coherent safety case written into an ISO 14971 risk file and an investigator’s brochure, not a checklist item.

The rodent-plus-porcine/ovine spine model with functional outcomes, histology, and imaging correlation described earlier in this post is the typical preclinical frame for a degenerative-disc hydrogel injectable. Treat it as a frame for that class of device, not as a Panama statute.

Q2. Have Panama’s clinical-research regulations become more stringent since ReGelTec cleared its first-in-human file?

Not on the preclinical evidence side. ReGelTec’s Panama FIH cleared with a 12-study ISO 10993 biocompatibility battery (with GLP where applicable), genotoxicity, and chemical characterization — no large-animal efficacy study. Panama’s posture on non-GLP R&D-grade preclinical evidence supported by an ISO 14971 risk file has not shifted since.

What Decreto Ejecutivo 21 of 2026 changed is process, not preclinical evidence:

• RESEGIS (Registro de Investigaciones para la Salud, MINSA’s national research-registration platform) — clinical investigations now register through the platform.
• CNBI Type II committee accreditation — ethics review runs through a committee accredited by the Comité Nacional de Bioética de la Investigación (Panama’s national bioethics council).
• Parallel MINSA + ethics review for higher-risk protocols — the two tracks run in parallel rather than sequentially, which shortens elapsed time for well-prepared files.

The bar for what a sponsor must show has not risen. The plumbing around how it gets shown has been modernized.

Q3. What does an ethics committee actually decide, and how should a RAQA lead present the preclinical evidence?

The CNBI dictamen (the ethics committee’s formal opinion) is the anchor decision for early-feasibility and first-in-human device studies in Panama. It weighs:

• Scientific merit of the protocol
• Risk-benefit balance
• Informed consent
• Investigator and site suitability
• Patient-protection measures
• Sufficiency of preclinical data — evaluated as a coherent safety narrative, not as compliance with a fixed GLP checklist

Present the preclinical package as a narrative that ties bench evidence, biocompatibility, and (when the device needs it) animal evidence to the ISO 14971 risk file, the investigator’s brochure, and the small-cohort study design. Anchor sterilization and packaging to ISO 11607-1/2 and ASTM F88/F1886. If you plan to convert Panama clinical data into a later FDA submission under 21 CFR § 812.28, build the file to ISO 14155 GCP so that path stays open — that is a “later” question, not a “start” question. Panama does not decide FDA acceptance.

Related bioaccess® pages

• Why Panama is used for first-in-human device studies
• Which LATAM countries accept R&D-grade preclinical data, non-GMP devices, and verified sterility
• Will FDA accept a Latin America FIH study, and what does the typical preclinical frame look like
• Decreto 21 of 2026 — what sponsors need to know
• Short answer: does FDA accept LATAM clinical data?
• First-in-human study basics

If you are planning a Panama first-in-human device study, send bioaccess® the investigator’s brochure and the risk file. We will tell you whether the narrative is complete enough for CNBI and the institutional committee, or where the gaps are, without inventing an animal quota the statute does not write.

Sponsors still put “Paraguay” on one regulatory Gantt. That is the mistake. A first-in-human (FIH) or early feasibility study (EFS) for a medical device in Paraguay runs as a DINAVISA clinical-investigation file plus an institutional ethics vote. Putting the same device on the Paraguayan market later is a DINAVISA sanitary-registration file. Same agency name. Different petition, different importer, different success criterion.

If the board slide says “DINAVISA approved,” ask which DINAVISA. Trial authorization is not a registro sanitario. Confusing them delays first patient and later stalls commercial import.

Two files, one agency

DINAVISA (Dirección Nacional de Vigilancia Sanitaria) is Paraguay’s sanitary authority. It authorizes clinical investigations for devices used in-country. Ethics sits with the site’s Comité de Ética en Investigación, not with a Miami PowerPoint. Those are sequential gates on the trial track, not a commercial license.

For a U.S. or European MedTech team, the practical split looks like this:

• Trial file: protocol, investigator brochure, informed consent in Spanish, institutional ethics package, investigational labeling, ISO 14155 monitoring plan, and the import story for units that will only be used in the study.
• Registro file: sanitary registration for manufacture, import, storage, distribution, and promotion of a commercial device, with a Paraguayan party DINAVISA will treat as responsible for that certificate — not a PI’s clinic stamp and not a named hospital that happens to have run FIH.

