Category: Advantages of Conducting Trials in Latin America

If you typed Visionware Clinical into a search box, you are probably building a CRO shortlist. This article uses only what Visionware Clinical publishes (visionwareclinical.com · visionwareclinical.com/services · visionwareclinical.com/about-us) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Visionware Clinical publishes

Visionware Clinical is a Sydney-area (Mosman, NSW) contract research organisation that calls itself an emerging CRO in Australia and New Zealand specialising in medical devices. Its services page covers consulting, data gathering, medical writing, clinical trials and regulatory work. It says it will help design and conduct first-in-human, feasibility and pivotal trials, set up paper or electronic data capture, and support ARTG registration with the TGA. It also advises on Australia's R&D tax incentive and on setting up a local entity. Dina Peleg Kowarski is CEO and Director of Clinical Operations, with more than 15 years in clinical trials. We found no named sponsor or study on its site.

Visionware Clinical vs bioaccess®

Dimension	Visionware Clinical	bioaccess®
Core focus	Boutique Australian medical-device CRO	First-in-human and early feasibility studies for medical devices
Geography	Australia and New Zealand	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	ARTG registration support with the TGA and post-market clinical trials, per its services page	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you want a small device-only team for a first Australian feasibility study, with ARTG support afterwards, Visionware publishes that offer.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Visionware Clinical, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Visionware Clinical features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Visionware Clinical public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Scientia Clinical Research into a search box, you are probably building a CRO shortlist. This article uses only what Scientia Clinical Research publishes (www.scientiaclinicalresearch.com.au · www.scientiaclinicalresearch.com.au/about-scientia · www.scientiaclinicalresearch.com.au/our-experience · www.scientiaclinicalresearch.com.au/sponsors) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

What Scientia Clinical Research publishes

Scientia Clinical Research is a not-for-profit Phase 1 unit in Randwick, Sydney, incorporated in 2015 and based in the Bright Building on the Randwick health precinct. It has a long-term lease with South Eastern Sydney Local Health District and a service agreement with Prince of Wales Hospital for emergency support, and calls itself the only purpose-built first-in-human Phase 1 unit in central Sydney run as a not-for-profit. It claims 300+ studies completed, 24/7 participant monitoring, in-house ethics and start-up specialists, and experience in SAD/MAD, food-effect, drug-interaction, PK, biosimilar, vaccine and Phase 1 oncology studies. Its experience page lists "First In Human Medical device studies" among its capabilities, but we found no named device sponsor on the pages reviewed.

Scientia Clinical Research vs bioaccess®

Dimension	Scientia Clinical Research	bioaccess®
Core focus	Not-for-profit drug Phase 1 unit; device FIH listed as a capability	First-in-human and early feasibility studies for medical devices
Geography	Australia	Latin America, since 2010
Device FIH track record	No named device first-in-human study found on the public pages reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Live multi-country sanitary registration and in-country holder service

Where each one fits

If you need a Sydney Phase 1 unit for a drug, a biologic, or a device study that can run under Phase 1 confinement, Scientia is a credible choice.

If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Scientia Clinical Research, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Scientia Clinical Research features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts from the Scientia Clinical Research public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

If you typed Precision for Medicine (New Zealand) into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what Precision publishes (Precision for Medicine: New Zealand Clinical Trial Landscape (21 Nov 2025)) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.

What Precision publishes

Precision for Medicine says New Zealand runs “about 20-25% of Australia’s” trial load and “can start even faster than Australia, including in First-In Human (FIH) studies”. It cites 4–6 weeks from ethics submission to trial start, no IND, and 30–50% lower costs than the U.S. It also lists Medsafe “approval time of 45 days”. Medsafe’s current guideline gives a target of 32 working days for drug trial applications, and device trials don’t need Medsafe approval at all. The article names New Zealand early-phase sites but doesn’t describe Precision’s own device first-in-human studies there.

