Beyond Australia: Why Medtech Startups Are Re-Evaluating FIH Trial Destinations

By Julio G. Martinez-Clark, CEO, bioaccess

For the better part of a decade, the default advice handed to medtech founders planning a first-in-human (FIH) study fit in three words: go to Australia. The pitch was seductive and, for a while, mostly true. A notification-based regulatory pathway that could clear in weeks. A 43.5% refundable R&D tax offset. For a cash-constrained startup, it looked like free money on top of fast startup.

That advice is now overdue for a rewrite. Not because Australia stopped working, but because the math changed, the policy ground is moving, and founders finally have real alternatives. Here's the honest comparison nobody puts in a pitch deck.

What Australia Actually Sells

Australia's speed advantage comes from the Clinical Trial Notification (CTN) scheme. Under CTN, the sponsor notifies the Therapeutic Goods Administration that the trial involves an unapproved product — and the TGA explicitly does not evaluate any data about the trial at the time of notification.¹ The scientific and ethical review is delegated to a National Health and Medical Research Council (NHMRC)-registered Human Research Ethics Committee (HREC). Once the HREC approves, the site's approving authority signs off, and the TGA acknowledges the notification, the trial can begin.

That is genuinely fast — but notice what it is not. It is not a regulatory review. The timeline is set by the ethics committee, not the TGA, and committee timelines vary by institution and workload. Sponsors who hear "fast approval" and budget accordingly are sometimes surprised to learn the ethics review is the long pole, not the notification.

The Red Tape Behind The "Fast" Lane

Australia's reputation for speed rests on a single fact: the TGA notification itself is fast. Everything around it is another story — and the system around it is where startups actually live.

The pattern repeats: a device startup plans its Australian first-in-human, and the process — not the science — is what stalls it. The ethics committee's assessment becomes the practical gate, the hospital adds its own governance queue and renegotiates per-procedure costs, and a startup measuring runway in months runs out of calendar before it runs out of money.

Here's what the brochures don't show. Under the TGA's own rules, "an overseas company cannot be the sponsor of a trial in Australia."² That last point deserves honesty: Latin American regulators also require a local sponsor or legal representative, and a clinical research organization (CRO) typically fills the role in both regions. The difference is the tax structure Australia requires to capture the rebate, not the regulatory one. Researchers writing in the Medical Journal of Australia (MJA)'s InSight+ describe the ethics layer as "inconsistent and inefficient — leading to delays, especially for studies involving multiple sites," with institutions redoing the lead committee's review for lack of confidence in it, on multiple application platforms across states and territories, despite a national mutual-acceptance scheme meant to prevent duplicate review.³ Then comes the hospital layer: site-specific governance assessments and renegotiated per-procedure costs "can potentially add months to the hospital approval process"⁴ — a problem the Commission's new governance standards are meant to address. This isn't a critics' talking point — a Senate select committee found in 2018 that governments "could reduce the red tape associated with clinical trials, by standardising and harmonising the ethics approval process."⁵

Now compare the current Latin American reality. Brazil's 2024 clinical trials law (Law 14,874/2024, in force since August 2024) caps initial ethics review at 30 business days and, for device studies requiring authorization from Brazil's ANVISA (Agência Nacional de Vigilância Sanitária) under RDC (Resolução da Diretoria Colegiada) 837/2023, caps ANVISA's review at 90 business days, with the two tracks running in parallel.⁶ That is a statutory ceiling, not a demonstrated median: pre-law device reviews ran 120–180 days in my experience, and real-world performance under the new system is still being proven. (The caveat the law doesn't fix: in my experience, importing investigational devices can take four weeks to five months through customs, and that clock runs outside the approval timelines.) El Salvador's regulator-plus-ethics review typically runs about 60 days in my experience, with first patient generally 3–5 months from submission.⁷ Chile is the region's thinnest regime for devices. The Sanitary Code (art. 111A) requires both accredited ethics-committee approval and an ISP (Instituto de Salud Pública) "autorización especial para uso provisional" for the unregistered device; ANDIM (Agencia Nacional de Dispositivos Médicos, the ISP's medical-device agency) has notified to the WTO (World Trade Organization) a draft procedure guide for that authorization that is not yet in force,⁸ and issued a non-binding guide to good clinical practice for device investigations in April 2026.⁹ In practice the ethics committee performs the substantive scientific review, but the ISP authorization is a statutory step and must be obtained. Sponsors must still price the Code's device-applicable obligations — post-trial treatment continuity (art. 111C) and presumed liability with a ten-year window (art. 111E) — into the study. And the 2026 reform (Exempt Decree 25, March 2026) hardens commercial registration, not trial authorization — it does not close this gap.¹⁰ And Panama's pathway has been used in practice — most recently in August 2026, when Nanochon received Ministry of Health approval to start its first-in-human Chondrograft study at The Panama Clinic in Panama City.¹¹ A 2019 review by a global CRO found that "the reduction of regulatory approval timelines" is "already leading to a greater number of clinical trials in the region."¹² In these jurisdictions a sponsor deals with a process designed for the purpose — not a federation of committees re-litigating one another's decisions.

