cms.bioaccessla.com

Author: Julio Martinez-Clark

  • Chile’s Easy Market Ends in 2028: Exempt Decree No. 25 and ISP Registration

    Source: This article adapts and expands themes from Julio G. Martinez-Clark’s guest column on Med Device Online (published September 11, 2026): “Chile’s Easy Market Ends In 2028.” Read the full column there; what follows is an original bioaccess® operator brief for manufacturers building a Latin America (LATAM) market-access plan — not a reprint.

    For years, Chile was the LATAM medtech market where a strong distributor and an importer of record (IOR) could often move faster than a full sanitary-registration campaign. Only a short mandatory list — contraceptives, gloves, needles, and syringes — required Instituto de Salud Pública (ISP) registration for most commercial paths. In 2021 I asked on Med Device Online how long that “easiest market” window would last. Exempt Decree No. 25 answers it: the easy years run through 2026; the compressed years are 2027–2028.

    What changed: Exempt Decree No. 25

    On March 19, 2026, Chile published Exempt Decree No. 25 in the Diario Oficial (Núm. 44.404, CVE 2781436). The decree pulls 39 numbered medical device and in vitro diagnostic (IVD) types into the sanitary-control regime under Article 111 of the Health Code and Decree Supreme No. 825. ISP describes the set as higher-risk, widely used products tied to ministerial programs, with conformity verification based on quality, safety, and performance documentation.

    The legal machinery was already there — Decree Supreme No. 825 long required conformity-verification certificates for covered devices. Earlier exempt decrees had used that structure for narrow categories (for example sterile hypodermic needles and syringes). The difference now is scale: 39 types, including software as a medical device and multiple IVDs, phased into mandatory ISP sanitary registration.

    Two waves — and why the calendar is not the real clock

    First wave (24 months / 13 types in Artículo primero transitorio): deadline March 19, 2028. Includes cardiovascular implants and catheters, heart valves, cochlear implants, orthopedic and soft-tissue implants, copper intrauterine devices (IUDs), insulin infusion pumps and accessories, blood bags, and related numbered types in the decree.

    Second wave (36 months): deadline March 19, 2029. Includes imaging, radiotherapy, dialysis, ventilation, extracorporeal circulation, electrosurgical, ophthalmic, continuous glucose monitoring (CGM), continuous positive airway pressure / bilevel positive airway pressure (CPAP/BPAP), sterilization, oncology software, and several IVD categories.

    Seeing 2028 and assuming “plenty of time” is the first operational mistake. Decree No. 25 gives ISP up to 12 months from publication to issue the technical instruction for conformity verification. Voluntary filing is allowed only after that instruction exists. If the how-to lands near the 12-month mark, manufacturers in the first wave may have roughly one usable year — not two — to interpret requirements, assign ownership, assemble and translate files, close standards gaps, coordinate Chilean partners, submit, answer questions, and obtain registration. That is a compressed portfolio campaign, not a leisurely runway.

    Registration readiness now beats distributor-first strategy

    Chile’s older entry model made distributor selection the first strategic move. After the applicable transition dates, covered products may only be manufactured in Chile, imported, marketed, or distributed with the required conformity verification — which the decree frames as ISP sanitary registration. That shifts commercial leverage: if the distributor imports but nobody owns the Chile file, modification path, and continuity if the channel changes, you have built regulatory risk into the sales model.

    Treat this as a LATAM market-access problem, not a one-country paperwork chore. Many manufacturers still use Chile as an early regional entry point because of institutional stability and provider quality. When Chile stops being “import and sell,” the regional launch sequence changes. Map registration and portfolio triage before you lock distribution strategy. (For how bioaccess® packages market-access work, see the market-access rate card — without inventing case-specific rates here.)

    Do not confuse pathways. A clinical-trial authorization or investigational import route is a different file from commercial sanitary registration. It is not 2028 commercial cover. For Chile clinical-operations context, see our Chile clinical trials country page; keep investigational and commercial tracks separate in governance.

    Standards, Spanish dossiers, and postmarket (tecnovigilancia)

    Decree No. 25 points manufacturers toward an explicit standards-based review — including general references such as NCh ISO 16142 (parts 1 and 2), NCh ISO 13485, and NCh ISO 14971, plus product-specific standards for the 39 categories. Chile-ready work is a technical-file readiness exercise, not a local stamp.

    ISP guidance on essential principles of safety and performance already expects devices and IVDs to meet intended performance with risks acceptable relative to benefit, and to ship identification, safety, and use information in castellano (Spanish). Existing FDA, EU MDR, MDSAP, or ISO 13485 packs help — they are not automatically a Chile dossier. Family/group/system filings may not match Chile’s grouping expectations; labels and instructions for use (IFU) may need Spanish updates; legacy lines may have documentation gaps.

    Waiting for ISP’s technical instruction before doing any work wastes the only runway that matters. As of late August 2026 that instruction had not been issued. Final forms can wait; portfolio mapping, standards-gap assessment, Spanish labeling review, and local-role design cannot.

    Postmarket is part of the transition. ISP’s announcement on Decree No. 25 frames the reform as support for postmarket surveillance. Chile already operates tecnovigilancia (technovigilance) enrollment and adverse-event reporting expectations — including precise device identification (lot, model, series, manufacturer, intended use), not generic labels like “catheter” or “valve.” Traceability under related Chilean technical norms belongs in the same operating model as registration. Approval without a Chile-specific complaint, reporting, field-action, and file-sync plan is incomplete market access.

    Five triage moves manufacturers should make now

    1. Map the decree to the live Chile catalog — every model, accessory, software module, kit, and family currently sold, against scope and transition group.
    2. Rank by two-year commercial necessity — some legacy SKUs will not justify registration; platform anchors and consumables drivers often will.
    3. Assess technical-file readiness before the instruction drops — risk management, QMS certificates, Spanish labeling, accessory documentation.
    4. Define local responsibility — who files, maintains, modifies, answers ISP, and owns postmarket vigilance; “the distributor” is an answer only if it protects long-term flexibility.
    5. Budget a multiyear wave — governance, timelines, document owners, escalation — not a one-off filing event.

    What 2021 got right — and what the instruction gap changes

    Directionally, the 2021 Med Device Online column was right: Chile was not going to stay unusually open forever. The vehicle that landed is Decree No. 25 via the Ministry of Health and ISP (with ANDIM in the implementation picture), not the legislative script many watched at the time. Scope is larger than the old four-category mandatory list — 39 numbered types. The underweighted piece in 2021 was the instruction gap: a two-year transition looks generous until the agency has up to a year to write the how-to and early filing is gated on that how-to.

    Chile remains a serious, commercially attractive market with its own regulatory culture. What ended is the assumption that listed device types can enter without a sanitary-registration strategy. Map the catalog now.

    References

    1. Julio G. Martinez-Clark, “Chile’s Easy Market Ends In 2028,” Med Device Online, September 11, 2026 — https://www.meddeviceonline.com/doc/chile-s-easy-market-ends-in-0001
    2. Julio G. Martinez-Clark, “Medtech In Chile: Currently Latin America’s Easiest Market, But For How Long?” Med Device Online — https://www.meddeviceonline.com/doc/medtech-in-chile-currently-latin-america-s-easiest-market-but-for-how-long-0001
    3. Ministerio de Salud de Chile, Decreto Exento N° 25, Diario Oficial March 19, 2026, Núm. 44.404, CVE 2781436 — https://www.bcn.cl/leychile/navegar?idNorma=1222514
    4. Ministerio de Salud de Chile, Decreto Supremo N° 825 — https://www.bcn.cl/leychile/navegar?idNorma=141005
    5. Instituto de Salud Pública de Chile, announcement on the new norm regulating 39 medical devices including IVDs — ISP notice

    Disclaimer: This post is general information for educational and commercial-planning purposes. It is not legal advice and is not a substitute for advice from qualified Chilean counsel or confirmation with ISP on current filing instructions, product classification, or transition applicability to a specific portfolio.

    bioaccess® helps manufacturers sequence LATAM market access — registration ownership, IOR design, and distributor strategy — so Chile’s 2028/2029 waves do not become a last-minute scramble. Contact bioaccess® · Book a meeting

  • Corporativo Hospital Satélite Naucalpan: Named GT Metabolic MAGNET Feasibility Site, Not the COFEPRIS File

    Figures cited from the live ClinicalTrials.gov record NCT07085741 (study first posted 25 July 2025; last update posted 11 September 2026) and the published bioaccess® Mexico country page, verified 11 September 2026. General information, not legal or regulatory advice. Confirm current COFEPRIS, ethics-committee, and FDA rules with qualified advisers. We name only the facility and the trial those sources support. We do not publish site contact emails or phone numbers here. GT Metabolic Solutions is not claimed as a bioaccess® client. bioaccess® is not listed on this NCT.

    If you searched Corporativo Hospital Satélite clinical trial, Hospital Satelite Naucalpan MAGNET, GT Metabolic Mexico duodeno-ileostomy, MAGNET 2 Study Mexico, or “go direct to the Naucalpan site,” you followed a facility string ClinicalTrials.gov still publishes on NCT07085741. Corporativo Hospital Satelite in Naucalpan, Mexico is a real named facility on that record. It is not the operator of the COFEPRIS file.

    bioaccess®’s position is simple and it is not adversarial: Corporativo Hospital Satelite is the site. The First-in-Human CRO still owns COFEPRIS, institutional ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if Naucalpan is not the only fit. Sponsors who skip the CRO and email the hospital still have to rebuild that stack. A completed location row does not become a CRO.

    This page is the intercept for the Naucalpan / Hospital Satélite query. It does not clone clinical trials in Mexico. That page stays the country operating system. Sibling Mexican intercepts stay on their own buildings: Especialistas de la Piel y Cirugía Monterrey, New Hope Fertility Centre Mexico City, and Reina Madre Mexico City. Do not merge them into this slug.

