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. and Europe, 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.