None of this means Australia can't work. It means the "fast Australia" story confuses a fast notification with a fast system. For a startup that needs its first patient dosed this year, the system is the part that matters.

The Rebate Is Real. Read The Fine Print.

The R&D Tax Incentive's 43.5% refundable offset is the other half of the pitch: spend on eligible R&D in Australia, get nearly half of it back as a cash refund. For pre-revenue startups, that is real money.¹³

But four details rarely make the sales conversation:

Cash timing. The offset is claimed retrospectively: activities are registered with AusIndustry within 10 months of the financial year ending, the offset is claimed in that year's company tax return, and the ATO (Australian Taxation Office) pays the refundable amount only once the return is processed.¹³ Run that arithmetic and the cash lands 12–24 months after the spend. You fund the trial first, in full, and the rebate lands long after the runway decisions were made. For a startup managing cash in weeks, a refund 12–24 months after the spend is not the same as a discount.

Structure. You need a qualifying Australian presence — in practice, an Australian-incorporated subsidiary — and the offset's generosity depends on turnover thresholds. Setting up and administering that structure — entity, registrations, claims, documentation — is its own project with its own costs.

Eligibility risk. Claims must satisfy "core R&D" definitions with contemporaneous documentation. The program has a long history of compliance reviews, and aggressive claims get unwound.

The rebate refunds a premium; it doesn't create a discount. Do the arithmetic the pitch decks skip. Australian site and hospital costs sit in the expensive tier: IMS Health's cost-per-visit data groups Australia/New Zealand with the US, Canada, and Western Europe as established regions, with Latin America "starting off on a lower base" — 2011–2013 data, and the gap has narrowed since, but the direction holds.¹⁴ Australia's own hospital-costing authority costed a single ethics review at A$2,099 and trial-coordinator time at A$91 an hour — and those are 2014–15 figures.¹⁵ Part of the gap is structural, not monetary: Australian hospitals price procedures in a high-wage economy, while Latin American sites price the same work at local wage levels. Exchange rates move; the wage gap doesn't. In my experience building these budgets, applying the 43.5% offset to Australia's eligible cost base lands the net in the same neighborhood as Latin America's day-one price. That's parity, not savings — and parity that arrives 12–24 months after the spend, after you've funded an Australian presence and defended an R&D claim to collect it. A cost advantage that only exists after a tax return isn't a cost advantage.

The 2028 redesign. This is the one that changed the conversation. In the 2026–27 budget, handed down in May 2026, the government announced a full reshape of the incentive, announced to take effect July 1, 2028.¹⁶ The exposure draft legislation released in September fleshes out the detail. As drafted, it would raise headline offset rates but limit refundability to a company's first ten years — extended to fifteen for biotech and medtech firms, an explicit acknowledgment of how long development takes — introduce a higher minimum spend threshold, and remove supporting R&D expenditure from eligibility.¹⁷ The draft is not yet law and may change in Parliament. Even before the draft was released, Australia's own life sciences industry — a coalition of its medical research institutes and biotech and medtech associations — warned in July that "while the changes aren't due to take effect until 2028, they are already influencing decisions" about where trials and investment go.¹⁸ Founders plan on three-to-five-year horizons. A founder choosing a trial site today is choosing under tomorrow's rules.

The Quiet Costs

Beyond the policy layer sit the operational realities. Australia has about 27 million people concentrated in a handful of cities — fine for a 15-patient safety study, harder when you need to enroll quickly or expand. And the "Australia discount" that once came from a favorable exchange rate is not a strategy; currencies move.