    Why the hospital name wins the search — and why that is not a CRO

    NCT07085741 is an industry device listing. The registry’s own dates, retrieved 11 September 2026: study first submitted 8 April 2025; QC submitted 18 July 2025; first posted 25 July 2025; last update submitted 9 September 2026; last update posted 11 September 2026. Brief title: Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions DI Biofragmentable Magnetic Anastomosis System in Mexico. Official title ends with the sponsor acronym MAGNET 2 Study. Organization study ID: GTM-002. Lead sponsor: GT Metabolic Solutions, Inc., class INDUSTRY, responsible party the sponsor. No collaborator is listed. No CRO is listed.

    Design on the 11 September 2026 snapshot: interventional; intervention model description on the record says an open-label multicenter plan for up to 25 subjects at up to 3 study centers in Mexico; allocation N/A; no masking; primary purpose treatment; phase N/A; actual enrollment 10; status COMPLETED. Actual start 7 May 2025; actual primary completion 19 October 2025; actual completion 21 June 2026. Conditions: obesity; type 2 diabetes. The brief summary’s own words: evaluate the feasibility / performance, safety and initial efficacy of the MAGNET System, DI Biofragmentable for side-to-side duodeno-ileostomy diversion.

    Intervention, in the registry’s words: a device — MAGNET System, DI Biofragmentable; anastomoses achieved by magnetic compression. Primary outcomes listed: magnet placement (≥90% alignment during the index procedure); natural magnet passage without surgical re-intervention through 90 days; anastomosis patency confirmed radiologically through 90 days. The registry’s oversight module records no data monitoring committee, and marks the study as not FDA-regulated drug and not FDA-regulated device — a sponsor-entered flag about this listing, not a statement about what a later U.S. filing would require.

    Location rows currently published:

    • Corporativo Hospital Satelite — the only location on the record — Naucalpan, Mexico. No site contact or overall official is printed on the public row as of the 11 September 2026 snapshot. We will not invent a principal investigator name.

    Read the record as it is. A single Mexican facility string, an actual enrollment of 10, feasibility language in the brief summary, an industry sponsor, and no CRO in the public copy. That is the site-direct leak: a sponsor searching MAGNET System Mexico, GT Metabolic Naucalpan, or Hospital Satélite metabolic anastomosis now lands on a named hospital with no operator between them and the file. MAGNET 2 naming and earlier MagDI listings elsewhere on ClinicalTrials.gov mean we will not invent a “world’s first implant” claim for this page; the intercept is the Mexico facility string, not a global first-case press release.

    Naucalpan is a site. The CRO is the operator.

    A Naucalpan hospital campus can provide operating rooms, metabolic/bariatric procedural capacity, imaging for anastomosis patency, and local research staffing when contracted. That is necessary. It is not sufficient for an investigational-device study a U.S. board expects to survive later scrutiny.

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

    • Discuss investigator interest and procedural feasibility for a magnetic-anastomosis protocol — when that service is available and appropriate for your device, which is not automatic.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote procedure, visit, and local staffing costs for the cases they will physically run.

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

    • COFEPRIS. Clinical investigations sit under the Ley General de Salud and its implementing regulations. The submission is in Spanish: protocol, investigator brochure, informed consent, ethics approval, proof of insurance. A conversation with a Naucalpan hospital is not that dossier.
    • Institutional ethics. Ethics-committee review under NOM-012-SSA3-2012 sits in front of the COFEPRIS file, and the committee is tied to the host institution once the site is chosen.
    • Investigational import. Bringing an unapproved device into Mexico is a separate workstream from the trial authorization and from a later commercial registro sanitario. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a site-only premium here.
    • ISO 14155 monitoring, EDC, adverse-event reporting, and the TMF.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after the GCP and ethics documentation that rule defines. Eligibility is not clearance. See OUS FIH and FDA IDE.
    • Multi-country optionality. If one Mexican campus is not enough, a single-hospital MSA will not stretch to Colombia, Panama, Chile, or Brazil.

    Going direct to Corporativo Hospital Satelite is how you confirm a room. It is not how you open an investigational file.

    Site versus CRO

    Workstream What the Naucalpan hospital (site) typically owns What the CRO still owns
    Procedure OR, magnetic placement session, local imaging and staff Protocol fit, training, device accountability
    Ethics Institutional committee calendar and local rules Packet, ICF, IB alignment, deficiency cycle (NOM-012-SSA3-2012)
    National authority Not the permit holder by being listed on an NCT COFEPRIS clinical-investigation file, in Spanish
    Import Receiving and storage if contracted Importer of record for the investigational system
    Quality Hospital quality and the index procedure ISO 14155 monitoring, EDC, AE reporting, TMF
    FDA conversation Source documents from cases they run 21 CFR 812.28 narrative — eligibility, not clearance
    Country optionality One Naucalpan campus Colombia (INVIMA) and the rest of the bioaccess® platform

    How COFEPRIS and ethics sit next to the hospital

    Use clinical trials in Mexico for the full pathway. Facts a sponsor searching this facility needs on one screen, already published there and not re-averaged here:

    • Ethics at 4–6 weeks under NOM-012-SSA3-2012; COFEPRIS review at 4–8 weeks after ethics clearance; 2.8-month median start-up (attributed on that hub to NIH ClinRegs).
    • Published per-patient range $18,000–$30,000; 10+ pre-qualified sites across Mexico City, Guadalajara, and Monterrey.
    • The ~30-working-day COFEPRIS figure is registro sanitario / vía abreviada — a commercial market-access clock, not this trial clock.
    • All COFEPRIS submissions are in Spanish, including protocol, investigator brochure, and informed consent.
    • Under 21 CFR 812.28, foreign clinical data is eligible for FDA submission and review when the investigation meets that rule’s GCP conditions. Eligibility is not a guarantee of clearance or approval.
    • bioaccess®’s published cost comparison versus a typical U.S. or EU program is an experience-based estimate from work since 2010, not a formal study.

    We will not invent a facility-only day count. Ask for a protocol-specific calendar. A hospital email is not a COFEPRIS authorization.

    What the GT Metabolic public file actually supports — and what it does not

    • Device: MAGNET System, DI Biofragmentable (magnetic side-to-side duodeno-ileostomy anastomosis), as described on NCT07085741.
    • Sponsor: GT Metabolic Solutions, Inc. (industry). No collaborator. No CRO named.
    • Site: Corporativo Hospital Satelite, Naucalpan, Mexico — the only location row on the 11 September 2026 snapshot.
    • Design: interventional, phase N/A; actual n=10; COMPLETED; actual start 7 May 2025; actual completion 21 June 2026; brief summary uses feasibility / performance language; official title labels the file MAGNET 2 Study (org ID GTM-002).
    • Named investigator (as published): none on the public location or overall-official fields as of this snapshot. We do not invent one.
    • Not claimed here: that the NCT named bioaccess®; that GT Metabolic is a bioaccess® client; that we have MAGNET outcomes; that this listing is an FDA IDE; that the hospital holds a COFEPRIS authorization because it is printed on a registry row; that this Mexico row is the world’s first MagDI implant.

    What the CRO still does after you have a hospital name

    • Regulatory-fit, not tourism. Mexico is a sourced device geography. It is not automatically the right country for every indication. bioaccess® still runs clinical trials in Colombia and the rest of the platform.
    • Protocol, IB, ICF, insurance, and the COFEPRIS / ethics packet — in Spanish.
    • Importer of record and device accountability for the investigational system.
    • ISO 14155 monitoring and the 21 CFR 812.28 narrative for a later FDA conversation.
    • Optionality if one Estado de México campus is not enough.

    The founder podcast, when a conversation needs a voice, is Global Trial Accelerators™. Background on why registry rows keep outranking operators: ClinicalTrials.gov FIH sites vs the CRO.

    Frequently asked questions

    Can I contract Corporativo Hospital Satelite directly?

    You can try. The facility can discuss investigator interest, local procedure costs, and ethics-committee calendars. It cannot become your COFEPRIS applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because GT Metabolic listed Naucalpan. Contract the CRO; let the CRO activate the site.

    Did bioaccess® run the MAGNET 2 study?

    No public bioaccess® page says so. We will not invent that claim. This page intercepts the search; it does not claim the study.

    The registry says this is not an FDA-regulated device study. Does 21 CFR 812.28 still matter?

    It matters the moment you want the data to travel. That sponsor-entered flag describes this listing. If a U.S. submission is ever the goal, the GCP, ethics, and documentation conditions in 21 CFR 812.28 are what make foreign data eligible for FDA submission and review — and eligibility is still not clearance.

    Is this a first-in-human study?

    The brief summary uses feasibility / performance language and the official title calls the file MAGNET 2 Study. Earlier MagDI / MAGNET System listings for GT Metabolic exist on ClinicalTrials.gov outside Mexico. We intercept the Naucalpan facility string; we do not invent a global first-implant headline from this NCT alone.

    Is Colombia still an option?

    Yes. bioaccess® still runs trials in Colombia. A Naucalpan search is not an instruction to abandon INVIMA. See CRO in Colombia.

  • Compassionate use vs post-trial access in Latin America: do not file the wrong petition

    U.S. teams often arrive in Latin America with one phrase — “compassionate use” or “expanded access” — and expect a single regional petition that keeps patients on product after a trial. That phrase does not map cleanly onto the instruments that actually govern continued supply in the region. Post-trial access (PTA) after an authorized study is usually a different legal object from named-patient / exceptional-import routes. Filing the wrong one produces per-patient dossiers, wrong desks, and gaps at last-patient-last-visit.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page separates those routes using instruments already published on bioaccessla.com — starting with the LATAM post-trial access operator map and the country pillars for Argentina, Brazil, Panama, Chile and Costa Rica. It is not a quote and not legal advice. For operator diligence questions, use how to evaluate a LATAM PTA operator.

