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Every early-stage MedTech founder I meet has a slide that shows the “fastest” first-in-human destination in Latin America. The number on that slide is almost never the number that decides whether the study finishes. The number that decides it is whether the ethics clock, the import path, the investigator calendar and the patient pipeline all clear in the same month. When they do not, paper speed becomes calendar debt.

I’m Julio Martinez-Clark, CEO of bioaccess®. We have run first-in-human and early-feasibility device programs across Latin America since 2010. This article is about the trade-off founders actually face once the destination shortlist is on the board: absolute clock speed versus regulatory and operational certainty. It is not another tour of country gates. We already published that comparison as the LATAM rapid-startup archetypes series (Chile and Costa Rica pure-ethics; Panama and El Salvador parallel review). Here the question is different: what has to be true before you trust any of those clocks.

The trap of paper feasibility

Paper feasibility looks clean. A regulatory summary quotes a statutory ethics window. A site replies “we can start in 60 days.” A distributor says the import license is routine. The board hears a single number and treats it as a plan.

What breaks that plan in real programs is rarely the statute. It is the stack behind the statute:

• Hospital or site contracts that sit in a legal queue after ethics has already cleared.
• Import licenses and customs pathways for a custom or single-use delivery system that has never entered that country before.
• Competing protocol queues at the investigator’s procedure rooms, so your “activated” site has no open slots for first procedures.
• Incomplete Spanish packages that burn the first ethics cycle on queries instead of on a decision.

I have watched sponsors move to a secondary destination because the slide promised a shorter clearance, then lose a quarter waiting on an import annex or a site that had no eligible patients in the indication. The ethics letter arrived on time. First patient in did not. That is paper feasibility: a clock that only measures one desk.

If your feasibility pack does not name the ethics body, the import path, the investigator bandwidth and a concrete patient source for the protocol, you do not have a startup plan. You have a slogan.

What regulatory certainty actually means

Certainty is not the same thing as “slow.” Certainty means the review clocks are statutory or institutional, the roles of ethics and the health authority are published, and the file that leaves your team maps to those roles without improvisation.

In the fast corridor we already mapped, that looks like:

• Chile: Ley 20.120 and Decreto 114 put protocol evaluation in an accredited Comité Ético Científico (CEC) with a 45-calendar-day report clock (extendable once by 20 days for founded reasons). ISP’s role for investigational devices sits after that ethics clearance under Código Sanitario Article 111 A for provisional use authorization and import logistics — not as a second sequential ministry science queue on the protocol itself.
• Costa Rica: a CONIS-accredited CEC authorizes the biomedical research protocol under Ley 9234 and its reglamento; CONIS registration (and the statutory 3% research-budget canon) follows. There is no sequential ministry protocol-science gate in front of study start the way a classic IND path works. Costa Rica is also the Latin American country whose biomedical-research framework applies that statutory levy on the study budget; Chile’s pathway does not charge an equivalent regulator levy of that kind.
• Panama: Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) implements Titles III and IV of Ley 84 of 2019. High-risk clinical trials run ethics and MINSA evaluation in parallel through CNBI-accredited Type II committees and RESEGIS registration. Art. 102 calls for good laboratory practice (GLP) when preclinical studies are needed. Whether that covers preclinical work done abroad for a device has not been tested, so plan for GLP or a documented GLP gap analysis.
• El Salvador: SRS regulatory authorization and CNEIS ethics review operate through the coordinated SRS–CNEIS-ES submission path, so sponsors clear both desks without inventing a local process from scratch.

Those are certainty features: you can point to a published instrument and a known desk. They are not a promise that every incomplete file finishes in 30 days. Certainty is what lets you plan the non-regulatory work — contracts, import, enrollment — on the same calendar as the review.

Audit-ready data under 21 CFR 812.28 and ISO 14155

Speed is worthless if the dataset cannot support the next U.S. or European filing. For devices, FDA’s acceptance of foreign clinical investigations is framed in 21 CFR 812.28: the investigation must be well designed and well conducted, must follow good clinical practice, and FDA must be able to validate the data through an on-site inspection if needed. GCP in that rule includes independent ethics review and documented informed consent. ISO 14155 is the clinical-investigation standard most device sponsors already use to design that GCP layer.