Then there is the travel nobody budgets honestly. Running a trial means bodies on planes: site search and selection visits, prequalification visits, investigator meetings, monitoring trips — and a startup typically sends three people, not one. In a first-in-human device study it goes further, because the sponsor team usually flies in for every procedure. Ten to twenty patients can mean ten to twenty procedure trips, each carrying three to five people. From New York, Sydney is a 24-hour journey each way, with economy fares typically running $500 to $1,500 one-way.¹⁹ Run that arithmetic — a dozen procedure trips at four travelers each — and airfare alone lands in the high five to low six figures, before a single hotel night, per diem, or lost workday, paid up front in cash whatever the rebate eventually returns. From Miami, Bogotá — still our regional hub — is about four hours and 1,500 miles, with one-way fares typically $155 to $515.18 (fares as of October 2026)²⁰ — same-day or next-day access, in time zones that overlap US working hours instead of forcing your team to manage the study overnight.

None of this makes Australia a bad choice. It makes it a choice with a price tag that deserves the same scrutiny as any other.

The FDA Question Is Settled

The objection that kept many US sponsors from looking elsewhere — "the FDA won't accept foreign data" — is settled law, not settled opinion. FDA codified its conditions for accepting foreign device data in 21 CFR (Code of Federal Regulations) 812.28 — a rule published in February 2018 and effective February 21, 2019, implementing a mandate Congress enacted in the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012. FDA had accepted OUS (outside the United States) device data before then; 812.28 standardized the conditions: good clinical practice, independent ethics-committee review, and the required supporting statements.²¹ The agency's guidance is explicit: what matters is design quality, Good Clinical Practice (GCP) compliance, independent ethics oversight, and data integrity — all achievable anywhere on earth, provided the data are applicable to the US population and practice of medicine — which is a protocol-design question, not a geography question.²² The sponsors still citing FDA risk as a reason to default to Australia are fighting the last war.

Where Latin America Competes

This is the part of the map most US founders have never seriously examined, and it is where the comparison gets interesting. The advantages are concrete:²³

Speed. Faster ethics and regulatory approvals, leading to quicker time-to-first-patient — often four to six months.²⁴ In my experience, Costa Rica, El Salvador, Chile, and Panama are consistently the fastest regulatory environments in the region for early-stage work (with the caveat that Costa Rica's framework, Ley 9234, has been exercised mostly for drug studies, making it the least device-tested of the four).

Cost-effectiveness. Significantly lower per-patient costs than the US or EU²⁵ — the sticker price, not a net-after-rebate figure that takes 12–24 months after the spend to materialize. For a startup, a dollar not spent beats a dollar refunded 12–24 months after the spend, and the savings extend runway directly.

Operational simplicity. Streamlined processes and teams with a dedicated focus on FIH trials. Large, treatment-naïve populations and concentrated urban centers mean enrollment curves that Australia's smaller population cannot always match.²⁴ US time zones, direct flights from Miami and Houston, and investigator teams accustomed to working to FDA expectations under GCP²⁶ — the friction of running the study, the part that consumes your team's actual weeks, drops sharply.

Reduced overhead. No Australian-style tax structure to set up and administer — the local-representative role that every jurisdiction requires is filled by the CRO, as it can be in Australia. You run the trial; you don't administer a structure around it.

FDA-anchored design. The strongest regional programs design the FIH study from day one as the opening chapter of the US regulatory strategy: GCP compliance, independent ethics review, and data packages built for 812.28 acceptance and pre-submission meetings — not as an isolated offshore experiment.

One country we currently keep off our first-choice FIH shortlist: Colombia. Its health regulator, INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), runs a workable device pathway and remains a strong market for later-stage and registration work, but in my experience, since 2022, review timelines for investigational-device studies have been less predictable than in Panama, El Salvador, or Chile. That may change — a reform wave is building (see below) — but as of this writing I do not lead with it for FIH. Bogotá remains our operations hub, even though we route most FIH work elsewhere.