    Two problems that share vocabulary

    Write the board question before you ask regulatory for a “compassionate use letter”:

    • Post-trial access (cohort continuity). Identified participants who completed (or still sit in) an authorized clinical trial need continued investigational or successor product because benefit was shown or the statute / ethics framework requires free continuity. The filer is usually the sponsor. The cohort is defined by the trial.
    • Named-patient / exceptional / RAEM-style access. An individual patient outside a trial dossier — or treated as if outside it — needs a medicine or device that is not locally registered, often on a treating physician’s request, with quantity and validity windows that look nothing like a trial extension. The filer is often the patient, family, or a physician — not the sponsor cohort manager.

    U.S. FDA expanded access under 21 CFR 312 Subpart I is a permissive framework for use outside clinical trials. Puerto Rico sits in that U.S. customs picture on our operator map. Most LATAM countries either (a) impose a binding PTA duty after a trial, (b) offer a separate exceptional-import path, (c) soft-route continuation into “compassionate use” language, or (d) impose nothing. Mixing (a) with (b) is the filing error this page exists to prevent.

    Where binding PTA actually sits

    Across the twenty jurisdictions on the operator map:

    • Binding statutory mandate (10): Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua, Panama.
    • Binding instrument, weak or unassigned duty (3): Uruguay, Bolivia, Venezuela — including Venezuela’s BPC “procurar” language and Bolivia’s routing of continuation into per-patient DINAMED compassionate-use authorization.
    • No mandate (7): Mexico, Colombia, Paraguay, El Salvador, Dominican Republic, Cuba, Puerto Rico.

    Colombia’s Resoluciones 2378/2008 and 8430/1993 contain no post-trial supply obligation; Res. 8430 allocates only harm-related costs. Mexico’s NOM-012-SSA3-2012 §11.2.2 is an investigator duty about continued treatment and care, not a sponsor duty to keep shipping investigational product. Do not invent a Colombian PTA petition because a U.S. template says “expanded access.”

    Argentina: the cleanest PTA vs RAEM split

    Argentina is the teaching case because both instruments exist in public text and sponsors still swap them.

    Cohort PTA — Disposición ANMAT 12792/2016. This is the procedure for importing post-study medication, treatment and materials for participants in an ANMAT-authorized clinical pharmacology study. Article 3 requires the sponsor to file eight documents before the study ends. Article 4 gives DERM a twelve-month authorization per investigator and center. Article 3(g) requires a sworn declaration that supply is free to the participant, the treating institution, and the health coverage. Article 2 excludes authorized extension studies — those stay on the trial track. Detail: Argentina Disposición 12792 pillar.

    Named-patient exceptional import — Disposición 4616/2019 (RAEM). The Régimen de Accesibilidad de Excepción a Medicamentos makes no reference to clinical trials. Article 2(a) aims at medicines not registered with ANMAT but registered in an Anexo I country under Decreto 150/92, “destinados a tratar un paciente en particular.” Article 4(a) makes the patient (or family / legal representative) the responsible filer on a treating physician’s prescription and prohibits any gestor or intermediary. Article 12 limits Customs validity to 90 days; quantity caps sit at 90 or 180 days depending on course. Using RAEM for a trial cohort produces one expediente per patient, per renewal, on the wrong legal basis.

    If your Argentine continuation plan is “file RAEM for everyone who responded,” you do not have a PTA plan. You have a stack of individual exceptional imports that a sponsor is not even allowed to manage as gestor.

    Brazil: PTA is statute; compassionate / expanded / post-estudo share a service channel

    Brazil is the strongest PTA mandate in the region and still the easiest place to confuse vocabulary with ANVISA’s assistance-program menu.

    • PTA duty: Lei 14.874/2024 Chapter VI (Arts. 30–37) and Decreto 12.651/2025 Art. 31. The sponsor must file a post-study access plan with the CEP before the trial starts, guarantee free supply when the investigator judges the product the best therapeutic alternative, and may interrupt only on listed Article 33 grounds — including five years counted from commercial availability in Brazil. Ministry of Health / INAEP language: continued treatment “não é uma expectativa, mas um dever legal.” Devices and advanced therapies are in scope through Art. 37. Detail: Brazil Lei 14.874 pillar.
    • Import / assistance mechanics: For medicines, RDC 38/2013 still frames compassionate use, expanded access, and post-study supply as assistance programs. Post-study supply gets “um ofício autorizando o fornecimento,” not a comunicado especial (Art. 3 §2). ANVISA’s own public notice on Consulta Pública 1.210/2023 disclosed that between 2019 and 2023 it received 256 post-study supply requests alongside 558 compassionate use and 41 expanded access requests — three different request types on one service family, not one interchangeable petition.

    Operational takeaway: the CEP-approved PTA program and the ANVISA anuência are not optional synonyms for “compassionate use.” A device sponsor also has a statutory duty under Art. 37 while RDC 38/2013 still speaks in medicamento terms — resolve the post-close import path in the protocol, not at close-out.

    Panama, Chile, Costa Rica: PTA without a U.S.-style expanded-access label

    • Panama — Decreto Ejecutivo 21/2026 Art. 68 (Gaceta Oficial 30510-C, 23 April 2026): investigators and sponsors must ensure participant access when clinical or public-health benefit was shown, until commercialization in the country, via extension of the trial import permit for exclusive participant use. This is not Ley 419 de 2024 (the commercial medicines statute) and not the repealed Decreto Ejecutivo 1843/2014 path. Detail: Panama Decreto 21/2026 pillar.
    • Chile — Código Sanitario Art. 111 C (Ley 20.850): continuity “sin costo para el paciente… por todo el tiempo que persista su utilidad terapéutica,” with the duty following the sanitary-registration holder. That is an open-ended free-supply duty, not a 21 CFR Subpart I-style expanded-access grant. Detail: Chile Ley 20.850 pillar.
    • Costa Rica — Ley 9234 Arts. 28 and 53(k): the clearest express device PTA duty in the region — free post-study provision of “el medicamento, dispositivo o procedimiento,” “mientras lo requieran,” with exhaustive exit conditions. The statute mandates supply; it does not hand you a post-trial import route in Art. 55 (which addresses importation before an approved study begins). Detail: Costa Rica Ley 9234 device PTA pillar. Do not republish a second Costa Rica PTA page under a synonym slug.

    Where “compassionate use” language is doing different work

    • Bolivia: the clinical-studies norm routes continuation into the compassionate-use chapter with per-patient DINAMED authorization — a soft/weak PTA posture that is not Brazil’s pre-trial CEP plan.
    • Guatemala: AM 82-2019 Art. 64 is request-driven toward the sponsor; Art. 65 points at compassionate-use authorization by the DRCPFA. That is not automatic cohort PTA.
    • Honduras: Acuerdo 0256-ARSA-2025 Art. 63 creates a new free-supply mandate and names extension trial or compassionate use as routes — read Art. 63 next to Art. 18 numeral 5’s softer “cuando el patrocinador lo considere” language before you equate Honduras with Brazil.
    • United States / Puerto Rico: 21 CFR 312 Subpart I is permissive expanded access, not a LATAM-style sponsor PTA mandate. Do not paste Subpart I templates into an ANMAT 12792 or Panama Art. 68 file.

    Filing mistakes that look like vocabulary errors

    1. RAEM for an Argentine trial cohort. Wrong instrument, wrong filer, wrong quantity clock.
    2. Calling Brazil PTA “compassionate use” in the CEP cover letter. Brazil already distinguishes post-estudo from uso compassivo and acesso expandido in ANVISA request counts and RDC 38/2013 framing.
    3. Citing repealed PTA bases. Argentina Disp. 6677/2010 (repealed by Disp. 7516/2025), Ecuador AM 0075-2017, Honduras Acuerdo 041-2020, Panama Decretos 1843/2014 and 6/2015 — still appear in vendor decks.
    4. Assuming obligation implies pathway. Costa Rica and Ecuador show mandate without a clean post-trial import article. Mechanism has to be constructed; it is not “file compassionate use.”
    5. Inventing PTA where the map says none. Colombia and Mexico are the usual victims of template overreach.

    Operator checklist before you pick a petition name

    1. Classify the country: binding PTA / weak / none — using the current instrument on the operator map.
    2. Decide whether the patients are trial participants (cohort PTA) or named patients outside that dossier (exceptional / RAEM-style).
    3. Name the authorizing office and article you will put in the work order — not “the agency.”
    4. Confirm whether devices are textually in scope (Costa Rica Art. 53(k), Brazil Art. 37, Chile Art. 111 A, Peru Art. 2.1.36; Ecuador AM 00069-2024 is medicines-oriented).
    5. Appoint the importer of record for the period after the trial import permit lapses.
    6. Size cold chain and pharmacovigilance for the real duration — Brazil’s five-year clock starts at Brazilian commercial availability; Chile’s Art. 111 C has no commercialization endpoint.

    Working on a LATAM post-trial or exceptional-access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you need the instrument, desk, and petition type mapped for a live protocol country list, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    Is compassionate use the same as post-trial access in Latin America?

    Usually no. Post-trial access is continued supply to participants of an authorized trial under a country-specific duty or ethics framework. Compassionate use / exceptional / RAEM-style routes are typically individual-patient pathways that may have nothing to do with a closed or closing trial dossier. Argentina’s Disp. 12792/2016 versus Disp. 4616/2019 is the clearest split; Brazil’s ANVISA assistance channel literally counts compassionate use, expanded access, and post-study supply as separate request types.

    Can I use Argentina’s RAEM for my trial cohort?

    No. RAEM under Disposición 4616/2019 is an individual-patient exceptional import regime with no clinical-trial reference, patient-as-filer rules, and short quantity/validity windows. Cohort post-trial access runs on Disposición 12792/2016, filed by the sponsor before study end.

    Does Brazil treat post-study supply as compassionate use?