Precision vs bioaccess®

Dimension	Precision	bioaccess®
Core focus	Global CRO, oncology and precision-medicine led	First-in-human and early feasibility studies for medical devices
Geography	Global, including Australia and New Zealand	Latin America, since 2010
Device FIH track record	Not covered in the New Zealand article	Published case studies on bioaccessla.com
After the trial	See provider site	Multi-country sanitary registration and in-country holder service

Where each one fits

For biomarker-heavy oncology or early-phase drug programs spanning Australia and New Zealand, Precision’s model makes sense.

If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Precision, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.

New Zealand offers real country advantages:
– device trials need HDEC ethics approval but no Medsafe approval;
– one ethics review covers all sites;
– HDEC aims to decide within 15 days (expedited review) or 35 days (full review).

Those advantages belong to the country, not to Precision. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.

Frequently asked questions

How long does Medsafe take to approve a trial?

For new medicines, Medsafe’s guideline targets an outcome within 32 working days of receiving the application, once fees are paid. Medical device trials need HDEC ethics approval but no Medsafe approval.

Does a device trial in New Zealand need Medsafe approval?

No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).

Can Latin American device data support an FDA submission?

Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.

When is bioaccess® the better choice than Precision?

When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts come from the Precision public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.

If you typed Novotech (New Zealand) into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what Novotech publishes (Novotech: Why New Zealand Is Emerging as a Clinical Trial Hub (3 Feb 2025)) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.

What Novotech publishes

Novotech promotes New Zealand as a “high-quality, cost-efficient hub for early-phase and innovative clinical research”. It says trials “can typically begin within 4–6 weeks of ethics submission”, with “no need for IND approval for most early-phase studies”, and that New Zealand can be “30–50% more cost-effective” than the U.S., plus a 15% R&D tax credit. It positions New Zealand as “a pilot study location before expanding globally” and “a back-up country”. The article focuses on oncology, vaccines, CNS and rare diseases, and doesn’t discuss device first-in-human studies.

Novotech vs bioaccess®

Dimension	Novotech	bioaccess®
Core focus	Full-service Asia-Pacific CRO, drug-led	First-in-human and early feasibility studies for medical devices
Geography	Asia-Pacific, including New Zealand	Latin America, since 2010
Device FIH track record	Not covered in the New Zealand article	Published case studies on bioaccessla.com
After the trial	See provider site	Multi-country sanitary registration and in-country holder service

Where each one fits

For a drug program that will expand across Asia-Pacific, Novotech’s New Zealand-plus-region model is coherent. For Novotech’s Australian positioning, see our Novotech Australia page.

If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Novotech, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.

New Zealand offers real country advantages:
– device trials need HDEC ethics approval but no Medsafe approval;
– one ethics review covers all sites;
– HDEC aims to decide within 15 days (expedited review) or 35 days (full review).

Those advantages belong to the country, not to Novotech. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.

Frequently asked questions

Are the 4–6 week and 30–50% figures official?

No. They are Novotech’s own claims. The official figures are HDEC’s 15- and 35-day review targets and Medsafe’s 32-working-day target for drug trial applications. Devices don’t need Medsafe approval.

Does a device trial in New Zealand need Medsafe approval?

No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).

Can Latin American device data support an FDA submission?

Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.

When is bioaccess® the better choice than Novotech?

When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts come from the Novotech public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.

If you typed Vera Research into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what Vera publishes (veraresearch.nz, What we do) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.

What Vera publishes

Vera Research focuses on vascular devices, therapies and endovascular procedures. It says it has “deep experience in first-in-human trials, preclinical requirements, and regulatory approvals”, and offers early-stage consulting, study design, regulatory approvals, patient recruitment and on-the-ground trial management. It describes itself as “combining global insights with expertise in New Zealand”. Its public site doesn’t list named studies, headcount or certifications.

Vera vs bioaccess®

Dimension	Vera	bioaccess®
Core focus	Vascular and endovascular first-in-human consulting and trial management	First-in-human and early feasibility studies for medical devices, across therapeutic areas
Geography	New Zealand	Latin America, since 2010
Device FIH track record	Stated focus; no named studies on its public site	Published case studies on bioaccessla.com
After the trial	See provider site	Multi-country sanitary registration and in-country holder service

Where each one fits

If you have a vascular or endovascular device and want a New Zealand team that specialises in that field, Vera is a natural shortlist entry.