What that means for destination choice:

• Pick sites and investigators who can produce monitoring, source, and adverse-event records that survive an FDA or Notified Body look-back.
• Do not treat a fast ethics letter as a substitute for a monitoring plan, a translation-controlled protocol package, or a data-management setup that matches the pivotal plan.
• If the FIH is meant to support an IDE, 510(k), De Novo or CE clinical evaluation, write that intended use of the data into the protocol and the quality plan before first procedure — not after the last follow-up visit.

We have written separately about whether Panama or El Salvador FIH data can support an FDA IDE, 510(k), De Novo or PMA. The short operator version: foreign data can help, but only when the investigation was built to 812.28 and ISO 14155 standards from day one.

The sequencing matrix: early speed and later depth

Most founders do not need one country to do every job. They need a sequence.

1. Early feasibility or FIH in a corridor country where ethics and authority roles are published and startup can run without a multi-quarter sequential backlog — the archetypes above.
2. Pivotal or larger confirmatory work planned in parallel for a market with depth of sites and a registration path you already intend to use commercially — often Brazil (ANVISA) or Colombia (INVIMA), sometimes Mexico (COFEPRIS).
3. Import and quality continuity so the investigational units, labeling and device accountability rules stay coherent across both stages.

That is the same design logic as a two-country FIH strategy: one market buys a clean early clock; another buys redundancy and scale. The matrix fails when the early country was chosen only for a slide number and the pivotal country was never staffed for dossier work until the FIH was already behind.

On pricing: bioaccess® does not publish fixed public FIH prices. Any budget we show on bioaccessla.com is a sample budget for a typical first-in-human trial in Latin America, not a fixed-price offer. Your protocol, risk class, sites and import path set the real number.

A practical checklist before you lock a destination

Before the board votes on a country, make someone answer these in writing:

1. Which accredited ethics body will review, and what is the published clock for a complete file?
2. What does the national authority review for this protocol — product/import only, parallel protocol evaluation, or something else — and where is that written?
3. Who holds the import license path for this specific device configuration, and has that path cleared a comparable shipment before?
4. Which investigator has open procedure capacity in the next two quarters, and where do eligible patients come from (practice panel, hospital census, referral — named, not assumed)?
5. Will the monitoring, consent and data package meet 21 CFR 812.28 / ISO 14155 expectations if FDA or a Notified Body asks later?
6. If preclinical evidence is part of the Panama file, is it GLP, or do you have a documented gap analysis written against Decreto Ejecutivo 21 Art. 102?

If any answer is “we will figure it out after ethics,” you are buying paper speed.

How we run the conversation at bioaccess®

When a founder comes to us with a destination already chosen, we stress-test the file against that checklist. When the destination is still open, we map the protocol to the corridor archetypes, then to the sequencing matrix for the next filing. The podcast Global Trial Accelerators™ is where I walk founders through the same trade-offs in public. The private work is the feasibility memo: clocks, desks, import, enrollment and data use — on one page the board can read.

Fastest clock and most certain framework are not opposites when the framework is published and the operations behind it are real. They become opposites when the clock is the only thing you measured. Measure the stack. Then pick the country.

Evaluate your trial timeline against regional benchmarks and early-phase feasibility services at bioaccessla.com, or bring the protocol to a Global Trial Accelerators™ planning conversation and we will map the sequence with you.

Short answer: in Colombia, a new software version usually goes to INVIMA as a modification of the existing registro sanitario, not a new registration, as long as you can show the change does not affect the device’s safety and effectiveness. The line you cannot cross is in Article 30 of Decreto 4725 de 2005, as substituted by Decreto 582 de 2017: no modification when the change is significant, or when it touches the design, the material, the energy source or the manufacturing process. For software, the way most sponsors trip that line is not the code. It is the claims.