    No. Lei 14.874/2024 and Decreto 12.651/2025 create a sponsor PTA duty with a pre-trial CEP plan. RDC 38/2013 lists post-study supply alongside compassionate use and expanded access as assistance programs, but they are different request types. Ministry language calls post-study supply a legal duty, not an expectation.

    Which LATAM countries require post-trial access?

    Ten with binding statutory mandates: Argentina, Brazil, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras, Nicaragua and Panama. Three with weak or unassigned duties: Uruguay, Bolivia, Venezuela. Seven with none, including Colombia and Mexico. Read the current instrument — five countries changed frameworks between 2024 and 2026.

    Does Costa Rica’s Ley 9234 cover devices for PTA?

    Yes. Art. 53(k) expressly includes dispositivo alongside medicamento and procedimiento. Duration is “mientras lo requieran” under Art. 28. That is PTA, not a U.S. expanded-access petition — and the statute still does not hand you a dedicated post-trial import article.

    Does Colombia require compassionate use or PTA after a device trial?

    Colombia does not currently mandate post-trial access by statute. Voluntary continuity can still be arranged through the ethics committee, informed consent and general import rules. Do not file a U.S.-style expanded-access template as if INVIMA had a PTA desk for closed studies.

    How should a sponsor pick between PTA and named-patient filings?

    Start from patient status and country instrument. Trial participants in a mandate country → country PTA filing (Argentina 12792, Brazil CEP/ANVISA post-estudo, Panama Art. 68 extension, and so on). Individual patients outside that cohort → the country’s exceptional / compassionate / RAEM-style path, if one exists. Then confirm importer of record, cold chain and PV clocks. Use the ten diligence questions on the PTA operator evaluation page before you sign a work order.

  • INVIMA clinical-trial submission checklist for medical device studies in Colombia

    Sponsors keep asking “what are INVIMA requirements for clinical trial submission” as if Colombia had one petition that covers ethics, investigation authorization, import, and later Registro Sanitario. It does not. The device clinical-research file is a stack of instruments and published forms. Confusing any one of them with a sanitary-registration dossier is how first patient slips a cycle.

    I am Julio Martinez-Clark, CEO of bioaccess®. This checklist is for medical-device clinical research filings under INVIMA. It is grounded in the live Colombia clinical-trial execution pillar and is distinct from our INVIMA Registro for already FDA-cleared or CE-marked devices market-auth page and from the older FIH Colombia playbook. It is not a quote and not legal advice.

    Separate four desks before you open a folder

    Write four owners on one page before you assemble Spanish translations:

    1. Ethics (CEI). An INVIMA-approved research ethics committee at an IPS that holds a current BPC certificate.
    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 created under Resolución 2022035262.
    3. Import of the investigational article. Exceptional importation without sanitary registration where the device is the subject of clinical research authorized in Colombia — Decreto 4725 de 2005 Article 48(b), against a prior specialized-chamber opinion.
    4. Registro Sanitario (later, optional). Marketing authorization under the same decree’s Articles 18–19. Class IIb and III devices later need clinical evidence under Article 18(k). That is a commercial file, not the trial submission.

    If your Gantt has one bar labeled “INVIMA,” you do not have a submission plan. You have a hope.

    The governing instruments for device clinical research

    Colombia has no single device clinical-trial regulation. Three working instruments carry most of the obligation:

    • Decreto 4725 de 2005 — sanitary regime for human-use medical devices. Article 2 defines a device intended for clinical investigation. Article 36 authorizes a national or imported prototype (or controlled-technology biomedical equipment) for research and experimentation only, not for health care, against an INVIMA technical opinion. Article 48(b) is the import hook. Article 18(k) closes the commercial loop for class IIb and III Registro Sanitario.
    • Resolución 8430 de 1993 — scientific, technical and administrative rules for health research with human beings. INVIMA names it as the governing human-subjects instrument.
    • Resolución 2378 de 2008 — Good Clinical Practices with mandatory application for institutions researching medicines in humans, and the basis of the site BPC certificate that device trials also need in practice.

    INVIMA remains one of eight PAHO Level IV Regional Reference Regulatory Authorities. Since 2022 it has published device-study approval and non-approval registers and a public study search — facts already footed on the Colombia execution pillar.

    Published forms: what INVIMA actually asks you to file

    The operative paperwork is form-driven and published on INVIMA’s Investigación Clínica — Dispositivos page. Know which form belongs to which desk:

    • ASS-RSA-FM085 — checklist for the prototype-device technical-opinion request.
    • ASS-RSA-FM172 — SEDMRDIV technical-opinion request.
    • ASS-RSA-FM169 — initial study evaluation completed by the ethics committee.
    • ASS-RSA-FM170 — periodic reports.
    • ASS-RSA-FM171 — serious adverse event notification.

    There is no ambiguity about what to file. There is considerable skill in filing it in a form the SEDMRDIV will not bounce. Read INVIMA’s register of non-approved device studies before you assume a thin protocol will clear on first pass — that register exists specifically to show which defects cost applicants a cycle.

    Ethics and site prerequisites (do these first)

    A Colombian trial needs a CEI approved by INVIMA and a site holding a current BPC certificate. That certificate is issued to the IPS after INVIMA verifies compliance with Resolución 2378 de 2008 through inspection visits, runs for five years, and requires 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.

    INVIMA’s own 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 are the tier-1 clusters for most device programs. Replacing a site’s ethics committee is a formal BPC modification requiring a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO and both committees. Sponsors who treat CEI selection as an afterthought lose weeks here.

    Device dossier sections that stall first patient

    Build the Spanish + English pack so CEI and SEDMRDIV see the same investigation story:

    1. Protocol with stopping rules, endpoints, and a device description that matches the article you will import.
    2. Investigator’s Brochure / preclinical package — biocompatibility, sterilization, animal or bench data appropriate to risk class.
    3. Risk management file (ISO 14971) and technical documentation aligned to how you will later defend the product.
    4. IFU and investigator training plan for the investigational article.
    5. Clinical-trial insurance covering Colombian subjects.
    6. Investigator CVs, GCP certificates, financial disclosures.
    7. CEI-specific informed consent in Colombian regulatory language — not a U.S. IRB form with a Spanish machine translation stapled on.
    8. Site budgets and contracts executed in parallel with review so activation is not the bottleneck after the opinion lands.

    For prototype authorization under Article 36, the device may be used only for research and experimentation. Do not put a commercial Registro Sanitario number on the airway bill for investigational units. That pattern burns weeks at customs and contaminates both tracks.

    Import is a separate authorization

    Article 48(b) of Decreto 4725 de 2005 permits exceptional importation without sanitary registration or commercialization permit where the device is the subject of clinical research authorized in Colombia, subject to a prior opinion from the relevant specialized chamber. Plan CEI approval, the INVIMA concept, and the import authorization as sequential rather than fully parallel steps unless your operator has a documented reason to overlap them.

    Medicines sponsors use a different import hook — Article 96 of Decreto 677 de 1995 — and file initial protocol evaluation through Protocolos en Línea (exclusive since 2 January 2020) under tariffs 4070 / 4083. This checklist is the device path; do not paste drug-platform instructions into a device SEDMRDIV file.

    Timelines: what is published vs what is not

    There is no statutory day-count in force for protocol authorization. The measured figure footed on the Colombia execution pillar is an average of 5.1 months from filing to a definitive INVIMA concept, approving or rejecting, against a stable volume of roughly 90 protocol-evaluation requests a year (ConsultorSalud, June 2025). Five months to a decision is not fast. It is a measured average with a published rejection register behind it, which makes it forecastable.

    A clinical-research framework bill filed in the Cámara in August 2025 would introduce tacit approval — 7 calendar days for common-risk and 30 for high-risk research — and would classify first-in-human studies and novel implantable devices as high-risk. It is not law. Do not put that clock in a board slide as if it were already INVIMA practice.

    Common mistakes that stall first patient

    • Filing Registro Sanitario paperwork as if it were the trial file. Articles 18–19 evaluate marketing authorization. Article 36 / 48(b) evaluate investigation and exceptional import. Wrong petition, wrong desk.
    • Skipping CEI / BPC prerequisites. An INVIMA opinion does not cure a site without a current BPC certificate or an unapproved committee.
    • Ignoring the non-approval register. INVIMA publishes why device studies were refused, withdrawn, or left pending response. Read it before you invent a “Colombia is unpredictable” narrative.
    • Treating import as automatic once the opinion issues. Article 48(b) still needs the specialized-chamber prior opinion and a clean investigational shipping story.
    • 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; Res. 8430 allocates only harm-related costs. See the LATAM PTA operator map and our companion post on compassionate use vs post-trial access.
    • One workstream for FIH evidence and later commercial registro. Article 18(k) is why the evidence and the registration strategy belong in the same plan — not why they share one submission form.

    Drug path in one paragraph (so you do not mix them)

    For medicines, Resolución 2378 de 2008 and Protocolos en Línea govern protocol evaluation; adverse-event content and periodicity follow Resolución 2011020764 de 2011 under Article 146 of Decreto 677 de 1995; controlled substances involve the Fondo Nacional de Estupefacientes. Device sponsors should not use drug tariffs or the medicines Protocolos en Línea path as a substitute for SEDMRDIV forms ASS-RSA-FM085 / FM172 and the CEI form ASS-RSA-FM169.

    Related reading on bioaccessla.com

    Planning an INVIMA device clinical-research file? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions and 2–8 °C GDP cold chain across the region. To discuss dossier sequencing for Bogotá, Medellín or Cali — CEI, SEDMRDIV opinion, Article 48(b) import, and optional later Registro Sanitario — contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

    Frequently asked questions

    What are INVIMA requirements for clinical trial submission for medical devices?

    There is no single “INVIMA clinical trial form.” Device programs combine Decreto 4725 de 2005 (Arts. 36 and 48(b) for prototype authorization and exceptional import), Resolución 8430 de 1993 for human-subjects rules, an INVIMA-approved CEI evaluation (form ASS-RSA-FM169), and SEDMRDIV technical-opinion paperwork (ASS-RSA-FM085 / ASS-RSA-FM172), with the site holding a current BPC certificate under the Resolución 2378 de 2008 inspection regime. Registro Sanitario under Articles 18–19 is a later marketing petition.