If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Vera, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.

New Zealand offers real country advantages:
– device trials need HDEC ethics approval but no Medsafe approval;
– one ethics review covers all sites;
– HDEC aims to decide within 15 days (expedited review) or 35 days (full review).

Those advantages belong to the country, not to Vera. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.

Frequently asked questions

Is Vera Research a full-service CRO?

Its site describes consulting, study design, regulatory approvals, recruitment and on-the-ground trial management for vascular research. Ask Vera which functions it provides directly, such as monitoring, data management and safety.

Does a device trial in New Zealand need Medsafe approval?

No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).

Can Latin American device data support an FDA submission?

Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.

When is bioaccess® the better choice than Vera?

When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts come from the Vera public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.

If you typed Aotearoa Clinical Trials (ACTT) into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what ACTT publishes (aotearoatrials.nz/sponsors, ACTT Annual Report 2025) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.

What ACTT publishes

ACTT calls itself “New Zealand’s largest public-hospital-based clinical research site network”. It claims Phase I–IV capability “from early first-in-human studies through to post-marketing research”, centralised feasibility review, IAOCR Gold accreditation, and status as an IRD-approved Research Provider for New Zealand’s R&D Tax Incentive. Its 2025 Annual Report says it partners with “biopharmaceutical and medical device companies from around the world”. It also notes that after “a challenging 2024, trial activation numbers have rebounded”, and it reports a new hospital-based Phase I overnight facility at Middlemore. We found no named device first-in-human study on the public pages we reviewed.

ACTT vs bioaccess®

Dimension	ACTT	bioaccess®
Core focus	Public-hospital site network, Phase I–IV	First-in-human and early feasibility studies for medical devices
Geography	New Zealand (Counties Manukau, Northland and network hospitals)	Latin America, since 2010
Device FIH track record	Says it partners with device companies; no named device FIH found	Published case studies on bioaccessla.com
After the trial	See provider site	Multi-country sanitary registration and in-country holder service

Where each one fits

If you want New Zealand public-hospital investigators and a single network contract, and your enrollment target fits New Zealand’s population, ACTT fits well. Its approved-provider status also matters if you have a New Zealand entity claiming the R&D Tax Incentive.

If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including ACTT, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.

New Zealand offers real country advantages:
– device trials need HDEC ethics approval but no Medsafe approval;
– one ethics review covers all sites;
– HDEC aims to decide within 15 days (expedited review) or 35 days (full review).

Those advantages belong to the country, not to ACTT. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.

Frequently asked questions

Can ACTT help me claim New Zealand’s R&D Tax Incentive?

ACTT says it is an IRD-approved Research Provider. Eligibility depends on your own New Zealand tax position. Inland Revenue sets the rules.

Does a device trial in New Zealand need Medsafe approval?

No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).

Can Latin American device data support an FDA submission?

Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.

When is bioaccess® the better choice than ACTT?

When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts come from the ACTT public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.

If you typed Momentum Clinical Research into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what Momentum publishes (momentumclinicalresearch.co.nz (p3research.co.nz now redirects there)) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.

What Momentum publishes

Momentum calls itself “Australasia’s largest clinical trial network”. It reports 19 clinical research sites across Australia and New Zealand “streamlined under one centralised system”, more than two decades of Phase I–IV experience across most therapeutic areas, and 118 active studies. The former P3 Research website now redirects to Momentum. We found no named medical-device first-in-human study on its public pages.

Momentum vs bioaccess®

Dimension	Momentum	bioaccess®
Core focus	Phase I–IV site network, mainly drug studies	First-in-human and early feasibility studies for medical devices
Geography	Australia and New Zealand (19 sites)	Latin America, since 2010
Device FIH track record	None named on the public pages we reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Multi-country sanitary registration and in-country holder service

Where each one fits

If your drug trial needs many trans-Tasman sites under one contract and one system, Momentum is built for that.

