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; bioaccess® publishes a 4–8 week median |
| 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.