    Is the INVIMA trial file the same as Registro Sanitario?

    No. Registro Sanitario is the marketing authorization that lets a device be sold in Colombia. The investigation path authorizes research use and, separately, exceptional import of the investigational article. Class IIb and III sponsors should plan clinical evidence with Article 18(k) in mind, but they should not file the commercial dossier as if it were the trial submission.

    Which INVIMA body reviews device research protocols?

    The Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV) issues technical and methodological opinions on device and IVD research protocols. Since Resolución 2022035262 of 20 September 2022, the GICASE group supports that chamber for clinical research.

    How long does INVIMA take to authorize a clinical study?

    There is no statutory day-count. The measured average footed on our Colombia execution pillar is 5.1 months to a definitive concept (approve or reject). Plan CEI, INVIMA concept and import as sequential critical-path items unless you have a documented overlap plan.

    Does every Colombian site need a BPC certificate?

    Yes in practice for the institutions that run interventional research under INVIMA oversight. The BPC certificate runs five years and depends on Sistema Único de Habilitación services (pharmaceutical, clinical laboratory, sample collection) inside the same institution. Contracting those services outside the habilitación adds documentation to every BPC modification.

    Does Colombia require post-trial access after the study closes?

    No statutory PTA mandate. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no post-trial supply obligation. Voluntary continuity programs can still be run through ethics-committee and informed-consent expectations. Compare that to the ten LATAM countries with binding PTA duties on the operator map.

  • Panama CNBI procedure checklist: Type II ethics, MINSA parallel track, RESEGIS, and import

    Panama FIH calendars die on procedure, not on a missing brochure. Sponsors ask how to obtain MINSA approval for a medical device clinical trial and then treat ethics, CNBI registration, RESEGIS, and investigational import as a single checkbox. They are not.

    I am Julio Martinez-Clark, CEO of bioaccess®. This is the Panama CNBI / Type II ethics + import logistics checklist drawn from clocks and instruments already published on our Panama hubs and ethics architecture page. It is not a quote and not a new statutory clock.

    What “CNBI procedure” actually means

    Ordinary ethics review in Panama runs through a Type II-accredited committee registered with the Comité Nacional de Bioética de la Investigación (CNBI). On our published ethics architecture page, ordinary ethics review is capped at 20 business days. High-risk protocols — Class III implants and novel biomaterials — open MINSA and Type II ethics in parallel, not as a forced serial queue under Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C).

    CNBI registration of the committee is not the same file as MINSA authorization, and neither is RESEGIS study registration. Budget them as three lines.

    Panama procedural checklist (sponsor-ready)

    1. Confirm risk track. High-risk / Class III and novel biomaterial work belongs on the parallel MINSA + Type II ethics track. Do not price a serial ethics-then-authority plan if your device is on the high-risk path already described on our Panama Class III FIH materials.
    2. Pick a CNBI-registered Type II committee that already reviews device protocols at the implanting hospital or network. Institutional committee first; national desk in parallel or after depending on track — see centralized vs decentralized ethics review.
    3. Assemble the ethics packet in Spanish where the committee requires it: protocol, IB, IFU/training plan, consent, investigator docs, insurance certificate language the EC will accept. Insurance certificate timing is its own LATAM FIH bottleneck; do not assume the US binder travels unchanged.
    4. File MINSA on the high-risk track in parallel with ethics when that is the published path — not “after CEI approval” by US habit.
    5. Register in RESEGIS before start. Our ethics architecture page is explicit: register in RESEGIS before start on the Panama high-risk track. Public RESEGIS reporting is not a substitute for the authorization file.
    6. Separate investigational import from ethics. Import logistics (permits, temperature, customs release, site receipt) sit on the Gantt next to ethics — see investigational device import as the LATAM FIH bottleneck. A 20-business-day ethics band does not move a device that is still on a dock.
    7. Design for 21 CFR 812.28 inspectability from day one (English-reconstructable source, consent, monitoring). Panama speed is useless if FDA cannot reconstruct the file — see 812.28 inspectability.
    8. If patients may continue after LPLV, open the PTA file early. Since 23 April 2026, Panama requires post-trial access under Decreto Ejecutivo 21/2026 Art. 68. Mechanism is import-permit extension framing, not a US “compassionate use” label — see Does Panama require post-trial access? and the Art. 68 pillar.

    Import / logistics steps that belong on the same week plan

    • Named importer of record for investigational units (trial import is not commercial registro).
    • Lead times for apostille/legalization, Spanish labeling, and temperature-controlled lanes — use study-specific numbers; do not invent a Panama median here.
    • Site receipt SOP and quarantine release before SIV.
    • Endorsement path if a second country is added later (insurance and import), instead of pretending the Panama file automatically covers Country 2.

    Common friction points

    • Treating CNBI, MINSA, RESEGIS, and import as one “approval.”
    • Serializing high-risk work that the published track opens in parallel.
    • Pasting a Panama 3–5 week ethics band onto Brazil, Argentina, or Colombia calendars (our ethics page warns against that explicitly).
    • Ignoring Art. 68 until a site asks who pays for continued supply.

    Who does what (sponsor vs local stack)

    • Sponsor: locks protocol/IB risk class, FDA strategy (including 812.28 inspectability), insurance limits, and whether Art. 68 continuation is in scope before first patient.
    • Type II / CNBI-registered committee: ethics review of protocol, consent, and investigator packet on the ordinary or high-risk track.
    • MINSA: national authorization path for the clinical investigation — parallel on high-risk, not a US-style afterthought.
    • RESEGIS: study registration before start on the published high-risk track.
    • Importer / logistics: investigational release into Panama and site receipt; later, if Art. 68 applies, the import-permit extension story for continued supply.

    If one vendor claims to “own Panama approval” without naming those five lines, you do not yet have a procedure checklist — you have a slogan.

    Clocks you may reuse — and clocks you may not invent

    Reuse: CNBI/Type II ordinary ethics cap of 20 business days; high-risk parallel MINSA + ethics; Panama ethics bands already on the country hub and the Panama / El Salvador FIH cost vs US page. Do not invent a new MINSA day-count, a new per-patient average, or a new RESEGIS SLA on this page.

    If you are choosing Panama for a Class III or biomaterial FIH, send bioaccess® the protocol stage, risk class, intended US filing, and target first-patient month. We will map CNBI committee, MINSA track, RESEGIS, import, and Art. 68 on one calendar — Global Trial Accelerators™ style, one accountable timeline.

  • How to evaluate a LATAM post-trial access operator: 10 questions to ask

    Most “who does post-trial access in Latin America” shortlists are vendor decks. The diligence question is whether the operator can still import, cold-chain, report safety, and keep patients on product years after database lock — under the instrument that is actually in force in that country.

    I am Julio Martinez-Clark, CEO of bioaccess®. Use these ten questions before you sign a PTA work order. They map to our published LATAM post-trial access operator map and legal architecture pillars. This is not a quote and not legal advice.

    Regulatory questions

    1. Which current instrument and article create the duty? Ask for the citation they will put in the work order: Panama Decreto Ejecutivo 21/2026 Art. 68, Brazil Lei 14.874/2024 Arts. 30–37 and Decreto 12.651/2025, Chile Código Sanitario Art. 111 C (Ley 20.850), Argentina ANMAT Disposición 12792/2016, Peru DS 021-2017-SA Arts. 115–118, Costa Rica Ley 9234 Art. 53(k). If the proposal still cites a repealed Panama Decreto 27/2024 path or treats Argentina Disposición 6677/2010 as if Disp. 7516/2025 erased 12792, stop.
    2. Which office authorizes the continued-supply file? Name the authorizing desk — not “the agency.” Argentina’s post-study import is a Disposición 12792 filing before study end; Brazil’s CEP/ANVISA stack and RDC 38/2013 framing are not interchangeable with Argentina’s cohort route. Wrong office is a multi-month miss.
    3. Does the country mandate PTA for devices at all? Our operator map is explicit: Colombia does not currently mandate post-trial access by statute. Ecuador stays off the “express device mandate” column unless a primary instrument says otherwise. Do not buy a Colombia PTA program that invents a duty the map does not list.

    Import and supply questions

    1. Who is importer of record after the trial import permit lapses? PTA fails when the trial-only import story dies at LPLV. Ask who holds the extension, special-import, or successor authorization, and whether that role is the same entity named as registration holder later.
    2. Can they keep 2–8 °C (or the protocol’s real band) for years past database lock? Multi-year cohort supply is a GDP problem, not a courier problem. Ask for the named depot, excursion SOP, and who owns product that is still on patients after the CRO’s “study close” invoice.
    3. What are the pharmacovigilance onward-transmission clocks? PTA is still a safety file. Ask who receives SAEs from sites, who files to the national authority, and who keeps the SDEA alive when the original CRO work order ends.

    Contract and liability questions

    1. Is there a signed SDEA within a defined window? Our legal-architecture pillar treats ICH E2A/E2F-style safety exchange as part of the PTA stack, not an afterthought. “We will paper PV later” is a red flag.
    2. Which country DPA model is on the table? Argentina Ley 25.326 / AAIP tooling, Brazil LGPD, Chile Ley 21.719 (in force 1 December 2026), Peru DS 016-2024-JUS, and Mexico’s LFPDPPP stack are not one regional template. Ask for the controller/processor labels in local terms.
    3. Is sponsor accession a condition of signature? Product-liability and patient-continuity risk should not sit only on a local operator while the US sponsor stays off the accession page. If the work order is silent, assume the gap is intentional.
    4. What is the patient-continuity run-off if the operator exits? Ask for the written handoff: who imports next, who holds temperature-controlled stock, who tells the investigator and the patient, and which instrument keeps the file open. A PTA proposal without a run-off clause is a brochure.