We get this question every few weeks from manufacturers with registered software or software-driven devices in Colombia. Two holders asked it in the same week this month. Here is how we answer it.

Is software a medical device in Colombia?

Yes. Article 2 of Decreto 4725 de 2005 defines a medical device for human use as “cualquier instrumento, aparato, máquina, software, equipo biomédico u otro artículo similar o relacionado”, including the “programas informáticos que intervengan en su correcta aplicación”. Software that sits inside an equipo biomédico is covered too: the same article’s definition of equipo biomédico includes “los programas informáticos que intervengan en su buen funcionamiento”.

So standalone software with a medical purpose needs its own registro sanitario, and software that runs a registered device lives inside that device’s registro. Either way, when the software changes, the registro has to keep matching what you sell.

What the rule actually says

Article 30 of Decreto 4725, in the text substituted by Article 2 of Decreto 582 de 2017, sets three things:

• Modifications are processed automatically. INVIMA issues them within the term in Article 22(b) of the decree, with an after-the-fact review of the supporting documents.
• The burden is on the holder. INVIMA may approve a modification “cuando el solicitante demuestre que se trata de un cambio que no afecte la seguridad y efectividad del dispositivo médico”. You file INVIMA’s form with the technical and legal documents that support the change.
• The hard limit. The parágrafo says a registro cannot be modified when there is “un cambio significativo en el dispositivo médico que pueda afectar la seguridad y efectividad del mismo”, or when the change involves “cambios en el diseño, en la composición química del material, en la fuente de energía o en los procesos de manufactura”. In those cases you need a new registration.

“Automatic” describes the legal track, not the calendar. In our files the approval letter for a software amendment has taken weeks, not days, because the after-the-fact review still happens and INVIMA can ask questions.

How we sort software changes

This is our operator triage, not a regulation. It reflects what INVIMA has accepted in our files.

Claims are where software files go wrong

The code can change a lot and stay a modification. A single sentence in the IFU can turn it into a new registration.

The pattern we see: a registered tool says it is “not intended for diagnostic use” and supports device selection or planning. The next version adds a metric, and marketing wants to describe it as a predictor of how the patient will do. That wording moves the product from a planning aid toward a prognostic claim. Decreto 4725 classifies by intended use and risk, and when several classification rules apply, the one that leads to the higher class wins. A new prognostic purpose invites INVIMA to ask whether this is still the device it registered.

What we tell holders:

• Present new outputs the way the registered intended use already does, for example as simulation outputs that support implant selection and positioning.
• Do not present them as a standalone prediction of the patient’s outcome.
• Keep the “not intended for diagnostic use” statement in the IFU if it is there today.
• Tell us whether a metric is a new calculated output or an existing measurement that now carries a clinical claim. New outputs make the wording more important. They do not change the route on their own.

What goes in a software modification file

INVIMA’s form plus the documents that prove the change is safe. In practice we assemble:

• A change description that maps the old and new versions, function by function.
• The manufacturer’s software verification and validation summary for the new version (most manufacturers organize it around IEC 62304).
• The updated ISO 14971 risk analysis, showing no new unacceptable risks.
• Updated IFU and labeling in Spanish, with the changes marked.
• A signed manufacturer statement that the intended use, design principles and safety profile are unchanged, or a clear explanation of what changed and why it does not affect safety and effectiveness.
• Supporting publications when the change adds clinical performance claims.

File it before the new version ships in Colombia. A product on the market that no longer matches its registro is an INVIMA inspection finding waiting to happen.

When to ask INVIMA first

If the route is genuinely unclear, INVIMA accepts a written consultation to its registrations group asking whether a change can go as a modification. It adds a few weeks. We suggest it only when the holder needs the authority’s position in writing, for a business plan or a board. Most of the time a well-argued modification file, with the claims wording handled, is the faster path.

Two clocks to keep in mind

A registro sanitario for a medical device is valid for ten years from issuance (Decreto 4725, Article 31). Renewal must be filed three months before expiry, or INVIMA treats it as a new application (Article 32). A modification does not replace a renewal. If your registro expires in the next year, plan the software modification and the renewal together.

