You picked New Zealand. It starts fast: there is no provision under the Medicines Act 1981 to require approval of medical device trials (Medsafe asks only to be notified), and one HDEC ethics review covers all sites, with 15-day expedited and 35-day full-review targets. Its constraint is patient volume (5,357,300 people, Stats NZ, June 2026). If you need more patients or a second country, bioaccess® runs first-in-human across Latin America from Miami.
| Metric | bioaccess® | New Zealand |
|---|---|---|
| Role on this page | Country 2 — U.S. regulatory anchoring + Latin American execution from Miami | Country 1 — the destination you already picked |
| Device trial regulator | Varies by country. For device studies, Argentina's ANMAT reviews under Disposition 969/1997, which allows up to 90 business days (ANMAT Disp. 969/1997, https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-969-1997-42205/texto) from filing for a decision; objections pause the clock | No regulatory approval: the Medicines Act 1981 has no provision to require approval of device trials. Medsafe asks for an email notification, which is not an approval |
| Ethics | Site or national committees by country. First-patient timing varies by study (we confirm it per protocol). Ethics 4–8 weeks median | One national HDEC review covers all sites (plus locality authorisation). Targets: 15 calendar days expedited, 35 full review; HDEC's Nov 2024 update adds agenda and letter delays |
| Patient pool | Several Latin American countries' catchments under one plan | 5,357,300 residents (Stats NZ, 30 June 2026) |
| Injury compensation | Sponsor clinical-trial insurance per each country's rules | ACC does not cover trials run principally for the manufacturer's benefit; sponsors must provide ACC-equivalent compensation (NEAC Standard 17) |
| Drug trials | Country-specific regulator and ethics review | Section 30 approval on SCOTT's recommendation; Medsafe's guideline targets an outcome within 32 working days of receiving the application |
| FDA acceptance & data applicability | Data conducted under GCP (ISO 14155 for devices; ICH E6 for drugs) is eligible for FDA submission and review under 21 CFR 812.28 or 312.120. Eligibility is not clearance or approval | Same standard. No FDA IDE is needed to start a device study in New Zealand |
| Distance & time zone from the U.S. | Same or adjacent U.S. time zones; ~3–8 hour flights (already published on the Australia compare) | UTC+12 (UTC+13 in New Zealand daylight time). We will not invent a Miami–New Zealand flight-hour figure |
| Where it is genuinely stronger | More patients across countries, U.S.-adjacent time zones, regional registration and holder service after the trial | Ethics-only device pathway, one national ethics review, English-language operations. If your New Zealand file is moving, stay |
New Zealand rows cite Medsafe, HDEC, Stats NZ, NEAC and Inland Revenue (sources below). CRO marketing figures for New Zealand (for example "4–6 weeks" or "30–50% cheaper") are those firms' own claims and are not used as facts here. Under New Zealand's planned Medical Products Bill (introduction expected 2027), device rules may change.
You picked New Zealand. That is country 1, and this page does not talk you out of it. New Zealand has a genuinely light device pathway: Medsafe does not approve device trials, and one HDEC ethics review covers every site. We will not move Australia's rebate onto New Zealand — the 43.5% refundable offset on /compare/australia is an Australia fact. New Zealand's own R&D Tax Incentive is a 15% credit for eligible R&D by New Zealand taxpayers.
What New Zealand cannot change is its size. Stats NZ estimates 5,357,300 residents. For a narrow anatomy or inclusion window, that caps how many candidates you will see. ClinicalTrials.gov shows few New Zealand device studies stopped for recruitment, but the ones that did were mostly single-country New Zealand studies.
bioaccess® is the First-in-Human CRO. Miami headquarters. U.S. regulatory anchoring plus Latin American execution. Adding Latin America as country 2 gives you more patients, same- or near-U.S. time zones, and a route to registration and an in-country holder after the trial.
Foreign device data is eligible for FDA submission and review under 21 CFR 812.28 when GCP / ISO 14155, ethics, and consent are met — whether it comes from New Zealand or Latin America. Eligibility is not clearance or approval. If New Zealand is moving, stay. If you need country 2, Latin America is the answer.
No. There is no provision under the Medicines Act 1981 to require approval of clinical trials of medical devices. Medsafe asks to be notified by email, and notification is not an approval. HDEC ethics approval is still required before the trial starts.
HDEC aims to decide expedited applications within 15 calendar days and full reviews within 35, and the clock can be suspended once for up to 90 days. Its November 2024 update warns full applications may wait an extra 2–4 weeks for an agenda and that decision letters can take up to 4 weeks after the meeting.
For new medicines that need section 30 approval, Medsafe's current guideline targets an outcome within 32 working days of receiving the application, once the invoice is paid, on the recommendation of the Health Research Council's SCOTT. Device trials do not need this approval.
Not when the trial is run principally for the benefit of the manufacturer or distributor. Sponsors must make ACC-equivalent compensation available for the whole trial (NEAC Standard 17), usually through no-fault clinical trial insurance accepted by HDEC.
No. The 43.5% refundable offset is an Australia fact on /compare/australia, and we will not move Australia's rebate onto New Zealand. New Zealand's R&D Tax Incentive is a 15% tax credit for eligible R&D by New Zealand taxpayers, with overseas spend capped.
Foreign clinical data from either region can support a U.S. submission when it meets the applicable requirements (21 CFR 812.28 for devices, 21 CFR 312.120 for drugs, conducted under GCP). Acceptance is determined by the FDA case-by-case. Eligibility is not clearance or approval.
New Zealand is the only geography your protocol and regulatory plan will accept, your enrollment target fits a 5.36-million-person country, and that file is moving. Stay. bioaccess® is the better fit when you need more patients or a second country on a startup runway.
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