    Red flags in proposals

    • Reliance on repealed or misnamed instruments (wrong Panama decreto; “Ley 419/2023” folklore; Argentina RAEM sold as the trial-cohort PTA route).
    • Mixing commercial registro / IOR sales with PTA duty as if they were the same file.
    • No named authorizing office, no cold-chain owner, no PV clock, no DPA country, no accession language.
    • A single “LATAM PTA” price that pretends Brazil Art. 37, Chile Art. 111 C, and Panama Art. 68 are one operating system.

    What “operator” has to mean for multi-year PTA

    A LATAM PTA operator is not a one-time importer who can forward a carton. The map pillar’s job is country×instrument clarity; the operator’s job is to keep that instrument executable after the CRO’s study budget ends. That usually means one accountable party for continued import authorization, GDP storage, PV exchange, and patient-facing continuity — not a chain of layered subcontracts that each expire at database lock.

    Compare that to commercial market access. The LATAM registration holder / IOR line and the public LATAM Launch Subscription card answer who holds registro for already FDA-cleared or CE-marked devices. PTA answers who keeps beneficial investigational (or successor) supply moving under a trial-era duty. Mixing the two in one proposal is how diligence fails.

    How to use the answers

    Score each question pass/fail against the country you actually need. Then open the country pillar: Panama Decreto 21/2026 Art. 68, Brazil Lei 14.874, Argentina Disp. 12792/2016, Chile Ley 20.850 / Art. 111 C, Peru DS 021-2017-SA. Market-access registro questions stay on LATAM market access — they do not replace the PTA diligence file.

    If you want bioaccess® to run the diligence against a live protocol country list, send the protocol stage, device risk class, and which countries already have patients on treatment. We will map the instrument, authorizing office, and contract gaps — without inventing a duty the statute does not create.

  • Clinica INO Bogotá: The NCT Campus String Is Not the INVIMA File

    Figures cited from a ClinicalTrials.gov LATAM facility sweep (API pull 1 September 2026, 6:32 PM ET) and published bioaccess® country pages. Registry ranking is not a bioaccess® claim that we ran any of these studies. General information, not legal or regulatory advice. Confirm current INVIMA, ethics, and FDA rules with qualified advisers. We name only the facility strings and example NCT IDs those sources support. We do not invent a principal investigator. We do not claim Clinica INO Bogotá as a bioaccess® client.

    If you searched Clinica INO Bogota first-in-human, Clinica INO Bogotá clinical trial, Clinica INO CRO, Clinica INO compression stockings, or “go direct Clinica INO Bogotá,” you followed a campus string ClinicalTrials.gov still publishes. Clinica INO in Bogotá, Colombia, is a real named clinic-campus string on ClinicalTrials.gov. The two public DEVICE rows on this string are borderline aesthetic/device work (graduated compression stockings / air-travel after aesthetic surgery) — still a site-direct search leak, not a CRO. It is not a first-in-human medical-device CRO, and it is not the operator of the INVIMA file.

    bioaccess®’s position is simple and it is not adversarial: the clinic is the site. The First-in-Human CRO still owns INVIMA, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package — plus the option to add Colombia or another Latin American country if this campus is not the only fit. Sponsors who skip the CRO and email the clinic still have to rebuild that stack. An NCT location row is not a CRO.

    This page is the named Bogotá Clinica INO campus. It is DISTINCT from Fundación Reumatología Fernando Chalem Bogotá (CMS 96132), Clínica del Country Bogotá (CMS 96051), Fundación CTIC Bogotá (CMS 96096), Fundación Neumológica Colombiana Bogotá (CMS 95952), Fundación Cardioinfantil Bogotá (CMS 95797), and Fundación Santa Fe de Bogotá (CMS 95516). Sharing Bogotá is not a license to collapse them. Clinica INO is not Chalem. Clinica INO is not Country. Clinica INO is not CTIC. This intercept does not recommend Colombia for new FIH execution.

    Why the campus name wins the search — and why that is not a CRO

    Device registries write the city, the hospital, and a list of NCT IDs. They rarely write the CRO. On the 1 September 2026 ClinicalTrials.gov LATAM sweep (interventional studies; all years; complete dump), this campus sits here after filters:

    Counts come from leftover unique strings after the last live leftover-site batch plus unique NCT IDs in /workspace/five-trials/ctgov-raw/all_interventional.jsonl (17497 studies; ClinicalTrials.gov LATAM facility sweep, API pull 1 September 2026, 6:32 PM ET; dump confirmed 1 September 2026). Alias strings are listed separately. We do not publish a unique-study union across alias strings. We do not invent a global CSV rank. We do not invent unpublished CMS IDs. Registry ranking is not a bioaccess® claim that we ran any of these studies.

    • Clinica INO (Bogotá, Colombia) — canonical NCT string: ALL interventional n=2; DEVICE n=2. Example NCT IDs: NCT07808931, NCT07810192.

    Cite canonical ALL n=2 and DEVICE n=2. Do not clone Chalem, Country, CTIC, Neumológica, Cardioinfantil, or Santa Fe onto this slug. Colombia NEW-FIH line unchanged: bioaccess® does not currently recommend Colombia for new FIH trial execution. The DEVICE n=2 rows are borderline aesthetic/device (graduated compression stockings / air-travel after aesthetic surgery) — still publish as a site-direct intercept so sponsors do not go facility-direct.

    Those are unique NCT IDs per facility string + city + country. They are not a count of first-in-human device programs bioaccess® ran. They are how a sponsor searching the hospital name lands on a campus without landing on an operator.

    We cite the IDs as facility evidence. We will not invent a PI. We will not claim bioaccess® ran any of them. No live bioaccess® case-study page names this clinic as a client site.

    That is the leak: a founder searching Clinica INO Bogotá first-in-human finds ALL n=2 (DEVICE n=2) without finding INVIMA. Borderline aesthetic/device rows (graduated compression stockings / air-travel after aesthetic surgery) still put a campus string in front of a CRO. A named clinic is still a site. An NCT location row is not a CRO.

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

    A named clinic can provide rooms, coordinators, institutional ethics calendars, and investigators who already appear on NCT rows. That is necessary. It is not sufficient for a first-in-human medical device study a U.S. board expects to survive FDA review.

    What the clinic can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether a protocol can sit in an existing service line.
    • Share institutional ethics-committee calendars and hospital research rules.
    • Quote visit, staffing, and local procedure costs for the cases they will physically run.

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

    • INVIMA. INVIMA is the national file for an investigational device in Colombia. Resolución 8430/1993 still sits on the ethics and research side of that stack. A hallway conversation on this campus is not the INVIMA dossier. Resolución 2378 does not govern device clinical trials — see the live country pages rather than importing a drug-GCP resolution onto a device file. A hallway conversation at Clinica INO is not a Chalem file, not a Country file, and not a CTIC file.
    • Investigational import. Ethics letter, investigator’s brochure, and an importation permit — end-to-end work, not a PI email. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a campus-only premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF. The site may run visits. The CRO runs the quality system the FDA will later ask about.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review after GCP / ethics documentation. Eligibility is not clearance, and a site MSA does not produce it.
    • Multi-country optionality. If enrollment or the indication later needs another Latin American country, a single-hospital MSA will not stretch.

    Going direct to this campus is how you confirm a room. It is not how you open an investigational file.

    How INVIMA actually works (the short version)

    Use CRO in Colombia. Published comparison already on the Panama country page: Colombia ethics typically 4–6 weeks; per-patient $15,000–$25,000. bioaccess® still runs clinical trials in Colombia — local entity, INVIMA clocks in-country. We pick the country the device needs. A hospital email in Montería is not INVIMA clearance.

    Ask for a protocol-specific calendar. A hospital email is not INVIMA clearance. bioaccess® manages the file. That is CRO work, not site work.

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

    Do not smear the hospital

    Clinica INO is a serious named Bogotá campus on the public registry. ALL n=2 and DEVICE n=2 are registry volume, not a punchline — including the borderline aesthetic/device compression-stocking rows. Do not invent a PI. Do not smear the clinic. Do not claim bioaccess® ran these studies. Use the site when the protocol fits. Hire the operator. Colombia NEW-FIH guidance stays unchanged on this page.

    What the CRO still does after you have the campus on a slide

    1. Regulatory-fit, not tourism. This geography is sourced. One campus is not automatically the right room for every indication. bioaccess® still runs trials in Colombia and the rest of the platform.
    2. Protocol, IB, ICF, insurance, and the INVIMA / ethics packet.
    3. Importer of record and device accountability.
    4. Site activation that is more than a tour: contracts, training, investigational product, EDC, monitoring plan. Activate this campus only if it fits the protocol.
    5. ISO 14155 monitoring and the 21 CFR 812.28 narrative so the dataset is built for a later Pre-Sub, IDE, 510(k), De Novo, PMA, or HDE — eligibility, not a promise of FDA action.

    The firm was founded in 2010. That is the operator layer around a campus string.

    Colombia is still on the map

    Public line, unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial registration remains. The country page’s published comparison: Panama ethics 3–5 weeks vs. Colombia 4–6 weeks; per-patient $12K–$22K vs. $15K–$25K as published on clinical-trials-panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.

    Frequently asked questions

    Can I contract Clinica INO Bogotá directly for a device FIH?

    You can try. The clinic can discuss investigator interest, local visit costs, and ethics calendars. It cannot, by ranking on ClinicalTrials.gov, become your INVIMA applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® run the NCT IDs listed here?

    No public bioaccess® case-study page names this clinic. We will not invent that claim. This page intercepts the search; it does not claim the studies.

    Is this the same page as Fundación Reumatología Fernando Chalem or Clínica del Country Bogotá?

    No. Fundación Reumatología Fernando Chalem Bogotá is CMS 96132. Clínica del Country Bogotá is CMS 96051. Fundación CTIC Bogotá is CMS 96096. This page is Clinica INO only.