An unprecedented reform wave. Step back from the country-by-country snapshot and the pattern is unmistakable: Latin America is rewriting its clinical research rulebooks in real time, and no previous decade has arguably seen this many of the region's regulators moving at once. Colombia is the clearest example. In 2025 its Congress took up Bill 191, a clinical-research bill under which minimal-risk studies would need only ethics-committee approval, with INVIMA notified afterward rather than asked for permission first²⁷ — a direct answer to the predictability complaint that has kept sponsors cautious. That bill was archived on June 20, 2026, when the legislative term expired before a first-debate vote.²⁸ But the idea did not die: on September 16, 2026, a new INVIMA modernization bill (PL 250/26) was formally filed in the Senate,²⁹ and it would go further. Formal regulatory reliance on World Health Organization (WHO)-listed and PAHO (Pan American Health Organization)-recognized reference authorities, risk-based review, consolidated information requests, and — for the first time — published, quarterly-reported performance timelines, with mandatory improvement plans when targets are missed. It is a bill, not yet law; but for a sponsor choosing a jurisdiction, the direction of travel is the data point that matters. And there is a parallel executive track: Colombia's MINSALUD (Ministerio de Salud y Protección Social) draft resolution modernizing Resolución 8430 de 1993 (the health-research rulebook in force since 1993) completed a second public consultation on August 4, 2026.³⁰ As drafted, it replaces 8430's one-size-fits-all ethics regime with a risk-based system: staged ethics-committee evaluation, with formal risk matrices only for higher-than-minimal-risk studies. INVIMA would retain authorization and risk-reclassification power over clinical trials, medical devices included. And all human research would gain a mandatory national registry with prospective WHO ICTRP (International Clinical Trials Registry Platform)-linked trial registration.³¹ It is still a draft, not yet issued. Because it rests on existing ministerial authority rather than new legislation, it moves on its own clock, independent of the bills.³² Note what it does not do: it sets no hard statutory review clocks; that piece would have to come from the legislative track.³¹

Brazil has already crossed the finish line. Law 14,874/2024 gave the country its first statutory framework for clinical research with human beings, a single ethics review for multicenter studies and hard statutory review clocks.⁶ In November 2024, ANVISA approved a sweeping modernization of its clinical research rules (for drug trials), built explicitly around cutting bureaucracy and relying on equivalent foreign authorities.³³

Paraguay joined the wave in September 2024, when Paraguay's DINAVISA (Dirección Nacional de Vigilancia Sanitaria) issued Resolution 238/2024, the country's first GCP-aligned framework for authorizing and overseeing clinical trials of medicines, vaccines, medical devices, and diagnostics, developed with PAHO/WHO technical support.³⁴

Costa Rica has modernized at the operational level: in April 2025 Costa Rica's CONIS (Consejo Nacional de Investigación en Salud) issued the third version of its protocol-review procedure for interventional and observational studies.³⁵

Mexico's package may be the deepest in the region: in March 2025 Mexico's COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) published a reliance agreement giving protocols already approved by WHO-listed high-recognition agencies (the European Medicines Agency, FDA, the United Kingdom Medicines and Healthcare products Regulatory Agency, and Health Canada) an international reliance path, and COFEPRIS stated that protocol authorization times fell from 90 days in 2024 to 45 days in early 2025.³⁶

Ecuador modernized its clinical trials framework at the end of 2024, issuing Acuerdo Ministerial 00069-2024 (signed December 31, 2024; published in Registro Oficial 730 on January 27, 2025) on trials with medicines and processed natural products (drug-focused), building on the country's dedicated clinical trials regulation in place since 2017 (Acuerdo Ministerial 0075-2017).³⁷

Argentina replaced its 2011 GCP regime with ICH (International Council for Harmonisation) E6(R3) in Argentina's ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) Disposición 7516/2025 (for drug studies),³⁸ and Chile's ISP approved the country's first device-specific clinical investigation guidance (non-binding) in April 2026.⁹

Cuba, too, joined the wave: in July 2025 Cuba's CECMED (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos) enacted Regulation E 132-25, a device policy that embraces reliance on other agencies' decisions and defines when clinical investigations serve as market-authorization evidence.³⁹

El Salvador replaced its old medicines directorate with an entirely new autonomous regulator: the Superintendencia de Regulación Sanitaria (SRS), effective August 2024,⁴⁰ and its first dedicated clinical trials bill (Expediente 255-1-2025-1), which earned a favorable committee opinion in 2025 but has not yet been enacted, names medical devices and equipment explicitly.⁴¹ SRS's proposed October 2025 update to its GCP-inspection guide would apply to device trials and cites ISO (International Organization for Standardization) 14155 (clinical investigation of medical devices for human subjects — good clinical practice).⁴²

