Figures as of 30 September 2026. General information, not legal or regulatory advice. bioaccess® is not affiliated with any Paraguayan authority. Rules change; confirm current terms with qualified advisers.
Paraguay is a proven first-in-human destination for cardiovascular devices — fast approvals under the Resolution 614 framework and a world-class investigator in Dr. Adrian Ebner (70+ first-in-human studies). The documented risk is light GCP oversight, which is why how you run Paraguay matters more than whether. bioaccess® runs Paraguay FIH under ISO 14155 with FIH-12™ operational discipline, producing FDA-bridgeable data: Supira Medical's pVAD program is the proof. Figures as of September 2026; general information, not regulatory advice.
| Metric | bioaccess® | Paraguay |
|---|---|---|
| Headline draw | Paraguay's speed, run to FDA-scrutiny GCP standards — with the Supira FIH program as proof | Fast approvals (3–4 months; as little as ~1 week with the right government contacts) — with the GCP-oversight question documented in industry reporting |
| Regulatory path | Full submission management: DINAVISA, ethics committee, informed consent, safety reporting | Resolution 614 (December 2016) framework via DINAVISA; approval timelines per local experts |
| GCP discipline | ISO 14155, FIH-12™ operations, monitoring, data management — an audit-ready file | Light GCP oversight is the documented industry concern; the sponsor carries the documentation risk |
| Investigator access | Named FIH investigators — Dr. Adrian Ebner (70+ first-in-human studies), Italian Hospital, Asunción | Access depends on who you know |
| FDA bridging | Data packaged for FDA consideration under 21 CFR 812.28; Supira: FIH Paraguay → Breakthrough Device Designation → U.S. EFS → FDA-approved pivotal trial | Speed without the bridge is a stranded dataset |
| Published proof | Supira Medical pVAD FIH (September 2022): 70+ patients treated in South America, zero bleeding or access-site complications | No published program to cite on this page |
| Cost | LATAM cost base, USD-denominated contracts — per-patient $15K–$35K versus $40K–$75K typical US/EU | DIY headline costs vary; the comparison that matters is cost per FDA-usable dataset |
| Ethics & safety oversight | Ethics committee management, informed consent development, safety reporting, tecnovigilancia | Variable by site and contact |
| Where arranging it yourself is genuinely stronger | One accountable CRO across 19 Latin American & Caribbean countries | A sponsor with its own audited Paraguayan operation and investigators doesn't need this page — or a CRO |
The Paraguay column quotes the public sources listed below. The bioaccess® column comes from bioaccessla.com and reflects our FIH-12™ operating model.
Start with what Paraguay is, honestly. It is fast: local experts put study approval at three to four months, and as little as one week with the right government contacts, under the Resolution 614 framework the Ministry of Health put in place in December 2016. DINAVISA has kept modernizing — IMDRF affiliate member since September 2024, a simplified 15-business-day IVD procedure, and a December 2024 good-evaluation-practices guide that leans on recognized international regulators. And it is a genuine cardiovascular FIH hub: Dr. Adrian Ebner, an internationally renowned cardiovascular surgeon, has been involved in 70+ first-in-human studies for products that went on to CE marks, FDA approvals, or acquisition by large device companies. None of that is marketing. It is the public record.
The GCP question is also the public record, and we will not hide it. Industry reporting has documented concerns about corruption in Paraguay's clinical-trial approval process and light oversight of good clinical practices — the same reporting notes that medtech companies wanting studies above reproach have limited interest in running trials there. That sentence is the whole reason this page exists: Paraguay's speed is only an advantage if the dataset it produces can survive a regulator's file review. A fast approval that leaves you with an unauditable file is not a shortcut; it is a stranded program.
bioaccess®'s answer is not to sell Paraguay's speed — it is to run Paraguay studies that survive FDA scrutiny. Supira Medical's first-in-human program for its percutaneous ventricular assist device started at the Italian Hospital in Asunción in September 2022 under Dr. Ebner: 70+ patients treated in South America with zero bleeding or access-site complications. That dataset supported FDA Breakthrough Device Designation, a U.S. early feasibility study initiated in November 2024, and FDA approval of the SUPPORT II pivotal trial in April 2026. That trajectory — Asunción FIH to FDA-approved U.S. pivotal in under four years — is what 'above reproach' looks like in practice: ISO 14155 conduct, FIH-12™ operational discipline, ethics committee management, monitoring, data management, and safety reporting, run by one accountable CRO.
If you already run an audited, GCP-compliant operation in Paraguay with your own investigators, this page has done its job and you don't need us for the country. For everyone else weighing Paraguay: the question was never whether Paraguay is fast. It is. The question is whether your dataset will be worth what you paid for it. Figures on this page are as of September 2026 and are general information, not legal or regulatory advice.
According to local experts cited in industry reporting, a study approved in Paraguay typically takes three to four months — and can be shortened to as little as one week with the right government contacts. Approvals run under the Resolution 614 framework (December 2016) via DINAVISA, which has continued modernizing: IMDRF affiliate membership since September 2024 and a December 2024 good-evaluation-practices guide with reliance on recognized international regulators.
Industry reporting has documented concerns about corruption in Paraguay's clinical-trial approval process and light oversight of good clinical practices — noting that medtech companies wanting studies above reproach have limited interest in the country. The concern is about oversight and documentation discipline, not about the country's investigators or patients. It is mitigated the way any GCP risk is mitigated: ISO 14155 conduct, independent monitoring, audit-ready files, and a CRO accountable for the dataset. Supira Medical's Paraguay FIH program — 70+ patients, zero bleeding or access-site complications, onward to FDA Breakthrough designation and an FDA-approved U.S. pivotal trial — is the working proof.
Dr. Adrian Ebner is an internationally renowned cardiovascular surgeon, trained in France, described in industry reporting as the pioneer of medtech clinical research in Paraguay. He has been involved in 70+ first-in-human studies for products that went on to receive CE marks, FDA approvals, or acquisition by large medical device companies, and he was the principal investigator for Supira Medical's FIH heart-pump trial at the Italian Hospital in Asunción.
Foreign clinical data from Paraguay can support a U.S. submission when it meets the applicable requirements (21 CFR 812.28 for devices, conducted under GCP) — acceptance is determined by the FDA case-by-case, and eligibility is not clearance or approval. The Supira Medical trajectory is the concrete example: FIH in Paraguay (2022) → FDA Breakthrough Device Designation → U.S. early feasibility study (November 2024) → FDA-approved SUPPORT II pivotal trial (April 2026).
…you already run an audited, GCP-compliant operation in Paraguay with your own investigators and ethics relationships — then you don't need a CRO for the country, and this page says so plainly. If instead you want Paraguay's speed with a dataset built to survive FDA scrutiny — a named FIH investigator, ISO 14155 conduct, and one accountable CRO across Paraguay and the rest of Latin America — that is the program bioaccess® runs.
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