    Does this page recommend Colombia for a new FIH?

    No. The public line is unchanged: bioaccess® still runs clinical trials in Colombia — local entity, Miami headquarters, own CRO in Colombia — and bioaccess® does not currently recommend Colombia for new FIH trial execution because INVIMA clinical-trial approval timelines have become unpredictable. INVIMA commercial registration remains. We pick the country the device needs.

    Are NCT07808931 and NCT07810192 classic implant FIH programs?

    No claim of that. Public rows on this campus string are borderline aesthetic/device (graduated compression stockings / air-travel after aesthetic surgery). They still create a site-direct search path. We cite them as facility evidence only.

    Did bioaccess® run NCT07808931 or NCT07810192?

    No. We cite them as facility evidence. We will not invent a sponsor or a PI. We will not claim bioaccess® ran these studies.

    Next step

    If the search that brought you here was this campus, start as the operator: contact bioaccess® or book from First-in-Human CRO. Bogotá sibling (do not merge): Fundación Reumatología Fernando Chalem Bogotá (CMS 96132).

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Brazil RA Consultant / ANVISA Regulatory Consultant: BRH Stack vs Freelance Advice

    General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. Where a card is mentioned, only the locked public LATAM Launch Subscription (USD 7,500/year all-in for the first device family) already published on market-access and the holder hub applies. No unpublished client. No PHI. Always bioaccess®.

    If you searched Brazil RA consultant medical device, ANVISA regulatory consultant, or Brazil regulatory affairs consultant medical device, you were looking for advice that is often mistaken for the BRH / detentor / ANVISA operator stack. This page owns that search intent: BRH stack vs freelance advice. It does not name freelancers. No PHI. Always bioaccess®.

    The leak: a consultant who drafts ANVISA dossiers, advises on classification, or coaches RDC language is still not the ethics calendar + IOR + site network + inspection-ready ops stack — and for commercial devices is still not the Brazilian Registration Holder (BRH / detentor) named on the certificate. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns that stack.

    What the search usually means vs what execution requires

    • Search intent often means: someone who “knows ANVISA” for cadastro/registro, BGMP awareness, or clinical submission coaching under RDC 837/2023.
    • Execution requires: Portuguese dossier discipline; CEP ethics capped on live Brazil hubs; ANVISA trial authorization where applicable; investigational or commercial import entity; sites that enroll; or, for commercial SKUs, BRH / detentor on the certificate plus IOR on the entry.
    • A freelance ANVISA RA retainer usually covers: gap assessment, dossier outline, and meeting prep — not BRH ownership and not ISO 14155 monitoring.
    • Do not collapse: INMETRO / ANATEL homologation, BGMP audit pass-through, and BRH into one “Brazil RA” invoice line without reading the holder hub.

    ANVISA / BRH stack: trial vs commercial

    Use clinical-trials-brazil: combined ethics + ANVISA typically 6–10 weeks under Law 14874 and RDC 837/2023; CEPs capped at 30 business days; published per-patient range $20,000–$35,000 on that hub. Trial authorization and later market registration are separate workstreams. We will not invent a new ANVISA clock on this page.

    Commercial BRH / IOR: Brazil ANVISA Registration Holder / IOR (BRH / Detentor). Locked public card: LATAM Launch Subscription USD 7,500/year all-in for the first device family on market-access and LATAM Registration Holder and IOR. Brazil Class III/IV + INMETRO pass-through and BGMP manufacturing-site audit as pass-through lines stay on that hub — this intercept is not a second price list. Trial IOR: importer of record for clinical trial devices.

    BRH stack vs freelance advice

    1. Who is the detentor / BRH? ANVISA names a Brazilian legal entity on the registration. A consultant who helps you appoint is not the detentor.
    2. Who owns Portuguese sworn pages where required? Inside the published all-in card on the hub — do not compare a dossier-only sticker to USD 7,500 all-in.
    3. Who owns BGMP / INMETRO pass-through? Published outside the flat fee on the holder hub — not a freelancer rate we invent here.
    4. Who owns CEP + ANVISA when the SKU is FIH? CRO execution on clinical-trials-brazil — not a classification PDF.
    5. Who owns inspection-ready ops? ISO 14155 monitoring and TMF/ISF — bioaccess® when you hire the CRO stack.

    Colombia line (cluster hygiene)

    Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®. Brazil ANVISA success does not reopen Colombia FIH from this page.

    How sponsors mis-buy “ANVISA RA”

    Brazil searches collapse BRH support, clinical RDC 837/2023 coaching, and INMETRO pass-through into one “RA consultant” phrase. Separate them. FIH / early feasibility lives on clinical-trials-brazil. Commercial detentor lives on ANVISA holder / IOR. Homologation and BGMP pass-through stay on the holder hub terms — not invented here. bioaccess® owns the operator conversation end-to-end when you hire the stack. Always bioaccess®.

    Frequently asked questions

    Is an ANVISA regulatory consultant a CRO?

    No. Advice is not CEP + ANVISA start-up, and it is not BRH. bioaccess® sells the operator stack for both trial and commercial SKUs when that is the real job.

    Does bioaccess® replace freelancers?

    We do not name freelancers. We intercept Brazil RA consultant / ANVISA regulatory consultant intent and convert to contact, market-access, clinical-trials-brazil, or the BRH holder page.

    Is BRH support the same as the all-in holder card?

    No. “Help with BRH” is not own-entity detentor. See the Brazil holder sibling and the LATAM hub for the locked USD 7,500/year all-in card.

    Rates?

    No invented Pure Global or freelancer rates. Locked public card only when a card is mentioned.

    Siblings?

    Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA

    Next step

    Brazil RA / ANVISA search → operator path: contact bioaccess® · market-access · clinical-trials-brazil · ANVISA holder / IOR · siblings Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Colombia RA Consultant / INVIMA.

    Julio G. Martinez-Clark, CEO · bioaccess®

    Operator checklist sponsors still skip after hiring “RA”

    When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

    • Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
    • Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
    • Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
    • Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
    • Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
    • Country-select owner: apply the Colombia public line before anyone sells you a new INVIMA FIH from an RA search; keep Mexico, Brazil, Panama, Chile, and El Salvador on the recommended FIH conversation where the live hubs support it.
    • Commercial card owner: if the SKU is already-cleared devices, use the locked public LATAM Launch Subscription on market-access — USD 7,500/year all-in for the first device family — and do not invent freelancer comparables on this page.
    • Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

    bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This intercept is public content only. It is not leftover-site hospital FIH copy, not insurance underwriting, and not a Magical BTK page. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

    Repeat the thesis in plain language for searchers who skim: hiring a freelance RA consultant is not the same as running FIH, early feasibility, or registration execution. You still need the ethics calendar, IOR/import, site network, and inspection-ready operations. bioaccess® owns that LATAM stack as FIH CRO plus local RA/IOR operator. Convert via contact and market-access. No invented rates. No named freelancers. No PHI. Always write bioaccess® with the registered mark.

  • Colombia RA Consultant / INVIMA Regulatory Consultant: Registration Operator vs Freelance Advice

    General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. Where a card is mentioned, only the locked public LATAM Launch Subscription (USD 7,500/year all-in for the first device family) already published on market-access and the holder hub applies. No unpublished client. No PHI. Always bioaccess®.

    If you searched Colombia RA consultant medical device, INVIMA regulatory consultant, or Colombia regulatory affairs consultant medical device, you were looking for registration / operator clarity often mislabeled as freelance advice. This page owns that search intent: registration operator vs freelance advice. It does not flip into “do FIH in Colombia.” No named freelancers. No PHI. Always bioaccess®.

    The leak: a consultant who drafts INVIMA dossiers or advises on classification is still not the ethics calendar + IOR + site network + inspection-ready ops stack — and on Colombia, the public FIH line is closed for new trial execution anyway. What remains core is INVIMA commercial medical-device registration and holder / IOR operations. bioaccess® is the LATAM FIH CRO (in countries the public line recommends) and the local RA / IOR operator for Colombia registration.

    Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

    What the search usually means vs what execution requires

    • Search intent often means: someone who “knows INVIMA” for registro sanitario, CCAA importer rules, or historical trial coaching.
    • Registration execution requires: Colombian legal entity as titular on the sanitary registration; CCAA importer rules beside the holder; certified translations where required; tecnovigilancia as holder; government fees and RFI ownership — see INVIMA medical device registration checklist.
    • A freelance INVIMA RA retainer usually covers: dossier outline and agency etiquette — not own-entity titular and not post-market as holder.
    • FIH execution is not the offer on this page. Historic Colombia FIH copy elsewhere is not a reason to book a new INVIMA clinical CTA from this intercept.

    INVIMA registration operator stack (not new FIH)

    Use Colombia INVIMA Registration Holder / IOR and the checklist above. Locked public card: LATAM Launch Subscription USD 7,500/year all-in for the first device family on market-access and LATAM Registration Holder and IOR. We will not invent INVIMA freelancer rates. Submission Guarantee language on the hub is workmanship (complete dossier, certified language, fees paid on schedule) — not a regulator-clock guarantee.

    For context on why sponsors still find “CRO in Colombia” in search, see CRO in Colombia — read that page together with the public line above. Country 2 for new FIH remains Panama, Chile, Brazil, Mexico, or El Salvador — not a new Colombian FIH CTA from an RA-consultant intercept.

    Investigational import (when a protocol runs in a recommended country) is importer of record for clinical trial devices — a trial object, not this Colombia registration SKU.

    Registration operator vs freelance advice

    1. Who is the titular? INVIMA names a Colombian legal entity. A consultant who helps you appoint is not the titular.
    2. Who owns CCAA importer rules? Importer rules sit next to the holder — see the live checklist — not instead of it.
    3. Who runs tecnovigilancia after the certificate is live? Holder duty. A one-time filing shop is not that.
    4. Who owns RFIs and government fees? Operator clarity beats a vague “we’ll help with INVIMA” email.
    5. Who refuses to sell you new FIH in Colombia? bioaccess® — on the public line — while still owning commercial registration.