If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including Momentum, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.

New Zealand offers real country advantages:
– device trials need HDEC ethics approval but no Medsafe approval;
– one ethics review covers all sites;
– HDEC aims to decide within 15 days (expedited review) or 35 days (full review).

Those advantages belong to the country, not to Momentum. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.

Frequently asked questions

Is Momentum the same as P3 Research?

The p3research.co.nz web address now redirects to Momentum Clinical Research’s New Zealand site. For corporate details, check Momentum directly.

Does a device trial in New Zealand need Medsafe approval?

No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).

Can Latin American device data support an FDA submission?

Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.

When is bioaccess® the better choice than Momentum?

When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts come from the Momentum public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.

If you typed NZCR Group (NZCR + Optimal Clinical Trials) into a search box, you’re probably building a shortlist for a trial in New Zealand. This article uses only what NZCR publishes (nzcr.co.nz, NZCR facilities and services, optimalclinicaltrials.com) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It’s a practitioner comparison, not a teardown.

What NZCR publishes

NZCR calls itself “New Zealand’s leading early-phase clinical research provider”. It says it has 35+ years of experience, has run 800+ trials with 17,000+ New Zealanders, and has 81 research beds. Its dosing units are in Auckland and Christchurch, with support sites in Hamilton and Wellington, and the units are Medsafe-certified under section 30 of the Medicines Act. Its sister company, Optimal Clinical Trials, focuses on late-phase work. Optimal describes the “NZCR Group” as “Australasia’s largest clinical trials group”. It claims “fast start-ups (4–6 weeks, no IND requirement)”, ISO 9001 certification, access to about 75% of New Zealand’s primary-care database, and a patient pool of 153,000+. It also says it is a government-approved R&D incentives provider and a “proven rescue site”. We found no named medical-device first-in-human study on the pages we reviewed.

NZCR vs bioaccess®

Dimension	NZCR	bioaccess®
Core focus	Drug Phase I units (NZCR) plus late-phase sites (Optimal)	First-in-human and early feasibility studies for medical devices
Geography	New Zealand (Auckland, Christchurch, Hamilton, Wellington)	Latin America, since 2010
Device FIH track record	None named on the public pages we reviewed	Published case studies on bioaccessla.com
After the trial	See provider site	Multi-country sanitary registration and in-country holder service

Where each one fits

If you are running a healthy-volunteer or patient Phase I drug study and want overnight beds in New Zealand, NZCR is a serious option. Optimal’s primary-care reach suits large late-phase recruitment.

If the job is a first-in-human or early feasibility study for a medical device, and especially one that needs more patients than one small country can supply, bioaccess® was built for exactly that. It has run device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO on your list, including NZCR, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan, and how the data was used in an FDA file.

New Zealand offers real country advantages:
– device trials need HDEC ethics approval but no Medsafe approval;
– one ethics review covers all sites;
– HDEC aims to decide within 15 days (expedited review) or 35 days (full review).

Those advantages belong to the country, not to NZCR. New Zealand also has about 5.36 million people, and commercial sponsors must provide ACC-equivalent injury compensation. We set out the country comparison in New Zealand vs Latin America for first-in-human device trials and bioaccess® vs New Zealand.

Frequently asked questions

Does NZCR run medical device first-in-human studies?

NZCR’s public pages describe drug early-phase units and services. We found no named device first-in-human study there. Ask NZCR directly for device examples.

Does a device trial in New Zealand need Medsafe approval?

No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified, and HDEC ethics approval is required (Medsafe guideline, §7).

Can Latin American device data support an FDA submission?

Yes. Foreign device data is eligible for FDA review under 21 CFR 812.28 when GCP, independent ethics review and informed consent are met, and FDA can validate the data. Eligibility isn’t clearance or approval.

When is bioaccess® the better choice than NZCR?

When the study is a device first-in-human or early feasibility study, needs a second country or more patients, or needs U.S.-adjacent time zones and a route to registration in Latin America.

Ready to compare a proposal? Request a first-in-human study proposal.