Public first-in-human sites in Asunción are sites. They are not the CRO and they are not the commercial titular. Do not treat a surgeon’s name as the DINAVISA commercial file.

What FDA reviewers will ask later

If the Paraguay FIH is meant to support a U.S. IDE or marketing file, design the investigation so the evidence room can satisfy 21 CFR § 812.28 (acceptance of data from clinical investigations conducted outside the United States). That regulation expects GCP, independent ethics review, and a device comparable to the version you will put in front of FDA.

ISO 14155 is the device GCP bridge FDA has publicly recognized for foreign investigations. A clean DINAVISA investigation letter does not replace an inspectable trial master file. Keep device accountability, deviation logs, monitoring reports, and the ethics correspondence in one place from day one. Eligibility of foreign data is not a clearance prediction.

Ethics-committee median timelines on bioaccess®’s Paraguay page are in the 4–6 week band. That is ethics, not DINAVISA commercial registro, and not a promise of first-patient week. Do not put a single “Paraguay clock” on the Gantt.

Import: investigational units are not the registro SKU

A commercial DINAVISA registration number does not clear investigational kits. Do not put a cousin SKU’s registro on the airway bill “because the PI knows customs.” Name the trial importer before ethics stamps the protocol. Map every investigational model, accessory, and spare to the investigation-authorized list. Outer labels must read as investigational, with lot or serial traceability that matches the accountability log at the site.

After last patient, close investigational inventory under the trial rules. Leaving units “for the hospital” without a new sanitary path is a new regulatory event, not a courtesy.

Holder vs distributor (commercial track only)

When you later want Paraguayan market access, DINAVISA will look for a local face on the sanitary registration: renewals, variations, labeling, and tecnovigilancia. A distributor who only sells stock is not automatically that holder. If the holder relationship breaks, the registro does not quietly follow the freight forwarder — you re-file.

That commercial conversation belongs on a separate workstream from the investigation calendar. Running them as one “Paraguay regulatory” workstream is how teams discover, mid-enrollment, that nobody can import the commercial launch SKU.

One-page gate before first patient in Paraguay

Write these lines with owners and document IDs before you book site initiation:

1. Authority map. DINAVISA investigation plus institutional ethics for the study. DINAVISA registro only if a parallel commercial file is truly in scope this year.
2. Ethics + investigation sequence. Same protocol version and the same Spanish informed-consent text in both packages.
3. Investigational importer. Legal name and the document that ties the shipment to the investigation authorization — not a commercial registro number.
4. Device list. Every unit that will sit in the site accountability log, including accessories.
5. ISO 14155 file owner. Who can produce monitoring, accountability, and ethics letters within 48 hours if FDA or a notified body asks.
6. Commercial holder (optional, separate). If launch is real, name the DINAVISA titular and keep that file off the FIH critical path until first patient is locked.

Where teams burn weeks

Three patterns show up repeatedly on Paraguay device files:

• PI as importer. Naming the investigator as the consignee because “he runs the lab.” Unless that person is the licensed trial importer under the investigation authorization, sanitary inspection will not treat the airway bill as study supply.
• Registro number on investigational freight. Using a commercial DINAVISA certificate for a predicate or related model to move FIH units. The investigational article is not that registered product.
• One Spanish translation for both desks. The informed-consent and brochure language for ethics and the investigation is not the commercial IFU DINAVISA will later lock. Mixing them creates labeling debt on both tracks.

Fix the patterns on paper before translators start. Re-translation after first patient is a protocol amendment problem, not a word-processing problem.

Practical next step

This week, split the Paraguay slide into two columns: DINAVISA investigation and DINAVISA registro. If the same person owns both without two dossiers, two importers, and two success criteria, you do not have a Paraguay plan — you have a hope. bioaccess® runs FIH/EFS execution across Latin America, including Paraguay, and holds LATAM registration/IOR work as a separate market-access track; treat Paraguay the same way inside your own team.