Frequently asked questions

Does every software patch need an INVIMA filing?
Only if it changes something in the registered dossier, such as the version on the label, the IFU, or a function described in the file. Keep your change log either way. INVIMA can ask for it.

Can an indications change go as a modification?
It has in our files, when the change was backed by evidence and did not alter the design or safety already authorized. The argument has to be made explicitly in the filing.

Does Brazil or Mexico work the same way?
No. Each regulator has its own change rules for software. For Mexico, see our note on COFEPRIS digital health software clearance.

Who files the modification?
The registration holder. If your registro sits with a distributor, you need them to sign, or you move the registro first. See how to transfer a registration to a new holder.

Related

• INVIMA registro for a device already FDA cleared or CE marked
• INVIMA medical device registration checklist
• Colombia INVIMA registration holder and IOR
• bioaccess® market access in Latin America

bioaccess® files INVIMA registrations, modifications and renewals for device manufacturers through our Colombian team. If you have a software release coming and a registro in Colombia, send us the draft IFU before you finalize it. Talk to bioaccess® about Colombia market access.

General information, not legal advice. Sources: Decreto 4725 de 2005, Articles 2, 22, 30, 31 and 32, with Article 30 as substituted by Decreto 582 de 2017 (INVIMA normograma). Last verified October 13, 2026.

Twice in the past week a manufacturer asked me the same question in different words. One is a global device business being separated from its parent company, and its Latin American registrations sit with the parent’s local affiliates. The other is a US-cleared, CE-marked manufacturer of hospital disposables whose registrations sit in its distributors’ names, and it wants to add or replace distributors without refiling. Both were really asking one thing: can we move the registration we already have, or do we start over?

The short answer for the four markets where most of our holder work sits (Brazil, Mexico, Colombia and Peru) is that a registration can be transferred to a new holder without re-filing the technical dossier. Every route has one thing in common, though. The current holder has to sign. If the holder will not sign, there is no transfer. There is a new registration, and a gap in supply while you wait for it.

Here is how each agency handles it, and what I tell sponsors to line up before anyone signs.

Brazil: ANVISA transfer of titularidade under RDC 903/2024

ANVISA’s rule is RDC 903/2024, which replaced RDC 102/2016. It allows a transfer of titularidade only as the result of a corporate operation (merger, spin-off, incorporation or succession) or a commercial operation, meaning a contract that transfers an asset or a set of assets. The transfer is purely administrative. The product’s technical and sanitary characteristics are frozen as they were approved just before the operation.

The mechanics are strict:

• The successor files the transfer petition and the predecessor files the cancellation petition at the same time, within 180 days. The clock starts when the corporate act is filed at the junta comercial or when the asset-transfer contract is signed. Petitions filed late are rejected (Article 26).
• ANVISA publishes the new registration number and the cancellation of the old one together in the Diário Oficial da União. The validity date does not change (Article 29). Labels, IFUs and tender files that print the old number have to be updated.
• Products regularized by notificação cannot be transferred (Article 28). The successor has to notify them again. Under RDC 751/2022 that covers Class I and II devices, so for a low-risk portfolio “transfer” really means re-notifying under the new holder.
• The petition carries the successor’s local sanitary license, so the new holder must already exist and be licensed before the 180 days run out.

The same resolution also covers the global transfer of responsibility for a clinical trial. That matters if a first-in-human sponsor is acquired mid-study in Brazil.

For a distributor switch, the commercial-operation route is a contract in which the distributor hands the registration over as an asset. It still needs the distributor’s signature on the contract and on the cancellation petition.

Mexico: COFEPRIS cesión de derechos

In Mexico the transfer is a cesión de derechos, filed as an administrative modification to the registro sanitario under the device-modification homoclave COFEPRIS-2022-022-003. What COFEPRIS checks:

• The registration must be in force or in renewal under Article 190 Bis 5 of the Reglamento de Insumos para la Salud. The current titular must be the party ceding it.
• The cesión contract must be notarized (protocolizado ante fedatario público).
• For foreign-made devices, a manufacturer’s letter of representation must name the new holder.
• You need an updated Spanish label project and the fee under the Ley Federal de Derechos.
• The cesión has to be notified to COFEPRIS within 30 business days.