Competitor facts come from the NZCR public pages linked above, reviewed 28 October 2026 for bioaccess® competitive research. The claims are theirs. No sponsors, prices or contacts are invented.

New Zealand is one of the quickest places in the world to start a first-in-human device study. Medsafe doesn’t approve device trials, one national ethics committee covers every site, and no FDA IDE is needed to begin. What New Zealand can’t change is its size: about 5.36 million people. If your protocol needs more patients, more diversity or a backup country, Latin America is where bioaccess® has run device first-in-human studies since 2010.

Why sponsors choose New Zealand

These are the real reasons, and each one has an official source.

• No regulatory approval for device trials. Medsafe says there is “no provision under the current legislation (the Medicines Act 1981) to require approval of clinical trials of medical devices”. It asks to be told by email, and that notice “does not constitute an approval” (Medsafe Clinical Trials Guideline, §7; Medsafe device trials page). Investigational devices brought in for a trial don’t need WAND notification.
• One ethics review for all sites. A single Health and Disability Ethics Committee (HDEC) review covers every site. Each site still needs locality authorisation (Callaghan Innovation HealthTech Activator).
• Published ethics clocks. HDEC aims to decide expedited applications within 15 calendar days and full reviews within 35 (HDEC).
• No IDE to start. The government’s own guidance notes that New Zealand’s process “does not currently require U.S FDA Investigational Device Exemption (IDE) filing prior to the start of the study” (Callaghan).
• English and GCP. Trials are expected to follow ICH E6(R3), and Medsafe points device sponsors to ISO 14155.
• Tax incentives, with limits. New Zealand’s R&D Tax Incentive is a 15% credit for eligible R&D by NZ taxpayers, and overseas spend is capped (Inland Revenue). Australian companies can claim New Zealand trial costs under Australia’s R&D Tax Incentive, but only with an approved Overseas Finding (business.gov.au).

What to plan for in New Zealand

• Patient volume. Stats NZ estimates 5,357,300 residents (30 June 2026) (Stats NZ). For a rare anatomy or a narrow inclusion window, the pool of candidates is limited.
• Real-world ethics timing. HDEC’s Secretariat warns that full applications can take another 2–4 weeks to get onto an agenda, that it caps each meeting at 8–10 applications, and that decision letters can take up to 4 weeks after the meeting. For expedited review, plan on the full 15-day clock (HDEC update).
• Injury compensation is the sponsor’s job. New Zealand’s ACC scheme doesn’t cover trials run “principally for the benefit of the manufacturer” (Accident Compensation Act s32). Commercial sponsors must offer ACC-equivalent compensation, including earnings-related compensation, for the whole trial (NEAC Standard 17).
• Site governance. Health New Zealand sites run their own research-office review, which includes a Māori responsiveness assessment and scientific peer review (Callaghan).
• The rules are changing. A Ministry of Health briefing calls New Zealand’s lack of device pre-market approval an international outlier. The planned Medical Products Bill is expected to be introduced in 2027, with commencement expected around 2029–2030 (MoH briefing, June 2026; DHA, May 2026).

What the registry data shows

We pulled ClinicalTrials.gov on 28 October 2026. Of 216 closed interventional device studies with a New Zealand site, 11.1% were terminated or withdrawn, compared with 22.7% for the United States and 13.2% for Australia. Only 6 of the 216 named slow or low recruitment as the reason, and most of those ran in New Zealand only. Starting is rarely the problem in New Zealand; enrolling enough patients can be. (Method: CT.gov API v2, interventional, intervention type = device, ≥1 site in the country. Many ANZ studies register only on ANZCTR.)

