A U.S. medtech founder finishes a successful first-in-human study, looks at the map, and plans to register the device in five countries — now. Then the first document on every checklist stops the plan cold.
October 6, 2026
7
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
In short
Latin American device registrations require a certificate of free sale (CFS) from the competent authority of the country of origin. The FDA's Certificate to Foreign Government is issued only for devices legally marketed in the United States — a device in first-in-human testing cannot get one. The realistic sequence is: Latin America FIH, then reference-market clearance (CE mark or FDA authorization), then registrations abroad. Two more gates founders underestimate: ISO 13485 certification of the legal manufacturer and a validated sterilization process at SAL 10⁻⁶.
Here is the most common sequencing mistake in Latin American commercial planning. A U.S. medtech founder finishes a successful first-in-human study, looks at the map, and plans to register the device in Colombia, Brazil, Mexico, Chile, and Panama — now. The registration dossiers are downloaded. And then the first document on every checklist stops the plan cold: the certificate of free sale. The device isn't cleared anywhere yet, and there is no way to produce one.
This is the certificate-of-free-sale trap. Understanding it will save you a year of misplanned fundraising and commercial timelines.
What the document is, and why regulators demand it
A certificate of free sale (CFS) is a statement by a health authority that your device is lawfully marketed in its country of origin. Latin American regulators require one because they are, in effect, free-riding on a reference regulator's review: before they will authorize your device for their market, they want proof that a trusted authority — the U.S. Food and Drug Administration (FDA), a European competent authority, Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Australia's Therapeutic Goods Administration (TGA) — has already evaluated it and allowed it to be sold.
This is not a formality. It is the load-bearing document of the dossier. Chile requires it for the registro sanitario (sanitary registration), whether filed voluntarily under the Decree 25 transition or mandatorily once the deadlines hit. Colombia's INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), Brazil's ANVISA (Agência Nacional de Vigilância Sanitária), Mexico's COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios), and Panama under its Ley 419 of 2024 framework all require the equivalent. The names of the forms differ; the logic is identical.
Why a pre-clearance U.S. startup cannot produce one
The U.S. document that functions as a certificate of free sale is the FDA's Certificate to Foreign Government (CFG), issued under the agency's export certification program. The FDA issues a CFG only for devices that are legally marketed in the United States — meaning 510(k)-cleared, Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) approved, De Novo-granted, or 510(k)-exempt and properly listed. A device still in first-in-human testing, or operating under an Investigational Device Exemption (IDE), is not legally marketed. The FDA will not issue a CFG for it. There is no CFG equivalent for investigational devices.
Founders invariably reach for workarounds. None of them substitute:
- State health-department or chamber-of-commerce "certificates of free sale." These attest to a company's good standing or export activity, not to a health authority's marketing authorization. Regulators that require a CFS from the competent authority will reject them.
- Notarized manufacturer self-declarations. A company asserting about itself what a regulator is supposed to assert is not evidence.
- The FDA's Certificate of Exportability. This one is actively harmful to your case: it is issued precisely for devices not approved in the United States, under the export provisions of the Federal Food, Drug, and Cosmetic Act. Presenting it is, if anything, an admission that the product lacks domestic authorization.
The realistic route: Europe first
For a U.S. startup, the practical path to a valid CFS runs through Europe. A CE mark (Conformité Européenne) under the EU Medical Device Regulation (MDR), granted by a European notified body, comes with a certificate of free sale from the competent authority of the European country — and that is what reference-country provisions in Latin America accept. This is why the proven sequence for novel devices looks like this: Latin America first-in-human study, then CE mark, then FDA IDE submission. Registration abroad comes after reference-market clearance, not before. The ReGelTec HYDRAFIL program — a first-in-human implantable hydrogel study run in Colombia — followed this pattern: Latin American FIH first, then the FDA IDE pathway.
Two more gates founders underestimate
The CFS is the headline blocker, but two more dossier elements routinely surprise first-in-human-stage companies:
ISO 13485 certification. Latin American registrations expect a quality management system (QMS) certified to ISO 13485 (the International Organization for Standardization's medical-device quality standard) by the legal manufacturer. A first-in-human-stage company typically has a QMS in build-out, not a certified one. Certification is achievable in months, not years — but it must be planned, not assumed.
Validated sterilization. A commercial registration expects a validated sterilization process — for example, radiation per ISO 11137, ethylene oxide per ISO 11135, or moist heat per ISO 17665, all targeting a sterility assurance level (SAL) of 10⁻⁶ — rather than the lot-by-lot sterility verification that ethics committees accept for early feasibility studies. If your sterilization validation isn't done, the registration clock hasn't started.
What this means for your planning
Once you see the trap, the timeline corrects itself:
- Fundraising: do not model "FIH, then six months to registered in five countries." Model FIH, then reference-market clearance (CE mark or FDA authorization), then registrations. The gap between FIH completion and first registration is measured in the clearance timeline, not the dossier-preparation timeline.
- ISO 13485: start certification during the FIH, not after it. It is the one gate fully in your control, and it takes months you will not want to spend later.
- Notified body engagement: if Europe is your reference-market route, engage the notified body early — MDR review queues are the long pole for many startups, and the CE certificate is what unlocks every CFS-dependent filing downstream.
- Windows like Chile's: Chile's voluntary early-registration mechanism (available once ISP — Instituto de Salud Pública, Chile's Public Health Institute — issues its technical instructive, due by March 2027, ahead of the March 2028 implantable tranche) is genuinely valuable — but only usable if your clearance lands inside the window. A voluntary path you cannot file into is not a plan; sequence the clearance first, then check the window. See our Chile registration window analysis for the full mechanics.
Registration checklist: file only when all of these are true
Before filing any Latin American device registration, confirm you hold:
- A certificate of free sale from the competent authority of a reference country — FDA Certificate to Foreign Government, or CE mark plus the European competent authority's CFS.
- ISO 13485 certification of the legal manufacturer (not a QMS in progress).
- A validated sterilization process at SAL 10⁻⁶, with the validation report in hand.
- Spanish labeling and instructions for use, drafted to the target country's requirements.
- A local importer or distributor of record authorized to hold the registration — in most countries, a foreign manufacturer cannot file directly.
If any of the first three is missing, you are not six weeks from filing. You are one clearance, one certification, or one validation away — and each of those is a project, not a document.
Frequently asked questions
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