After First Patients: How to Sequence FDA/IDE Data and LATAM Registration

Most founders treat Latin America as a trial geography until first patients are in, then treat it as a launch geography only after FDA has spoken. The post-FIH question is not “FDA first, then LATAM.” It is: what do you do with the same evidence package while the clock is still cheap?

You already have ethics approvals, an investigational import path, and a first cohort. Two clocks now compete for the same documents: FDA use of that data (IDE, 510(k), De Novo, or PMA) and sanitary registration at ANVISA, INVIMA, COFEPRIS, and ANMAT. Mixing those clocks is how teams lose a year.

The split that matters after first patients

Clinical-trial authorization and sanitary registration are not sequential stamps of the same permit. They are different legal objects, usually held by different local entities, with different import codes and different labeling.

• Trial authorization lets you treat patients under a protocol. The device arrives as an investigational product. The local face is often an importer of record (IOR) plus a site or CRO, not your future commercial holder.
• Sanitary registration lets you sell. The device arrives as a commercial product. The local face is an authorized representative / registration holder. The label, IFU, and QMS evidence must match the marketed configuration—not the “we’ll lock it after the last implant” version sitting in the design-history file.

Converting a trial import into a commercial shipment without a new holder, a new dossier, and a locked configuration is a new problem, not a paperwork update.

What FDA actually accepts from the FIH you just ran

OUS FIH data can support an IDE or a device marketing submission. That is not folklore. In February 2018 FDA issued a final rule on acceptance of data from clinical investigations of medical devices. FDA’s own summary is here: Acceptance of Data from Clinical Investigations for Medical Devices.

The operative text lives in 21 CFR 812.28 (Subpart B). In short:

1. FDA will accept information from a well-designed, well-conducted investigation conducted outside the United States to support an IDE or a device marketing application or submission if the investigation was conducted in accordance with good clinical practice (GCP) as defined in § 812.28(a)(1).
2. GCP, as defined there, includes independent ethics committee (IEC) review and approval (or a favorable opinion) before initiation, continuing IEC review, and documented informed consent—except in the narrow life-threatening situations the regulation itself describes.
3. The sponsor or applicant must submit the supporting information in § 812.28(b) (or a cross-reference to where it lives in the file), including a description of the actions taken to ensure the research conformed to GCP.

Do not “clean the data later for FDA” while you send a different CSR to Latin America. One evidence room. If the FIH lacked IEC review, consent, monitoring, and traceable source, you have a feasibility anecdote, not a bridge.

QMSR is the other quiet bottleneck. FDA’s quality-system expectations sit on ISO 13485 architecture. A LATAM holder who cannot produce design controls, CAPA, supplier control, and a PMS plan will stall a registro even when the clinical tables look fine.

What you are actually waiting on after FIH

After first patients, the calendar is usually waiting on you—not “the regulator.”

1. Configuration lock. Registration is for a defined product, models, accessories, software version, and intended use. If you are still iterating the delivery system after patient 6, you are not registration-ready.
2. A CSR or a disciplined interim. High-risk dossiers want clinical evidence, not a slide. File on a pre-specified locked interim or wait for last-patient-last-visit. That choice drives the country clocks below.
3. The commercial holder, not the trial IOR. Brazil, Mexico, Colombia, and Argentina all require a local legal person to hold or promote the sanitary authorization. Appointing that holder after you “finish the study” is how you add a quarter you will never get back.
4. Language and labeling. Portuguese IFU for Brazil. Spanish labeling for Mexico (NOM-137 is the usual label conversation), Colombia, and Argentina. English source files that are still in draft are not a translation problem; they are a lock problem.
5. Import identity. Investigational import permissions expire with the trial. Commercial import needs a registration number, a holder, and a tariff/sanitary identity that matches the registered product.

Four country clocks—registration, not trial

These are market-access clocks. They are not the trial-authorization clocks you already ran.

ANVISA (Brazil) — notification vs registro

ANVISA’s English medical-device page states that equipment is premarket-authorized under two regimes: notification for risk Classes I and II, and marketing authorization (registro) for Classes III and IV, under the classification rules in RDC No. 751/2022. See ANVISA: Medical devices and the service page Solicitar registro de dispositivo médico.

What that means after FIH:

• The applicant company must already be regularized with ANVISA (CNPJ, Solicita access). A foreign legal manufacturer does not file as itself.
• For Classes III and IV, ANVISA’s page is explicit that the manufacturing unit must hold a valid GMP certificate issued by ANVISA; the agency may accept a GMP-certification protocol at application, but effective approval depends on publication of the GMP certification. That is often the real Brazil clock—not the clinical tables.
• The service page cites RDC 751/2022 (devices) and RDC 830/2023 (IVDs) and states that a granted registro is valid for 10 years from publication in the Diário Oficial da União.

Do not reuse the trial import file for commercial launch. The trial IOR and the Brazil Registration Holder are often different companies. Align them before you translate the CSR.