The trap is the 30-day window. If the commercial deal closes and nobody is ready with the notarized contract and an apostilled manufacturer letter, you are out of time before the paperwork exists. I draft the cesión documents before the deal closes, not after.

Colombia: INVIMA cambio de titular

INVIMA treats a holder change as an automatic modification under Article 30 of Decreto 4725 de 2005, as substituted by Decreto 582 de 2017. It is granted on filing, and INVIMA reviews the documents afterward. The registration must be in force. INVIMA’s published requirements for the cesión document:

• It must state the intention to transfer and to accept the transfer, in one joint document or two separate ones.
• It must be signed by the legal representatives of both the cedente and the cesionario. Only the current titular can cede.
• It must identify the registro sanitario number, the expediente number, the product name and, where relevant, the brand.

Documents signed abroad need the formalities of Article 251 of the Código General del Proceso. The manufacturer’s authorization also has to tie the new holder to the manufacturer. One more limit: the modification route cannot carry a change that affects safety or effectiveness, such as design, materials, energy source or manufacturing process. Keep engineering changes out of the transfer file.

Peru: DIGEMID transfer under DS 016-2011-SA

Article 8 of DS 016-2011-SA says a registro sanitario can be transferred only by its titular, and only to a party that itself qualifies to hold registrations, meaning a company with sanitary authorization as a laboratorio or droguería. The party must also keep the same manufacturing facilities and conditions. The filing needs a legalized or certified (fedateada) copy of the transfer document.

In practice DIGEMID processes transfers grouped by classification, manufacturer and country. Any change requests still pending on the registration should be closed before you file. After the transfer, the new holder’s details and its Director Técnico are updated through DIGEMID’s change procedure.

What I tell sponsors before they sign anything

1. Inventory first. List every registration by country with its number, current holder, risk class, expiry and pending changes. Expired or near-expiry registrations change the plan. Mexico wants the registration in force or in renewal, Colombia wants it in force, and Peru wants pending changes closed.
2. Get the signature before you need it. Every distribution agreement should carry a cesión obligation: a cooperation clause and, ideally, a pre-agreed form of the transfer document. A distributor who holds your registro and refuses to sign leaves you with a new registration measured in months.
3. Stand up the new holder first. The new holder must be licensed in-country, have a technical director where the country requires one, and hold manufacturer letters re-issued in its name, apostilled and translated. Brazil’s 180 days and Mexico’s 30 business days do not pause while you incorporate.
4. Do not change the product during the transfer. Brazil freezes the technical characteristics and Colombia blocks safety-relevant changes on the modification route. File the transfer clean and sequence engineering changes afterward.
5. Plan labels and stock. Brazil issues a new number. Mexico needs a new label project. Stock already in the channel carries the old holder’s details, so agree with each agency and your distributors on how existing inventory is handled.
6. Move post-market duties on day one. Technovigilance and complaint handling follow the holder. The new holder’s contacts should be live the day the transfer is granted, not a quarter later.

For planning, not as a quote: with a cooperative current holder and a licensed successor, a clean transfer in our files usually takes a few weeks to a few months per country. A contested one turns into a new registration on that country’s full review timeline.

Where bioaccess® fits

bioaccess® acts as the independent registration holder in each market. The registration sits with a holder you direct under contract, not in a distributor’s name, and the transfer terms are written into the agreement up front. If you are inheriting registrations from a parent company or pulling them back from a distributor, we start with the inventory and the signature plan.

For the background on why the license should not be the channel, read the independent registration holder strategy. The country holder guides for Brazil, Mexico and Colombia, and the Peru DIGEMID registration guide, cover the first filing. When you are ready to scope a transfer, start at bioaccess® market access.

Julio G. Martinez-Clark, CEO, bioaccess®