Category: First-in-Human

Sponsors mix two Chile clocks into one bar labeled “ISP.” One clock is Instituto de Salud Pública (ISP) authorization for a medical-device clinical investigation and investigational import. The other is commercial sanitary registration under Chile’s expanding Exempt Decree No. 25 wave. They are not the same petition. Confusing them is how a Santiago FIH plan quietly becomes a 2028 market-access scramble.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is the operator brief for running a medical-device clinical trial in Chile under ISP — and keeping that trial file off the commercial registro track. It is grounded in the live FIH startup clock, fast-track FIH corridor, Chile Exempt Decree No. 25 / ISP registration 2028, and Chile site posts such as Hospital Luis Tisné Santiago. It is not a quote and not legal advice. Confirm current ISP, ethics, and import instructions before you file.

Two Chile files — write them apart first

1. Investigation file (this page). ISP authorizes the clinical investigation and investigational-device import. An Ethical-Scientific Committee under Law 20.120 still has to sit. Success criterion: authorized research use of the named investigational article at named sites.
2. Commercial registro file (different Gantt). Exempt Decree No. 25 (published 19 March 2026) expands mandatory ISP sanitary registration across 39 product types, including software as a medical device and multiple IVDs, with transition waves toward 2028/2029. Success criterion: conformity verification / ISP sanitary registration for manufacture, import, marketing, or distribution of covered products after the applicable transition dates.

Live Chile blogs already put a typical ISP investigation review in a band of about 30 business days. Commercial ISP registration in a 30–90 day band is a different file. Do not put both on one Gantt labeled “Chile.”

Where Chile sits on the FIH map

Chile is inside Latin America’s fast-track FIH corridor with Panama, El Salvador, and Costa Rica. Published corridor activation band: 15–45 days. Panama remains the documented extreme (~15-day activation; ethics-submission ID in about 3 business days). Chile’s published role in that corridor is different: corridor speed plus top-tier perceived data rigor — the combination sponsors look for when they do not want a “small fast market” discount on the evidence package.

Speed drivers on the live corridor page: efficient ethics and ISP pathways; experienced committees. Cost tier: upper among corridor countries — you pay for depth and perception. Population is still small; feasibility and backup sites matter.

What ISP owns on the trial track

• Clinical-investigation authorization. ISP is the investigation desk for device studies in Chile. A named hospital campus on ClinicalTrials.gov is not the ISP applicant and is not the operator of the ISP file.
• Investigational-device import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See the regional investigational import guide.
• Not commercial registro. Post-Decree 25 market access (technical instruction from ISP within up to 12 months of publication, Spanish IFU/label expectations, tecnovigilancia enrollment) belongs on the commercial track. Keep it off the FIH critical path until first patient is locked.

We will not invent PAHO/WHO Level 4 standing for ISP. All bioaccess® device protocols in this country run under ISO 14155 and the Declaration of Helsinki.

Ethics under Law 20.120

An Ethical-Scientific Committee under Law 20.120 still has to sit. Institutional ethics calendars at Chilean hospitals are real — and they are not ISP. Share committee calendars and hospital research rules with the CRO early. Do not wait for the ISP letter to discover that the committee meets monthly and your Spanish informed-consent text is still in draft.

Operator rule: same protocol version and same Spanish informed-consent text across the ethics packet and the ISP packet. The commercial IFU you will later lock under Decree 25 is not the ethics ICF.

Submission checklist (investigation dossier)

Assemble the universal FIH core once, then layer Chile. Do not invent form codes that are not on live bioaccessla.com pages — use this operator checklist against ISP’s current published requirements at filing time.

Import: investigational units are not the Decree 25 SKU

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. 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.

Hand-carry is not the plan. Formal, traceable importation tied to the trial authorization is required across Latin America; Chile is not an exception.

If the Chile FIH must support a U.S. 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): 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. A clean ISP investigation letter does not replace an inspectable trial master file. Eligibility of foreign data under § 812.28 is not a clearance prediction. See the live 812.28 LATAM inspectability page.

Do not smear the hospital — and do not skip ISP

Named Santiago campuses on ClinicalTrials.gov (for example Hospital Luis Tisné, Clínica Colonial) are real hospital strings. They can discuss investigator interest, local visit costs, and ethics calendars. They cannot, by ranking on ClinicalTrials.gov, become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR § 812.28 packager. The First-in-Human CRO still owns those workstreams — plus the option to add another Latin American country if one Chilean campus is not the only enrollment fit.