INVIMA (Colombia) — I/IIA automatic vs IIB/III prior evaluation

INVIMA’s device pages describe the sanitary registration as the public document issued under Decreto 4725 de 2005 that authorizes production, import, and commercialization. See INVIMA: Dispositivos médicos y equipos biomédicos.

The operational split after FIH is class, not “did we already run a trial in Bogotá”:

• Risk I and IIA: automatic-style sanitary registrations / renewals when the file is complete.
• Risk IIB and III: prior technical-legal evaluation. INVIMA’s own normograma material on the procedure states that the Institute will process IIB and III sanitary-registration or marketing-permit requests in 90 business days once the technical and legal requirements are complete, and that a single deficiency cycle gives the applicant 90 days to respond or the request is treated as withdrawn.

FIH data helps the IIB/III file. It does not skip the holder, the unique INVIMA form, or Spanish labeling. A site that wants to keep using the device after the protocol closes has a registration problem, not an amendment.

COFEPRIS (Mexico) — trial authorization is not registro sanitario

Mexico is where sponsors most often confuse the two permits. DIGIPRiS is used for both clinical-research filings and device registros. They are still different authorizations.

COFEPRIS publishes device-authorization material at Autorización de Dispositivos Médicos and the agency home at gob.mx/cofepris. Commercial entry is a registro sanitario promoted by a Mexico Registration Holder, with Spanish labeling and a technical monograph. Equivalence / abbreviated (reliance) routes exist when you already have a reference-authority approval; those routes are not a substitute for having a holder and a Spanish dossier.

If the next FDA step is still an IDE, Mexico’s equivalence conversation is usually later. Treat trial-to-registration as its own workstream. Do not wait for a 510(k) number unless Mexico is explicitly “abbreviated after FDA.”

ANMAT (Argentina) — HELENA is the commercial desk

ANMAT’s product-medical page points commercial filings to Sistema HELENA for electronic registration of productos médicos (including IVDs). See ANMAT: Productos Médicos and the HELENA login at helena.anmat.gob.ar.

HELENA is not your ethics committee. After FIH you need a locally enabled manufacturer/importer, a class-correct expediente, and Spanish files. Argentina looks “slow” when company habilitation and digital signature start after the CSR.

A post-FIH sequence that does not fight itself

A sequence I use when first patients are in and the board wants both a U.S. story and a LATAM revenue story:

1. Week 0–2 after first-patient-in: freeze the commercial identity. Intended use, models, accessories, software baseline, sterile barrier, and the claims you are willing to put on a label. If the next three patients will change the device, you are still in design, not in registration.
2. Week 2–6: stand up holders in the countries you will actually sell, not the countries you studied. A Panama or El Salvador FIH does not create an ANVISA or COFEPRIS registration. Pick the commercial four (or a subset) and appoint holders while enrollment continues.
3. In parallel: FDA use-case for the same data. If the next U.S. step is an IDE, write the IDE as the primary consumer of the FIH package (GCP statement, IEC packet, monitoring, device accountability). If the next U.S. step is 510(k)/De Novo, decide whether FIH is supporting clinical evidence or only human-factors/feasibility color. That choice changes how hard you should push LATAM registration on interim data.
4. Stagger the four LATAM files by what they wait on, not by national pride.
   • INVIMA I/IIA and ANMAT lower-class HELENA filings can often start as soon as the holder and Spanish admin file exist—clinical depth is lighter.
   • ANVISA III/IV waits on BGMP as much as on the CSR. Start the GMP petition the week you lock the manufacturing site, not the week you lock the tables.
   • COFEPRIS standard registro can start on a complete Spanish monograph; save equivalence/abbreviated for when you actually have a reference-authority approval to lean on.
5. Do not file four countries on four different device descriptions. One source IFU, four translations. One PMS / tecnovigilancia plan architecture, four local implementations. One complaint-handling owner.

Three sequencing mistakes I still see after first implants

1. Using the trial IOR as the future registration holder “to save a contract.” Cheap in month one. Expensive when you want to change distributors, add a second importer, or survive an inspection.
2. Waiting for FDA clearance before opening any LATAM registro because “reliance will be faster.” Reliance is real in Mexico when you have something to rely on. It is not a reason to delay holder appointment, translations, or Brazil GMP.
3. Sending LATAM a marketing brochure version of the FIH while sending FDA a GCP package. Reviewers talk. More importantly, your own QMS will not survive two truths about the same study.

One tactical next step

This week, build a one-page post-FIH evidence map: FDA plus the LATAM countries you will actually file, and three rows—(1) what is locked (protocol, IEC letters, device version), (2) what is open (CSR date, GMP, holder, translations), (3) the first document each agency is waiting on that is not “more patients.” Share it with regulatory, quality, and the person who signs import paperwork. If those three people cannot point to the same configuration and the same holder, you are hoping, not sequencing.

Disclosure: I am CEO of bioaccess®, a FIH/EFS medical-device CRO and LATAM launch/in-country-holder group. The sequencing above is how I tell sponsors to think about the calendar; it is not a pitch for a particular vendor to hold your registration.