Panama, seven years after its 2019 law, issued the first implementing regulation for its ethics-committee and protocol-registration regime (Decreto Ejecutivo 21, April 2026), formalizing the sequence every protocol must follow — Panama's MINSA (Ministerio de Salud) registration first, then ethics review — and putting the country's first hard clocks on it. Ethics review is now capped at 10, 20, or 30 business days depending on review type, with MINSA's technical evaluation running in parallel.⁴³

The wave even reached the region's smaller states: in June 2025 the Dominican Republic restructured CONABIOS (Consejo Nacional de Bioética en Salud) by decree (351-25), establishing its structure and competencies over human research — device studies included — and its Resolution 03-25 made ethics-committee certification mandatory effective September 1, 2026.⁴⁴ And Honduras may be the most device-relevant reform of the bunch: Acuerdo 0256-ARSA-2025 (ARSA, Agencia de Regulación Sanitaria), in force since April 2026, is a fully device-inclusive trial framework with a dedicated device chapter, published fee tables tied to 15/30/60/120-day review tiers, mandatory participant insurance, and six-authority reliance including TGA and Japan's PMDA (Pharmaceuticals and Medical Devices Agency).⁴⁵

Put Colombia's new bill next to these enacted overhauls and the trajectory is clear: the region that competes on speed today is legislating to be faster tomorrow. When your board asks what the rules will look like in three years, that is the answer.

Retention, And The Ethics That Make It Legitimate

The ethical guardrails come first, because they matter more here, not less. Every study we support is reviewed by an independent ethics committee for undue influence and equitable subject selection. Consent is obtained under ISO 14155 (clinical investigation of medical devices for human subjects — good clinical practice) and the Declaration of Helsinki: every participant is informed, as ISO 14155 §5.8 and the Declaration of Helsinki require, that the study is research rather than treatment, that participation is voluntary, and that they may withdraw at any time without losing access to care. Where local law or the protocol requires post-trial access, that is built into the budget from day one.

Here is the enrollment dynamic that deserves plain discussion. In Australia, Medicare — universal since 1984 — gives residents access to a wide range of services at little or no cost.⁴⁶ A trial is one option among many. In much of Latin America, access to specialist care is uneven, and patients place real value on the close clinical attention a well-run trial provides.

Within those guardrails, the operational fact is this: engaged patients who value the relationship with their investigator keep follow-up appointments, and retention is a data-quality issue, not just a timeline issue. Anyone who has managed enrollment on both continents knows the difference. This advantage does not depend on exchange rates or tax policy, but it does depend on running the study to a standard that would satisfy any US institutional review board (IRB). That is the non-negotiable.

A Framework For The Board Meeting

Geography is a strategy decision, not a narrative one. When your board asks where the FIH goes, make them answer these six questions:

1. What is our cash position relative to rebate timing? If runway is the constraint, money today beats money 12–24 months after the spend.
2. How fast can we enroll? Model enrollment on population, site capacity, and patient motivation — not on regulatory theory.
3. Does the team need to be on-site? Price the travel and the time-zone drag honestly.
4. What is the FDA strategy? If the answer is "we'll figure it out after FIH," the site decision is premature wherever it lands. Design for 812.28 acceptance from the protocol's first draft.
5. Who owns the data chain? GCP compliance, monitoring, and audit readiness matter more than the flag on the clinic.
6. What do the rules look like in three years? Australia's 2028 redesign is a reminder: pick the jurisdiction whose trajectory favors you, not just whose current brochure does.

Australia earned its reputation. But reputations are lagging indicators. The founders re-evaluating their FIH destinations today are not chasing a trend — they are doing what good founders do: repricing an old default against new information. The LinkedIn narrative says Australia. The spreadsheet, increasingly, says: look to Latin America.

Editor's note: this column is general information, not legal or regulatory advice; sponsors should confirm requirements with local regulatory counsel.