Common rejection / delay patterns

• One “ISP” bar for trial and registro. Investigation (~30 business days planning) versus commercial registration (30–90 days planning; Decree 25 waves later) are different files.
• Commercial certificate on investigational freight. Decree 25 / sanitary registration paperwork does not clear FIH kits.
• Hospital NCT string treated as the regulatory plan. Campus ≠ ISP file.
• Importer named after first patient. Import then becomes the critical path.
• Waiting for ISP’s Decree 25 technical instruction before any commercial readiness. That is a market-access problem — keep it off the FIH critical path, but do not ignore it for launch planning.

One-page gate before first patient in Chile

• Authority map: ISP investigation + Ethical-Scientific Committee (Law 20.120) versus commercial ISP registro under Exempt Decree No. 25 only if launch is truly in scope.
• Same protocol version and same Spanish informed-consent text across ethics and ISP packages.
• Investigational importer named, with the document that ties the shipment to the investigation authorization.
• Device list complete, including accessories.
• ISO 14155 file owner who can produce monitoring, accountability, and ethics letters within 48 hours if FDA asks.
• Feasibility: real site-level patient flow for your indication — corridor speed does not create patients.

Related reading on bioaccessla.com

• Chile’s easy market ends in 2028: Exempt Decree No. 25 and ISP registration
• FIH Latin America startup clock
• Panama, El Salvador, Chile, Costa Rica: fast-track FIH corridor
• Importing investigational devices into Latin America
• Hospital Luis Tisné Santiago: NCT campus ≠ ISP file
• FDA 21 CFR 812.28 in LATAM
• Independent sanitary registration holder strategy
• Medical device registration & market access

Planning a Chile FIH file — ISP investigation, Law 20.120 ethics, and investigational import kept off the Decree 25 registro track? Talk with bioaccess® — contact Julio Martinez-Clark at jmclark@bioaccessla.com or +1 (954) 903-7210.

Sponsors keep asking one stacked question: how do I obtain ANVISA, COFEPRIS, ANMAT, or Panama MINSA approval for a medical device clinical trial? Those four names are not interchangeable stamps. Each one is a different investigation desk, with a different ethics gate, and a different investigational-import story. Treating them as one “LATAM approval” is how a Gantt goes soft.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is a comparison hub for medical-device clinical-investigation authorization in Brazil, Mexico, Argentina, and Panama. It is grounded in live bioaccessla.com posts on the FIH startup clock, investigational import, ANMAT investigation checklist, Mexico’s COFEPRIS reset, and the Panama / El Salvador corridor pages. It is not a quote and not legal advice. Confirm every instrument against each agency’s current published texts before you file.

Write four columns before translators start

Put these four tracks on one page. Do not merge them into a single “regulatory” bar.

1. Brazil — ANVISA. Agency review of the device clinical investigation, plus ethics (CEP/CONEP), plus a two-layer import path.
2. Mexico — COFEPRIS. Federal protocol authorization, plus CONBIOÉTICA-linked ethics, plus a research-use import permit.
3. Argentina — ANMAT. Investigation authorization (not commercial registro), plus independent ethics, plus provincial filings where required.
4. Panama — MINSA. Ministry of Health investigation track with CNBI-registered ethics — the documented sprinter in the fast corridor.

If the board slide says “we got LATAM approval,” ask which desk, which ethics letter, and which import document.

Same question, four different clocks

Published operator planning bands on the live startup clock (confirm at contracting):

Panama sits with Chile, El Salvador, and Costa Rica in the 15–45 day corridor. Mexico, Brazil, Colombia, and Argentina sit in the major-market band unless a measured clock proves otherwise.

Brazil — ANVISA (investigation + import are two layers)

For investigational devices, Brazil is a two-layer system on the live import guide:

• ANVISA clinical-investigation approval under RDC 837/2023. The Comunicado Especial lists the investigational products and authorized quantities.
• Licença de Importação (LI) in Siscomex with ANVISA release at the port. The import rulebook (RDC 81/2008) is under revision — confirm the current instrument before citing it at filing.

Ethics runs through CEP/CONEP. Portuguese certificate-of-insurance language is not optional stationery for that packet. Use the Brazil clinical-trials hub for clocks; do not invent medians here.