    How sponsors mis-buy “INVIMA RA”

    The mis-buy on Colombia is specific: sponsors search INVIMA regulatory consultant when they need either (a) commercial titular / CCAA / tecnovigilancia operations, or (b) historic FIH language that the public line no longer recommends for new trial execution. This page answers (a) and refuses to reopen (b). Use INVIMA medical device registration checklist and INVIMA holder / IOR. For FIH country selection, stay on Panama, Chile, Brazil, Mexico, or El Salvador per the public line. Always bioaccess®.

    Frequently asked questions

    Is an INVIMA regulatory consultant a CRO?

    No. And this page is not selling Colombia FIH CRO execution. It sells clarity on registration operator vs freelance advice, with bioaccess® as the holder / IOR operator for commercial INVIMA work.

    Does bioaccess® recommend Colombia for new FIH?

    No. Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®.

    Does bioaccess® replace freelancers?

    We do not name freelancers. When the job is INVIMA registration holder / IOR, hire the operator on market-access — not only dossier coaching.

    Can I use the USD 7,500 card for an investigational device in Colombia?

    No. The public card is for already FDA-cleared or CE-marked devices. New FIH in Colombia is not recommended. For investigational import in recommended countries, use the trial IOR blog.

    Siblings?

    Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Brazil RA Consultant / ANVISA

    Next step

    Colombia RA / INVIMA search → registration operator path (not new FIH): contact bioaccess® · market-access · INVIMA checklist · INVIMA holder / IOR · CRO in Colombia (with public FIH line) · siblings Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Mexico RA Consultant / COFEPRIS; Brazil RA Consultant / ANVISA.

    Julio G. Martinez-Clark, CEO · bioaccess®

    Operator checklist sponsors still skip after hiring “RA”

    When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

    • Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
    • Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
    • Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
    • Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
    • Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
    • Country-select owner: apply the Colombia public line before anyone sells you a new INVIMA FIH from an RA search; keep Mexico, Brazil, Panama, Chile, and El Salvador on the recommended FIH conversation where the live hubs support it.
    • Commercial card owner: if the SKU is already-cleared devices, use the locked public LATAM Launch Subscription on market-access — USD 7,500/year all-in for the first device family — and do not invent freelancer comparables on this page.
    • Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

    bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This intercept is public content only. It is not leftover-site hospital FIH copy, not insurance underwriting, and not a Magical BTK page. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

  • Mexico RA Consultant / COFEPRIS Regulatory Consultant: Advice vs Execution

    General information, not legal or regulatory advice. Confirm current agency, holder, import, and post-market rules with qualified advisers. We do not invent Pure Global, freelancer, or competitor rates. Where a card is mentioned, only the locked public LATAM Launch Subscription (USD 7,500/year all-in for the first device family) already published on market-access and the holder hub applies. No unpublished client. No PHI. Always bioaccess®.

    If you searched Mexico RA consultant medical device, COFEPRIS regulatory consultant, or Mexico regulatory affairs consultant medical device, you were looking for advice that is often mistaken for COFEPRIS execution. This page owns that search intent: advice vs the operator stack. It does not name freelancers. No PHI. Always bioaccess®.

    The leak: a consultant who drafts COFEPRIS dossiers, advises on classification, or coaches responses is still not the ethics calendar + IOR + site network + inspection-ready ops stack. Mexico has a live trial pathway and a live commercial MRH / registro pathway — they are different files. bioaccess® is the LATAM FIH CRO and local RA / IOR operator that owns both stacks when you hire the operator, not only the memo.

    What the search usually means vs what execution requires

    • Search intent often means: someone who “knows COFEPRIS” for classification, registro sanitario, or investigational submission coaching.
    • Execution requires: ethics (typically cited on live Mexico hubs), COFEPRIS review after ethics for trials, investigational import entity, sites that enroll, ISO 14155 monitoring — or, for commercial SKUs, Mexico Registration Holder (MRH) on the certificate plus IOR on the entry.
    • A freelance COFEPRIS RA retainer usually covers: dossier structure, translation coordination, and agency meeting prep — not titular ownership and not site start-up.
    • Do not collapse: FDA US agent, EU AR, and MRH into one “Mexico RA” line item.

    COFEPRIS stack: trial clocks vs registro

    Use clinical-trials-mexico and CRO in Mexico. Ethics typically 4–6 weeks and COFEPRIS review typically 4–8 weeks after ethics on the live Mexico hub; combined start-up is cited there as a 2.8-month median. Keep trial clocks separate from registro sanitario (~30 working days on that hub). Eligibility of foreign data under 21 CFR 812.28 is not a guarantee of clearance. We will not invent a new COFEPRIS clock on this page.

    Commercial MRH / IOR is the holder intercept: Mexico COFEPRIS Registration Holder / IOR. Locked public card: LATAM Launch Subscription USD 7,500/year all-in for the first device family on market-access and LATAM Registration Holder and IOR. Mexico Class III / energy adders already published on that hub stay there — this page is not a second price list. Trial IOR: importer of record for clinical trial devices.

    Advice vs execution (Mexico)

    1. Classification memo ≠ submission ownership. Who signs, who pays government fees, who owns RFIs?
    2. Dossier coach ≠ MRH. Who is the Mexican legal entity on the sanitary registration?
    3. Agency etiquette ≠ ethics calendar. Institutional committees still have to sit for FIH / early feasibility.
    4. “We know importers” ≠ IOR. Who is on the customs entry for this shipment?
    5. Start-up slide ≠ inspection-ready ISF. bioaccess® runs ISO 14155 ops when you hire the CRO stack.

    Colombia line (do not leak Mexico success into Colombian FIH)

    Public line, unchanged: Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new FIH trial execution. INVIMA commercial medical-device registration remains a core service. Always bioaccess®. A clean Mexico COFEPRIS path is not a reason to book new FIH in Colombia from this page.

    How sponsors mis-buy “COFEPRIS RA”

    Three common mis-buys show up in the same search cluster. First: treating a classification opinion as if it were ethics + COFEPRIS start-up on clinical-trials-mexico. Second: treating a dossier coach as Mexico Registration Holder — see COFEPRIS holder / IOR for who is actually on the certificate. Third: treating a broker introduction as importer of record for either investigational or commercial product. bioaccess® separates those SKUs on purpose. Always bioaccess®. Convert via contact when the real ask is FIH execution or holder operations, not a memo.

    Frequently asked questions

    Is a COFEPRIS regulatory consultant a CRO?

    No. Consultant advice and CRO / holder execution are different. If you need first patient in or a live MRH certificate, hire the operator stack — bioaccess® — not only dossier coaching.

    Does bioaccess® replace freelancers?

    We do not name freelancers. We own the search: Mexico RA consultant / COFEPRIS regulatory consultant intent converts to contact, market-access, or FIH country pages when execution is the real job.

    Can the LATAM Launch Subscription run FIH?

    No. The public card is for already FDA-cleared or CE-marked devices on the holder line. Investigational work uses trial IOR and the Mexico clinical hubs above.

    Rates for freelancers or Pure Global?

    Not invented here. Only the locked public USD 7,500/year all-in card is cited when a card is mentioned.

    Siblings?

    Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA

    Next step

    Mexico RA / COFEPRIS search → operator path: contact bioaccess® · market-access · clinical-trials-mexico · CRO in Mexico · COFEPRIS holder / IOR · siblings Dominican Republic RA Consultant; Regulatory Affairs Consultant Latin America; Colombia RA Consultant / INVIMA; Brazil RA Consultant / ANVISA.

    Julio G. Martinez-Clark, CEO · bioaccess®

    Operator checklist sponsors still skip after hiring “RA”

    When the inbound query is regulatory-affairs consultant language, walk this checklist before you sign a retainer that only covers memos:

    • Ethics owner: named committee pathway, submission package owner, and response owner — with a calendar, not a vibe.
    • Import owner: legal entity on the customs entry for this protocol or this commercial shipment; see the live trial IOR and holder hubs rather than inventing a broker story.
    • Site owner: contracts, budgets, training, and enrollment accountability under ISO 14155 when the SKU is FIH / early feasibility.
    • Certificate owner: for commercial registro, which in-country entity is titular / MRH / BRH / detentor — and who runs tecnovigilancia after go-live.
    • Inspection owner: TMF/ISF discipline, monitoring, and CAPA. A classification PDF does not answer an inspector.
    • Country-select owner: apply the Colombia public line before anyone sells you a new INVIMA FIH from an RA search; keep Mexico, Brazil, Panama, Chile, and El Salvador on the recommended FIH conversation where the live hubs support it.
    • Commercial card owner: if the SKU is already-cleared devices, use the locked public LATAM Launch Subscription on market-access — USD 7,500/year all-in for the first device family — and do not invent freelancer comparables on this page.
    • Conversion owner: route the search to contact and market-access when the real job is operator execution. Always bioaccess®.

    bioaccess® is a DBA of IMH ASSETS CORP. Julio G. Martinez-Clark, Co-Founder and CEO. The founder podcast is Global Trial Accelerators™. This intercept is public content only. It is not leftover-site hospital FIH copy, not insurance underwriting, and not a Magical BTK page. Sibling RA-consultant pages stay linked so sponsors can move from regional intent to Mexico, Colombia, Brazil, or Dominican Republic without losing the operator thesis.

    Repeat the thesis in plain language for searchers who skim: hiring a freelance RA consultant is not the same as running FIH, early feasibility, or registration execution. You still need the ethics calendar, IOR/import, site network, and inspection-ready operations. bioaccess® owns that LATAM stack as FIH CRO plus local RA/IOR operator. Convert via contact and market-access. No invented rates. No named freelancers. No PHI. Always write bioaccess® with the registered mark.