References

1. Therapeutic Goods Administration. Clinical Trial Notification (CTN) scheme. https://www.tga.gov.au/products/unapproved-therapeutic-goods/access-pathways/clinical-trials/clinical-trial-notification-ctn-scheme
2. Therapeutic Goods Administration. Australian Clinical Trial Handbook. https://www.tga.gov.au/resources/guidance/australian-clinical-trial-handbook
3. InSight+. (2025, November). Why do human research ethics committees need quality standards? InSight+ (Australasian Medical Publishing Co.). https://insightplus.mja.com.au/2025/11/why-do-human-research-ethics-committees-need-quality-standards/
4. Australian Commission on Safety and Quality in Health Care. New minimum standards to apply for clinical trials in Australia. https://www.safetyandquality.gov.au/newsroom/external-publications/new-minimum-standards-apply-clinical-trials-australia
5. Senate Select Committee on Red Tape. Interim report: Effect of red tape on health services. Parliament of Australia. https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Red_Tape/HealthServices/
   ~/media/Committees/redtape_ctte/HealthServices/Interim_Report/c02.pdf
6. Lexology. Does Law #14,874 address the obstacles that prevented Brazil from becoming a hub for clinical research? (Art. 14: 30 business days for ethics-committee opinion; Art. 58: 90 business days for ANVISA health analysis.) https://www.lexology.com/library/detail.aspx?g=2295f2f0-7b43-4753-bc0a-46e66a59cf9e (Law text (Planalto): https://www.planalto.gov.br/ccivil_03/_Ato2023-2026/2024/Lei/L14874.htm)
7. Med Device Online. The Landscape of Medtech Clinical Research in El Salvador. (author's prior column) https://www.meddeviceonline.com/doc/the-landscape-of-medtech-clinical-research-in-el-salvador-0001
8. World Trade Organization. G/TBT/N/CHL/796 — Chile: draft 'Guía de Autorización de Uso Provisional' under Sanitary Code Article 111A (ANDIM procedure for ISP 'autorización especial para uso provisional'); notified as a draft technical regulation (TBT Art. 2.9.2), adoption and entry-into-force fields blank — not in force. ePing. https://www.epingalert.org/es/DOL/GetDocument?dolLink=G/TBTN26/CHL796¬ificationId=113734
9. Instituto de Salud Pública de Chile. Resolución Exenta E2050 (16 April 2026) — Aprueba 'Guía de Investigación Clínica de Dispositivos Médicos en Humanos. Buenas Prácticas Clínicas' (first device-specific clinical-investigation guidance; non-binding). Diario Oficial extract (published 7 May 2026): https://www.litoralpress.cl/SimbiuPDF/2026/05/07/6636902.pdf
10. Instituto de Salud Pública de Chile. Normativa ANDIM — medical devices and in-vitro diagnostic devices brought under the sanitary-control regime of article 111 of the Sanitary Code by Decreto Exento N° 25 de 2026, Ministerio de Salud (published in the Diario Oficial, 6 March 2026). https://www.ispch.cl/normativa-andim/
11. Nanochon. (2026, August 14). Nanochon Receives Regulatory Approval from Panamá's Ministry of Health to Initiate First-in-Human Clinical Study of Chondrograft™. PR Newswire. https://www.prnewswire.com/news-releases/nanochon-receives-regulatory-approval-from-panamas-ministry-of-health-to-initiate-first-in-human-clinical-study-of-chondrograft-302851955.html
12. PPD. (2019, October). Positive changes in the Latin American regulatory environment. Regulatory Rapporteur. https://www.ppd.com/wp-content/uploads/2020/01/2019-Oct-Regulatory-Rapporteur-Latin-America-Regulatory.pdf
13. Australian Government. R&D Tax Incentive. https://business.gov.au/Grants-and-Programs/Research-and-Development-Tax-Incentive/
14. IMS Health / Applied Clinical Trials. Cost Per Visit Trends Higher for Less Established Regions. Applied Clinical Trials. https://www.appliedclinicaltrialsonline.com/view/cost-visit-trends-higher-less-established-regions
15. HealthConsult Pty Ltd for the Independent Hospital Pricing Authority. (2015, June 23). Development of a table of standard costs for conducting Clinical Trials in Australia 2015 — Final Report. https://www.ihacpa.gov.au/sites/default/files/2022-02/Development%20of%20a%20table%20of%20standard%20costs%20for%20conducting%20
    clinical%20trials%20in%20Australia.pdf
16. Australian Government. (2026, May 12). Budget Paper No. 2: Budget Measures 2026–27 — Tax Reform: better targeting the Research and Development Tax Incentive. https://budget.gov.au/content/bp2/download/bp2_02_receipt_payment.pdf