Operator check: freeze the investigational product list once. The Comunicado Especial quantities must match what Siscomex will see. A commercial sanitary registration number does not clear FIH freight.

Mexico — COFEPRIS (reset language ≠ measured clock yet)

COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is Mexico’s federal health regulator. CONBIOÉTICA is the national bioethics commission. Live COFEPRIS reset coverage already states:

• Published direction cuts clinical-trial protocol review from ~120 days toward ~30 days.
• An abbreviated pathway in force since 1 September 2025 gives ~30-business-day device decisions for products already authorized by certain reference regulators.
• A 15 January 2026 decree amended the Ley General de Salud on clinical-research reform, with COFEPRIS–CONBIOÉTICA coordination.
• Regulatory reliance language recognizes evaluations by FDA, EMA, MHRA, and Health Canada for clinical-research protocols.
• Ethics / IRB review remains a separate ~4–6 week benchmark clock.

Import: a research-use import permit connected to the COFEPRIS trial authorization. Confirm the current COFEPRIS procedure at filing — agency processes have been changing.

Until sponsors and CROs have measured real-world clocks across several submissions, keep Mexico on the watchlist with an asterisk. Parallelize ethics and regulator filings; do not bank the announcement as Panama-class speed.

Argentina — ANMAT (investigation is not registro)

ANMAT is one agency name on two files. Write them apart before anyone translates:

1. Investigation file. Clinical-investigation authorization for FIH or early feasibility, plus independent ethics under ISO 14155 and the Declaration of Helsinki, plus provincial oversight where required (for example Buenos Aires). Disposición ANMAT 7516/2025 Article 5 assigns clinical-investigation evaluation to the Dirección de Investigación Clínica. Published planning framework: 90-business-day statutory review target that pauses for RFIs.
2. Registro file. Sanitary registration for Classes I–IV under Disposición ANMAT N° 64/2025, including HELENA declaración jurada routes for eligible CE-marked Class I/II. Success criterion: a selling license — not a trial letter.

Import authorization links to the ANMAT trial approval through a licensed importer of record. Argentina’s import documentation is exacting. Reconcile every document before filing. A HELENA DDJJ or a cousin SKU’s registro does not move investigational kits.

Full dossier checklist: see the live ANMAT clinical-trial submission checklist.

Panama — MINSA (fast corridor, still two files)

Panama’s Ministry of Health (MINSA) oversees clinical investigations through the Dirección Nacional de Farmacia y Drogas on the live Panama hub language. Ethics review runs through institutional bioethics committees registered with the national CNBI. Published ethics band: about 3–5 weeks. Insurance exhibits belong in that packet.

Published Class III FIH geography language points at Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 on the Panama Class III FIH guide — confirm those instruments at filing. Dollarized economy, English-capable sites, investigation units only.

Import authorization is tied to the MINSA trial authorization. Panama’s fast startup clock only holds if import runs in parallel with ethics and regulatory submissions. Commercial registro stays a separate MINSA market-access file.

Universal dossier core (assemble once)

Use the same core across all four desks, then layer country packets. Grounded in the live LATAM FIH submission-package checklist:

How these approvals relate to FDA

A clean ANVISA, COFEPRIS, ANMAT, or MINSA investigation letter does not replace an inspectable trial master file. Foreign clinical data can be eligible for FDA submission and review under 21 CFR § 812.28 when the investigation meets the GCP conditions in that rule. ISO 14155 is the device GCP bridge FDA has publicly recognized for foreign investigations. Eligibility is not a clearance prediction. Keep device accountability, deviation logs, monitoring reports, and ethics correspondence in one place from day one. See the live FDA 21 CFR 812.28 LATAM inspectability and FDA acceptance of LATAM FIH data pages.

Common failure patterns across all four

• One LATAM Gantt bar. Panama’s corridor clock does not transfer to ANVISA or ANMAT.
• Registro number on investigational freight. Commercial certificates do not clear FIH kits in Brazil, Mexico, Argentina, or Panama.
• Ethics after agency. Sequential filing burns calendar the statutory targets never promised to absorb.
• Importer named after first patient. Import then becomes the critical path ethics cannot fix.
• Announcement clocks treated as measured clocks. Especially Mexico’s COFEPRIS reset — verify before you promise the board.

