Does Panama require functional large-animal studies for a medical device FIH?

Sponsors planning a Panama first-in-human (FIH) medical-device study keep asking the same yes/no question: does MINSA require a functional large-animal study before ethics or Ministry review will move?

I am Julio Martinez-Clark, CEO of bioaccess®. Short answer: no. Functional large-animal studies are not a hard, across-the-board MINSA requirement for a Panama FIH device study. The longer answer is what you need for the dossier.

This note sits next to our live Decreto 21 of 2026 explainer and the Panama FIH device guide. It is operator guidance, not legal advice and not a quote.

One-sentence answer

Panama’s current clinical-research rulebook sets process and documentation. It does not publish a required animal n, species, duration, or GLP (Good Laboratory Practice) quota for investigational medical devices.

What the rulebook actually says

Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) implements Titles III and IV of Ley 84 of 14 May 2019. For sponsors, the decree turns on three operational gates:

• Registration on RESEGIS (MINSA’s national research-registration platform) before execution begins
• Ethics review by a Type II committee accredited by CNBI (Comité Nacional de Bioética de la Investigación)
• Parallel MINSA and ethics review for higher-risk protocols

The decree also defines the documentation package — protocol, investigator’s brochure (IB), informed consent, insurance, and related files, in Spanish. It does not set a preclinical animal checklist.

What MINSA and the CNBI-accredited committee actually review

Reviewers look for a coherent risk-benefit narrative, not a species count. In practice that means:

• ISO 10993 biocompatibility evidence that is scientifically valid for the contact and duration you claim (GLP wrapping helps when you have it; it is not the only acceptable form)
• Mechanical and functional bench data that match the intended use
• Sterilization and packaging evidence for the investigational configuration
• An ISO 14971 risk file that ties residual risks to the first-in-human cohort
• An IB that documents the safety information you actually have

When the device class, contact duration, or mechanism warrants animal data, that data goes in the narrative. Animal work is a conditional element of the risk story. It is not a statute that says “run a porcine efficacy study or stop.”

How this differs from a class-specific scientific frame

Some device classes commonly use large-animal models with functional outcomes, histology, and imaging correlation — for example certain injectable or implant programs where the science community expects that evidence. Treat those models as a scientific frame for that class, not as a Panama statute. Confusing the two is how teams overbuild the wrong study or underbuild the IB.

What did not get stricter after Decreto 21

Decreto 21 of 2026 tightened process: ethics accreditation, RESEGIS registration, defined review clocks, and parallel review for high-risk protocols. It did not invent a new large-animal efficacy mandate.

Public Panama FIH experience on the site includes ReGelTec’s early hydrogel program, which cleared its FIH file with a GLP-where-applicable ISO 10993 biocompatibility battery, genotoxicity, and chemical characterization — without a large-animal efficacy study. Panama’s posture on non-GLP R&D-grade preclinical evidence backed by an ISO 14971 file has not shifted into a checklist since that work.

Operator checklist before you ask for a Panama dictamen

1. Write one page that states what preclinical evidence you have and what residual risk it leaves for first-in-human use.
2. Map each residual risk to a control in the protocol (cohort size, stopping rules, imaging, monitoring).
3. Confirm the IB and ISO 14971 file tell the same story in Spanish for the CNBI-accredited Type II committee.
4. Register the study in RESEGIS before execution; do not treat ethics approval as a substitute for registration.
5. If you already have an animal study (or a deliberate gap), ask whether that study closes a risk the IB claims — not whether Panama “requires animals.”

Talk with bioaccess® when you need the Panama FIH dossier framed for CNBI and MINSA without inventing a statute that is not in Decreto 21.