New Zealand vs Latin America at a glance

	New Zealand	Latin America with bioaccess®
Device trial regulator	No Medsafe approval; email notification only	Varies by country. Some add a regulator review (e.g., Argentina’s ANMAT under Disposition 969/1997, up to 90 business days)
Ethics	One national HDEC review; 15 or 35 calendar-day targets	Site or national committees; timing set by each committee’s meeting schedule
Patient pool	5.36M nationally	Several countries’ catchments can run under one plan
Time zone vs U.S.	UTC+12 (+13 in NZ daylight time)	Same or near U.S. time zones
Injury cover	Sponsor provides ACC-equivalent compensation	Sponsor clinical-trial insurance per country rules
FDA use of data	Eligible under 21 CFR 812.28 if GCP, ethics and consent are met	Same standard (21 CFR 812.28)
After the trial	Device market currently has no pre-market approval	bioaccess® offers in-country registration and holder service (market access)

Which fits your study

• Choose New Zealand if you need a few implants fast, your investigators are already there, and your enrollment target fits a 5-million-person country.
• Add Latin America if you need more patients, a second country to protect timelines, U.S.-adjacent time zones for your clinical team, or a route from first-in-human data to market access in the region.
• Run both if speed of first implant and enrollment certainty both matter. Being eligible under 812.28 is not the same as clearance; FDA decides case by case.

New Zealand CRO and site comparisons

• NZCR Group (NZCR + Optimal Clinical Trials) vs bioaccess®
• Momentum Clinical Research vs bioaccess®
• Aotearoa Clinical Trials (ACTT) vs bioaccess®
• Vera Research vs bioaccess®
• Novotech New Zealand vs bioaccess®
• Precision for Medicine New Zealand vs bioaccess®

Frequently asked questions

Does New Zealand require Medsafe approval for a medical device clinical trial?

No. Under the Medicines Act 1981 there is no provision to require approval of device trials. Medsafe asks to be notified by email, and notification is not approval. HDEC ethics approval is still required.

How long does HDEC ethics approval take?

HDEC aims to decide expedited applications within 15 calendar days and full reviews within 35. The clock can pause once for up to 90 days. Its November 2024 update adds agenda and letter delays for full reviews.

Do I need an FDA IDE to run a first-in-human device study in New Zealand?

Not to start in New Zealand. If the data will support a U.S. submission, it must meet 21 CFR 812.28 (GCP, ethics review, informed consent, and FDA’s ability to validate the data).

Does ACC cover injuries in a sponsored device trial?

No, not for trials run principally for the manufacturer’s benefit. The sponsor must provide ACC-equivalent compensation, usually through no-fault clinical trial insurance accepted by HDEC.

Can a U.S. startup claim New Zealand’s 15% R&D Tax Incentive?

The incentive is for eligible R&D by entities taxed in New Zealand, and overseas spend is capped. Check eligibility with Inland Revenue before you count it in your budget.

Why would a sponsor add Latin America after New Zealand?

Mainly patient volume and backup capacity. Same- or near-U.S. time zones and a path to regional registration also help. bioaccess® has run device first-in-human and early feasibility studies in Latin America since 2010.

Request a first-in-human study proposal · bioaccess® vs New Zealand · bioaccess® vs Australia

Sources accessed 28 October 2026. No sponsor, prices or timelines are invented. Competitor and country claims are attributed to their publishers.

General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.

Signs you are behind

• The registered primary completion date has passed and the study still shows recruiting.
• Sites have been added mid-study.
• Screen-failure rates are higher than the protocol assumed.

For the underlying math, see catchment math for Australian recruitment.

A same-protocol second country

See adding a Latin American country to an Australia-only NCT, and our bioaccess® vs Australia comparison for the R&D tax incentive question.

Standards and U.S. data acceptance

The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia, the Caucasus or Latin America.

How Latin America compares

• Same FDA rule: 21 CFR 812.28.
• Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
• Time zone: 0–2 hours from U.S. Eastern.
• U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
• Trade-offs: Spanish or Portuguese documents and investigational import permits.

More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Vantage Clinical comparison

Frequently asked questions

Can I add a Latin American country to an Australian FIH?

Yes, a second country can run under the same protocol with its own ethics and regulatory approvals.

Will FDA accept the combined data?

Foreign data can support FDA submissions under 21 CFR 812.28, case by case.

Next step

Weighing Central Asia or the Caucasus against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerator podcast to talk through your FIH plan.