One-page gate before first patient

• Country shortlist with indication-level patient flow — not just the fastest desk.
• Authority map: investigation desk + ethics (+ provincial / CONEP / CNBI as applicable) versus commercial registro on a separate track.
• Same protocol version across every packet.
• Importer named, with the document that ties shipment to investigation authorization.
• Device list complete, including accessories and authorized quantities.
• ISO 14155 file owner who can produce monitoring, accountability, and ethics letters within 48 hours if FDA asks.

Related reading on bioaccessla.com

• How long does it take to start a FIH trial in Latin America?
• Importing investigational devices into Latin America
• ANMAT clinical-trial submission checklist
• ANMAT trial authorization vs registro
• Mexico’s COFEPRIS reset for FIH sponsors
• Panama or El Salvador FIH cost vs the US
• Clinical trial insurance in Latin America
• Universal LATAM FIH submission package
• Medical device registration & market access

Planning a multi-country FIH file across Brazil, Mexico, Argentina, or Panama? Talk with bioaccess® about sequencing investigation desks, ethics, and investigational import — contact Julio Martinez-Clark at jmclark@bioaccessla.com or +1 (954) 903-7210.

Sponsors keep asking how to get IRB approval for a medical device study in Colombia as if ethics were a single stamp that also clears INVIMA. It is not. In Colombia the ethics desk is a Comité de Ética en Investigación (CEI) approved by INVIMA, sitting at an IPS that holds a current Buenas Prácticas Clínicas (BPC) certificate. The investigation opinion and the import authorization are separate desks. Mixing them is how first patient slips a cycle.

I am Julio Martinez-Clark, CEO of bioaccess®. This is the Colombia ethics walkthrough for medical-device studies, grounded in the live Colombia clinical-trial execution pillar, the INVIMA clinical-trial submission checklist, and the universal LATAM FIH submission package. It is not a quote and not legal advice. Confirm every form against INVIMA’s current Investigación Clínica — Dispositivos page before you file.

What “IRB” means in Colombia

US sponsors say IRB. In Colombia the working term is CEI — an INVIMA-approved research ethics committee. The CEI reviews the protocol, informed consent, and investigator packet under the human-subjects rules in Resolución 8430 de 1993. The CEI letter is not an INVIMA investigation opinion, and it is not a Registro Sanitario.

Write three owners before you open a Spanish translation folder:

1. CEI / ethics. INVIMA-approved committee; initial study evaluation on form ASS-RSA-FM169.
2. INVIMA investigation opinion. For devices, the Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV), supported since 20 September 2022 by the GICASE group under Resolución 2022035262. Forms ASS-RSA-FM085 / ASS-RSA-FM172.
3. Import of the investigational article. Exceptional importation under Decreto 4725 de 2005 Article 48(b), against a prior specialized-chamber opinion — not a commercial registro number on the airway bill.

If your Gantt has one bar labeled “Colombia IRB,” you do not have an ethics plan. You have a hope.

Site prerequisites the CEI will not waive

A Colombian interventional device study needs more than a friendly PI:

• A CEI approved by INVIMA.
• A site (IPS) with a current BPC certificate. INVIMA issues that certificate after verifying compliance with Resolución 2378 de 2008 through inspection visits. The certificate runs five years.
• Evidence that the institution is registered under the Sistema Único de Habilitación with authorized pharmaceutical service, clinical laboratory, and sample-collection services inside the same habilitación. Contracting those services outside the habilitación adds documentation to every BPC modification.

INVIMA’s register of approved research ethics committees places them in Bogotá, Medellín, Cali, Floridablanca, and Montería, attached to established IPS and medical foundations. Bogotá, Medellín, and Cali remain the tier-1 clusters for most device programs. Replacing a site’s ethics committee is a formal BPC modification: a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO, and both committees. Treat CEI selection as a critical-path item, not an afterthought.

Step-by-step: ethics before (or beside) the INVIMA file

Colombia is not Panama’s parallel Type II + MINSA corridor. Plan CEI, INVIMA concept, and import as sequential critical-path items unless your operator has a documented reason to overlap them. The measured INVIMA average footed on the Colombia execution pillar is 5.1 months to a definitive concept (approve or reject). There is no statutory day-count for that concept. Do not paste a fast-corridor ethics band onto Bogotá.

