Panama does not publish a required animal n, a required species list, or a 21 CFR Part 58 GLP stamp as a hard first-in-human gate. MINSA and the ethics committees look for a coherent risk-benefit case: enough bench, biocompatibility, and (when the device needs it) animal data to justify a small, monitored medical-device study, written into an ISO 14971 file and an investigator’s brochure.
That is the operator answer bioaccess® already gives when a sponsor asks “how much animal data for a Panama FIH?” The longer GLP and FIH guides already say it. They bury it. This page is the dedicated send.
What Panama actually reviews
For investigational device studies — especially early feasibility and first-in-human — Panama uses an ethics-committee-driven pathway. The Comité Nacional de Bioética de Investigación (CNBI) and the institutional ethics committee are the primary decision-makers. There is no separate national device-authority checklist of the kind you get from INVIMA or ANVISA.
CNBI review, as already published on the Panama FIH guide, includes scientific merit, risk-benefit and consent, investigator and site fit, patient-protection measures — and preclinical-data sufficiency evaluated as a coherent safety narrative, not a GLP checklist.
The early-feasibility guide is explicit: Brazil, Panama, and El Salvador accept R&D-grade (non-GLP) preclinical data for early feasibility device studies. In Panama that file is accepted when it is supported by an ISO 14971 risk-management file and an investigator’s brochure that records the safety information you actually have. Ethics committees want a plan for which studies you will later repeat under GLP if you are building an FDA file. They are not asking whether every test already carries a Part 58 stamp.
ISO 13485 certification is not required for an investigational early-feasibility device in Panama. Fitness-for-use documentation is enough: ISO 14971, lot traceability, functional verification, basic safety, and the brochure.
Decreto 21 of 2026 did not add an animal quota
The current clinical-research rulebook is Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C). It implements Titles III and IV of Ley 84 of 14 May 2019. The public Panama hub already names what that decree switched on: accredited Type II committees for clinical trials, RESEGIS registration, and parallel MINSA + ethics review for high-risk protocols.
Sponsors still file a Spanish package: protocol, investigator’s brochure, informed consent, and insurance. MINSA oversees investigations through the Dirección Nacional de Farmacia y Drogas. Ethics review runs through institutional bioethics committees registered with CNBI.
None of that published rulebook sets a required animal n, species, or duration. Do not read Decreto 21 as a hidden GLP animal mandate.
A typical degenerative-disc frame — not a mandate
The public first-in-human testing guide lists a typical preclinical frame that includes small-animal (rodent) proof-of-concept and large-animal models (porcine or ovine spine models) with functional outcomes, histology, and imaging correlation. Treat that as a frame for a degenerative-disc or injectable-hydrogel program, not as a Panama statute and not as a required n for your device.
If your device is not a spine injectable, do not copy that frame by habit. The ethics question stays the same: is this device safe enough for a controlled feasibility study in a small cohort with consent and monitoring?
Public precedent already on the site
The same first-in-human guide publishes the ReGelTec HYDRAFIL package that INVIMA and the independent ethics committee accepted for a first-in-human file in this device space: a 12-study GLP-where-applicable biocompatibility file compiled into a Biocompatibility Summary Report (ISO 10993 series, genotoxicity, chemical characterization and risk assessment). Latin American authorities, the page says, do not prescribe a specific list of preclinical tests. The burden is on the sponsor to show the device is safe for first-in-human use.
That published “how much” example is a GLP biocompatibility battery. It is not a mandated large-animal efficacy study for every Panama FIH. Panama’s own FIH FAQ still says R&D-grade (non-GLP) data is accepted with an ISO 14971 file and an investigator’s brochure.
The public ReGelTec case study already on bioaccessla.com records the out-of-U.S. first-in-human program across Colombia and Panama (75 patients), later used to support CE Mark and an FDA IDE. That is clinical-execution history, not a preclinical checklist.
The Panama FIH guide also records a different public case: the Axoft brain-computer interface first-in-human implantation in Panama, a novel device with no predicate, no prior human data, and R&D-grade preclinical testing. The ethics-committee pathway evaluated the risk-benefit narrative — investigator, monitoring, patient selection — rather than demanding a GLP certification that did not yet exist for that device category.
What to put in the investigator’s brochure
From the early-feasibility guide, ethics committees in the recommended jurisdictions typically look for:
- ISO 10993 biocompatibility that is scientifically valid — not necessarily GLP-wrapped
- Mechanical and functional bench data
- Sterilization verification (batch-level / verified sterility is accepted for early feasibility; include packaging-integrity and sterile-barrier evidence)
- An ISO 14971 risk file
- An investigator’s brochure that documents all available safety information
- A written plan for which studies you will later repeat under GLP if the file is going to FDA
For implants, the same guide also names endotoxin testing (LAL or rFC; USP <85> / ISO 11737-1). Hospital infection-control review is often the real sterility gate, not a national animal-study rule.
This page does not prescribe a required n, species, or duration for a named device. Device class, contact duration, and the specific ethics committee still decide.
If you need the Panama data for FDA later
FDA acceptance of a Latin America device investigation is a separate question from the Panama gate. Under 21 CFR § 812.28, FDA may accept foreign clinical data for an IDE, 510(k), De Novo, PMA, or HDE when the study was conducted under GCP, reviewed by an independent ethics committee, and used a device identical — or adequately compared — to the U.S. article. ISO 14155 is the device GCP bridge FDA has publicly recognized. A Panama ethics letter is not an FDA clearance prediction.
Build the investigator’s brochure and the trial master file as if an inspector will ask for them. That is how you keep the Panama FIH usable later. It is not how Panama decides whether you may start.
Related bioaccess® pages
- Why Panama is used for first-in-human device studies
- Which LATAM countries accept R&D-grade preclinical data, non-GMP devices, and verified sterility
- Will FDA accept a Latin America FIH study, and what does the typical preclinical frame look like
- Decreto 21 of 2026 — what sponsors need to know
- Short answer: does FDA accept LATAM clinical data?
- First-in-human study basics
If you are planning a Panama first-in-human device study, send bioaccess® the investigator’s brochure and the risk file. We will tell you whether the narrative is complete enough for CNBI and the institutional committee, or where the gaps are, without inventing an animal quota the statute does not write.