A new framework is a promise — not proof. Proof arrived in August 2026, when Panama's Ministry of Health authorized a first-in-human orthopedic implant study under the new decree.
October 6, 2026
6
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
In short
In August 2026, Panama's Ministry of Health (MINSA) authorized a first-in-human study of Nanochon's Chondrograft — a 3D-printed implant for focal knee-cartilage defects — at The Panama Clinic; the first patient was treated September 2, 2026 (ClinicalTrials.gov NCT07542184). It is the first verified orthopedic-implant FIH under Executive Decree 21 (April 2026). The case proves the machinery works end to end; it does not predict every committee decision, and the same clinic's earlier Axoft FIH ran under the prior regime — site experience, not Decree 21 precedent.
In April 2026, Panama rewrote the rules for clinical research. A new framework, however well drafted, is a promise — not proof. Proof arrives when a real sponsor files a real protocol, a real ethics committee reviews it, the Ministry of Health authorizes it, and a real patient gets treated.
That proof now exists for orthopedic implants. In August 2026, Panama's Ministry of Health (Ministerio de Salud, MINSA) authorized a first-in-human (FIH) study of Nanochon's Chondrograft — a 3D-printed implant for focal articular cartilage defects of the knee — at The Panama Clinic in Panama City. The first patient was treated on September 2, 2026. It is the first verified orthopedic-implant FIH authorized under Panama's new framework. Here is what the case demonstrates — and what it does not.
The framework, in brief
Panama's clinical-research rules rest on Law 84 of 2019, implemented by Executive Decree 21 (published April 23, 2026). For a device trial, the pathway runs through an ethics committee accredited by the National Bioethics Research Commission (Comité Nacional de Bioética de la Investigación, CNBI) at the Type II level, on statutory clocks — 20 business days for ordinary review. A technical review by MINSA runs alongside the ethics review. Registration in RESEGIS (Panama's national research registry) is a required step, clinical-trial insurance sits in the submission package, and the investigational device needs its own import permit.
On paper, that is one of the clearest FIH pathways in Latin America. Until August, it was also a lightly tested one — the decree was roughly four months old, and no orthopedic-implant FIH had been publicly authorized under it.
The case
Nanochon, Inc., a Baltimore medical-device company, is developing Chondrograft, a 3D-printed implant for focal cartilage lesions of the knee. The device holds Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) — the agency's program for devices offering significant advantages over existing options.
The study is a first-in-human, prospective early feasibility study at The Panama Clinic, led by principal investigator Dr. Juan Osorio with Dr. Emilio Tufiño of the clinic's regenerative sports medicine practice. It enrolls adults ages 22 to 60 with 1–2 femoral condyle or trochlear lesions who have failed conservative treatment.
The documented sequence:
- August 14, 2026 — MINSA regulatory authorization announced (PR Newswire). This date matters: it falls after Executive Decree 21 took effect, so the authorization ran through the new framework.
- September 2, 2026 — first patient treated (Business Wire), roughly three weeks after authorization.
- Now — recruiting, listed on ClinicalTrials.gov as NCT07542184.
Note the three stages, because sponsors conflate them constantly: regulatory authorization, first patient treated, and recruiting status are separate milestones with separate dates. A press release about one is not evidence of the others.
What this proves
It proves the machinery works end to end for an orthopedic implant under the new decree: a Type II-accredited committee reviewed the protocol, MINSA completed its technical review and issued the authorization, the import and insurance gates were cleared, and a patient was treated within weeks of authorization — not months. For founders evaluating Panama, the pathway mechanics are no longer theoretical. The statutory clocks, the parallel MINSA track, the RESEGIS registration, the insurance requirement — all of it functioned on a real file.
What one case does not prove
Honesty requires the other half. One knee-cartilage case does not predict every committee decision. A focal cartilage implant and a permanent spinal implant do not travel the identical track — higher-risk implantables route through the decree's high-risk intervention pathway, where committee discretion on the safety case is broader. And a single authorization tells you nothing about how a committee handles reviewer questions, protocol amendments, or adverse events mid-study. The framework is demonstrated; it is not yet seasoned.
One more distinction worth making, because the same clinic's name will come up: The Panama Clinic previously hosted Axoft's FINESSE first-in-human study of an implantable brain-computer interface — four patients treated in March and April 2025, now completed. That case proves the site's first-in-human experience. It does not prove the Decree 21 pathway, because it ran under the prior regime (Executive Decree 1110/2012). Same clinic, different law. Do not conflate the two.
The practical takeaway for founders
If you are budgeting a Panama FIH for an orthopedic device, budget the gates this case confirms: a CNBI-accredited Type II ethics committee on a 20-business-day clock, MINSA technical review running alongside (not after) the ethics review, RESEGIS registration, clinical-trial insurance placed with the submission — not after approval — and an import permit for the investigational device with a designated importer of record. None of those steps is new on paper. What is new is that a sponsor has now walked through all of them, under the new decree, with an orthopedic implant, on a documented timeline.
Panama's framework made a promise in April. In August and September, it kept it once. Sponsors should plan like it will keep it again — and verify like it might not.
For the legal basis behind Panama's preclinical standard, see our companion analysis: Does Panama Require Efficacy Data or a Large-Animal Study Before a First-in-Human Device Trial?
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