1. Freeze the protocol version that every desk will see. The universal FIH core already names protocol, investigator’s brochure, informed consent, case report form, insurance, and preclinical testing. Colombia’s country add-on is a procedure-risk matrix — procedural risk, not FDA-style design verification.
2. Pick the IPS and confirm BPC + CEI status on INVIMA’s published registers before contracting. Do not discover a lapsed BPC certificate after the consent is translated.
3. Draft Colombian informed consent for that CEI — regulatory Spanish adapted for the committee, not a U.S. IRB form with a machine translation stapled on.
4. File the CEI package with ASS-RSA-FM169 (initial study evaluation completed by the ethics committee) and the reconciled Spanish + English pack: protocol, IB/preclinical, risk management (ISO 14971) appropriate to class, IFU and investigator training, clinical-trial insurance covering Colombian subjects, investigator CVs and GCP certificates, site budgets and contracts running in parallel so activation is not the bottleneck after the opinion lands.
5. Keep the CEI letter and the SEDMRDIV file on the same investigation story. Stopping rules, device description, and the article you will import must match. Prototype authorization under Decreto 4725 de 2005 Article 36 is research and experimentation only — not health care use, not a commercial registro number.
6. Only then treat import as its own authorization under Article 48(b). The CEI stamp does not clear customs.

What the CEI packet must prove

Timelines you can put on a board slide

• CEI cadence — committee-specific. Confirm meeting frequency during site selection. This page does not invent a national CEI day-count.
• INVIMA concept — measured average 5.1 months to a definitive concept; no statutory clock. Published approval and non-approval registers exist for device studies — read the non-approval register before you invent a “Colombia is unpredictable” narrative.
• Import — after the specialized-chamber path that Article 48(b) requires. Plan it as its own bar.
• Not law yet — the clinical-research framework bill filed in the Cámara in August 2025 would introduce tacit approval (7 calendar days common-risk / 30 high-risk, with FIH and novel implantables as high-risk). Do not put that clock in a diligence deck as if it were current INVIMA practice.

Common mistakes that burn ethics weeks

• Treating CEI approval as if it were the INVIMA investigation opinion or Registro Sanitario.
• Skipping BPC / habilitación checks, then losing weeks on a BPC modification mid-startup.
• Filing a drug Protocolos en Línea path (tariffs 4070 / 4083) for a device SEDMRDIV file — wrong desk.
• Assuming post-trial access is mandatory in Colombia. It is not. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no statutory post-trial supply duty; see the LATAM PTA operator map.
• One workstream for FIH evidence and later commercial registro. Article 18(k) of Decreto 4725 de 2005 is why class IIb and III evidence and registration strategy belong in the same plan — not why they share one ethics form.

Related reading on bioaccessla.com

• Clinical trial execution in Colombia
• INVIMA clinical-trial submission checklist
• How to run a first-in-human medical device trial in Colombia
• Ethics committees in Latin America: parallel vs sequential
• Universal LATAM FIH submission package
• CRO in Colombia · Colombia regulatory guide

Planning CEI plus INVIMA sequencing for a device study in Bogotá, Medellín, or Cali? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions, and 2–8 °C GDP cold chain across the region. Contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Frequently asked questions

How do I get IRB approval for a medical device study in Colombia?

Engage an INVIMA-approved CEI at an IPS with a current BPC certificate, file the ethics package (including ASS-RSA-FM169), and keep that packet aligned with the separate SEDMRDIV investigation file and Article 48(b) import path. The CEI letter alone does not authorize the study or the investigational shipment.

Is Colombia’s CEI the same as INVIMA authorization?

No. Ethics (CEI), INVIMA investigation opinion (SEDMRDIV / GICASE), and exceptional import are three desks under Decreto 4725 de 2005, Resolución 8430 de 1993, and the BPC regime in Resolución 2378 de 2008.

Which cities have INVIMA-approved ethics committees?

INVIMA’s published register places approved committees in Bogotá, Medellín, Cali, Floridablanca, and Montería. Tier-1 device work usually concentrates in Bogotá, Medellín, and Cali.

How long does Colombia ethics plus INVIMA take?

CEI timing is committee-specific. INVIMA’s measured average to a definitive concept is 5.1 months with no statutory day-count. Plan sequential desks unless you have a documented overlap plan.

Does every Colombian site need a BPC certificate?

Yes in practice for institutions running interventional research under INVIMA oversight. The certificate runs five years and depends on habilitación services inside the same institution.