17. The Treasury. (2026, September). Exposure draft legislation — tax reforms to support research and development. Ministers' media release. https://ministers.treasury.gov.au/ministers/jim-chalmers-2022/media-releases/exposure-draft-legislation-tax-reforms-support
18. AusBiotech et al. (2026, July). Australia's medical and science industry unites to raise concerns about proposed R&D tax changes. News Hub. https://newshub.medianet.com.au/2026/07/australias-medical-and-science-industry-unites-to-raise-concerns-about-proposed-rd-tax-changes/160413/
19. Expedia. Flights from New York (JFK) to Sydney (SYD): fastest flight duration around 23 hours non-stop; typical one-stop journeys about 24 hours total; one-way economy fares typically $495–$1,530. https://www.expedia.com/lp/flights/jfk/syd/new-york-to-sydney
20. Expedia. Flights from Bogotá (BOG) to Miami (MIA): fastest flight duration around 4 hours non-stop; route distance roughly 1,500 miles; one-way economy fares typically $155–$515. http://www.expedia.com/lp/flights/bog/mia/bogota-to-miami
21. 21 CFR 812.28. Acceptance of data from clinical investigations conducted outside the United States. https://www.govinfo.gov/content/pkg/CFR-2024-title21-vol8/pdf/CFR-2024-title21-vol8-sec812-28.pdf
22. U.S. Food and Drug Administration. Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions — Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/media/111346/download
23. Clinical Leader. (2022, July 5). Latin America's Landscape for Medtech Clinical Trials. (author's prior column) https://www.clinicalleader.com/doc/latin-america-s-landscape-for-medtech-clinical-trials-0001
24. Med Device Online. Latin America Is Becoming The Testing Ground For AI-Enabled Medical Device Clinical Trials. (author's prior column) https://www.meddeviceonline.com/doc/latin-america-is-becoming-the-testing-ground-for-ai-enabled-medical-device-clinical-trials-0001
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27. Colegio Médico Colombiano / Epicrisis. Análisis del Proyecto de Ley 191 de 2025: avances y desafíos para la investigación clínica. (April 28, 2026). https://epicrisis.org/2026/04/28/proyecto-de-ley-191-de-2025-avances-y-desafios-para-la-investigacion-clinica/
28. Cámara de Representantes de Colombia. Proyecto de Ley 191 de 2025 Cámara — Investigación clínica con seres humanos; archived June 20, 2026, for passage of the legislative term, without reaching a first-debate vote. https://www.camara.gov.co/investigacion-clinica-con-seres-humanos-172/
29. Senado de la República de Colombia. Proyecto de Ley 250/26 — Modernización del INVIMA; filed September 16, 2026, pending committee assignment. https://leyes.senado.gov.co/p-ley/2026-2027/PL%20250-2026-%20MODERNIZACION%20INVIMA.pdf
30. Ministerio de Salud y Protección Social (Colombia). Draft resolution on administrative requirements for human health research (second public consultation, July 29–August 4, 2026; not yet issued). Normativa — proyectos de actos administrativos. https://www.minsalud.gov.co/Normativa/Paginas/proyectos-actos-administrativos.aspx
31. Ministerio de Salud y Protección Social (Colombia). Draft resolution text (50 pp., second consultation) — risk-based ethics-committee evaluation (Art. 25); INVIMA authorization and risk-reclassification of clinical trials including medical devices (Art. 43); mandatory national registry PNRIS and prospective WHO ICTRP-linked trial registration (Art. 49). https://aciccolombia.org/wp-content/uploads/2026/07/Proyecto-de-Resolucion-Investigacion-en-Salud-para-Publicar-segunda-consulta.pdf
32. Ministerio de Salud y Protección Social (Colombia). Memoria justificativa (February 6, 2026). https://www.minsalud.gov.co/Anexos_Normatividad_Nuevo/Memoria%20Justificativa%20Resol
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33. ANVISA. (2024, November 28). Anvisa aprova novo marco para regras de pesquisa clínica no país. Agência Nacional de Vigilância Sanitária. https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-aprova-novo-marco-para-regras-de-pesquisa-clinica-no-pais
34. PAHO/WHO. (2024, September 30). Paraguay da un paso más hacia las Buenas Prácticas Clínicas (BPC). Organización Panamericana de la Salud. https://www.paho.org/es/noticias/30-9-2024-paraguay-da-paso-mas-hacia-buenas-practicas-clinicas-bpc
35. CONIS. (2025, April 2). Procedimiento de revisión de protocolos intervencionales y observacionales para inscripción del Consejo Nacional de Investigación en Salud (CONIS), Versión 3, Sesión 19. Ministerio de Salud, Costa Rica. https://conis.ministeriodesalud.go.cr/index.php/biblioteca-de-archivos/documentos-conis/servicios/requisitos-acreditaciones/procedimientos/79-procedimiento-inscripcion-de-protocolos-intervencionales-y-observacional-2025/file
36. COFEPRIS. COFEPRIS reduce en 60% el tiempo de aprobación de protocolos de investigación clínica gracias a la digitalización — acuerdo (DOF, 24 March 2025) establishing criteria for authorizing research protocols previously authorized by WHO-listed high-recognition agencies; COFEPRIS stated protocol authorization times fell from 90 days in 2024 to 45 days in early 2025. http://www.gob.mx/cofepris/articulos/cofepris-reduce-en-60-el-tiempo-de-aprobacion-de-protocolos-de-investigacion-clinica-gracias-a-la-digitalizacion
37. Ministerio de Salud Pública del Ecuador. (2025, February 3). MSP presentó normativa para regular ensayos clínicos en Ecuador — Acuerdo Ministerial Nro. 00069-2024. https://www.salud.gob.ec/msp-presento-normativa-para-regular-ensayos-clinicos-en-ecuador/
38. ANMAT. Disposición 7516/2025 (DI-2025-7516-APN-ANMAT#MS). Normas sobre Buenas Prácticas Clínicas de estudios de farmacología clínica con fines registrales; adopta ICH E6(R3). Boletín Oficial de la República Argentina, 9 October 2025. https://www.boletinoficial.gob.ar/#!DetalleNorma/332695/20251009
39. CECMED. Regulación E 132-25 — Resolución No. 63/2025 (23 July 2025); device policy embracing reliance on other agencies' decisions and defining when clinical investigations serve as market-authorization evidence. Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos, Cuba. https://www.cecmed.cu/reglamentacion/ambito-regulador/indice?page=2%2C13
40. Asamblea Legislativa de El Salvador. Superintendencia de Regulación Sanitaria — creation as autonomous regulator (effective August 2024), functions including medical devices and clinical-trial oversight. https://www.asamblea.gob.sv/node/13206
41. Asamblea Legislativa de El Salvador. Comisión de Salud respalda iniciativa de ley para regular ensayos clínicos en el país — Health Commission favorable opinion on the dedicated clinical-trials bill (Expediente 255-1-2025-1); covers medical devices explicitly; not yet enacted. https://www.asamblea.gob.sv/node/13486
42. Organismo de Mejora Regulatoria (El Salvador). Dictamen OMR_GEIRSA-DF/042/2025 — propuesta de actualización de la 'Guía de Inspección para la evaluación de Buenas Prácticas Clínicas,' Superintendencia de Regulación Sanitaria (2025). https://omr.gob.sv/2022/06/27/direccion-nacional-de-medicamentos-eir/
43. Ministerio de Salud de Panamá. Decreto Ejecutivo N. 21 (23 April 2026) — first implementing regulation for the ethics-committee and protocol-registration regime under Law 84 of 2019 (Titles III and IV); hard review clocks of 10, 20, or 30 business days. https://www.minsa.gob.pa/node/10704
44. Presidencia de la República Dominicana. Decreto No. 351-25 (30 June 2025) — restructures CONABIOS (Consejo Nacional de Bioética en Salud), establishing its structure and competencies over human research, device studies included. CONABIOS Resolución No. 03-25 (26 August 2025) made ethics-committee certification mandatory effective 1 September 2026. https://conabios.gob.do/ — https://diariosalud.do/conabios-comites-etica-certificados-protocolos-investigacion/
45. ARSA Honduras. Acuerdo 0256-ARSA-2025 — fully device-inclusive clinical-trial framework with dedicated device chapter, published fee tables (15/30/60/120-day tiers), mandatory participant insurance, six-authority reliance. Agencia de Regulación Sanitaria. (In force April 2026.) https://arsateca.arsa.hn/wp-content/uploads/2026/02/Acuerdo-0256-ARSA-2025.pdf
46. Australian Government. (2025). Understanding Medicare: Provider Handbook. Department of Health, Disability and Ageing. https://www.health.gov.au/sites/default/files/2025-09/understanding-medicare-provider-handbook.pdf

About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the Global Trial Accelerators podcast. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).