Category: Market Access Services in Latin America

Sponsors still put “Argentina” on one regulatory Gantt with a single 90-day bar. That is the mistake. A first-in-human (FIH) or early feasibility study (EFS) for a medical device in Argentina runs as an ANMAT clinical-investigation file plus independent ethics and, where required, provincial oversight. Putting the same Class III implantable on the Argentine market later is a commercial registro under the live holder/HELENA checklist. Same agency name. Different petition, different importer, different success criterion.

If the board slide says “ANMAT approved,” ask which ANMAT. Trial authorization is not a selling license. Do not put both on one Gantt labeled “Argentina.”

Two files, one agency

ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) is Argentina’s national authority for medicines, medical devices, and clinical research. It authorizes clinical investigations for devices used in-country. Ethics sits with an independent ethics committee under ISO 14155 and the Declaration of Helsinki, with provincial jurisdictions such as Buenos Aires providing additional oversight. Those are gates on the trial track, not a commercial license.

For a U.S.-based medtech sponsor, the practical split looks like this:

• Trial file: protocol, investigator brochure, informed consent in Spanish, independent ethics package, provincial filings where they apply, investigational labeling, ISO 14155 monitoring plan, and the import story for units that will only be used in the study. The Argentina clinical-trials hub already publishes a 90-business-day statutory review target; the clock pauses for RFIs, and FIH/EFS device studies often exceed that target. Treat 90 business days as a planning framework, not a guaranteed total start-up time.
• Registro file: commercial sanitary registration for Classes I–IV under Disposición ANMAT N° 64/2025, including the simplified declaración jurada (DDJJ) route for CE-marked Class I/II through HELENA, with a local authorized representative / Technical Director ANMAT will treat as responsible for that certificate. The live ANMAT medical-device registration checklist is the commercial map. It is not a first-in-human permit.

Argentina is a strict single-IoR example on the commercial track (AAR under Disp. 64/2025), already stated on the Ecuador single-IoR sibling post. That holder conversation belongs on market access. It does not clear investigational freight for a FIH.

This site does not publish ANMAT as PAHO/WHO Level 4, and it does not invent an ICH-member claim. Headline ~30% lower versus typical US/EU programs is experience since 2010, not a formal study. None of those facts convert a trial authorization into a registro.

What FDA reviewers will ask later

If the Argentina FIH is meant to support a U.S. IDE or marketing file, design the investigation so the evidence room can satisfy 21 CFR § 812.28 (acceptance of data from clinical investigations conducted outside the United States). That regulation expects GCP, independent ethics review, and a device comparable to the version you will put in front of FDA.

ISO 14155 is the device GCP bridge FDA has publicly recognized for foreign investigations. A clean ANMAT investigation letter does not replace an inspectable trial master file. Keep device accountability, deviation logs, monitoring reports, ethics correspondence, and provincial letters in one place from day one. Eligibility of foreign data under 812.28 is not a clearance prediction.

File the federal, ethics, and provincial packages in parallel when the study design allows it. Sequential filing adds calendar time the statutory 90-business-day target never promised to absorb. Do not put a single “Argentina clock” on the Gantt and call it done.

Import: investigational units are not the registro SKU

A commercial ANMAT registration number does not clear investigational kits. Do not put a cousin SKU’s registro on the airway bill “because the PI knows customs.” Name the trial importer before ethics stamps the protocol. Map every investigational model, accessory, and spare to the investigation-authorized list. Outer labels must read as investigational, with lot or serial traceability that matches the accountability log at the site.

After last patient, close investigational inventory under the trial rules. Leaving units “for the hospital” without a new sanitary path is a new regulatory event, not a courtesy. The commercial HELENA / Class I–IV track — when you actually need it — is a separate workstream with its own importer and its own authorized representative.

Holder vs distributor (commercial track only)

When you later want Argentine market access, ANMAT will look for a local face on the sanitary registration: the authorized representative / Technical Director, renewals, variations, labeling, and vigilance. A distributor who only sells stock is not automatically that holder. Argentina’s single-IoR posture makes that point sharper, not softer. If the holder relationship breaks, the registro does not quietly follow the freight forwarder — you re-file.

The market-access hub already describes ANMAT as risk-based Classes I–IV: lower-risk sworn declaration through HELENA, higher-risk several months on an experience-based clock that is not a statutory cap. Do not collapse that commercial clock into the trial 90-business-day target. Running them as one “Argentina regulatory” workstream is how teams discover, mid-enrollment, that nobody can import the commercial launch SKU.

One-page gate before first patient in Argentina

Write these lines with owners and document IDs before you book site initiation:

1. Authority map. ANMAT investigation plus independent ethics (and provincial oversight where required) for the study. Commercial registro under Disp. 64/2025 / HELENA only if a parallel market-access file is truly in scope this year.
2. Ethics + investigation sequence. Same protocol version and the same Spanish informed-consent text across federal, ethics, and provincial packages. Plan for RFI pauses on the 90-business-day statutory target.
3. Investigational importer. Legal name and the document that ties the shipment to the investigation authorization — not a commercial registro number and not a HELENA DDJJ reference.
4. Device list. Every unit that will sit in the site accountability log, including accessories.
5. ISO 14155 file owner. Who can produce monitoring, accountability, and ethics letters within 48 hours if FDA or a notified body asks.
6. Commercial holder (optional, separate). If launch is real, name the Argentine authorized representative / Technical Director and keep that file off the FIH critical path until first patient is locked.

Where teams burn weeks

Three patterns show up repeatedly on Argentina device files:

• One 90-day bar for both desks. Treating the statutory trial review target as if it also covered Classes I–IV commercial registration. The checklist is a second file. Higher-risk commercial work often runs several months on experience, not on the trial clock.
• Registro number on investigational freight. Using a commercial ANMAT certificate for a predicate or related model to move FIH units. The investigational article is not that registered product.
• One Spanish translation for both desks. The informed-consent and brochure language for ethics and the investigation is not the commercial IFU ANMAT will later lock on a registro. Mixing them creates labeling debt on both tracks.

Fix the patterns on paper before translators start. Re-translation after first patient is a protocol amendment problem, not a word-processing problem. The CRO in Argentina category page and the registration checklist already keep trial and registro apart — keep your Gantt the same way.

Practical next step

This week, split the Argentina slide into two columns: ANMAT investigation and ANMAT registro. If the same person owns both without two dossiers, two importers, and two success criteria, you do not have an Argentina plan — you have a hope. bioaccess® runs FIH/EFS execution across Latin America, including Argentina from Miami, and holds LATAM registration/IOR work as a separate market-access track; treat Argentina the same way inside your own team. Start from the clinical-trials hub for the investigation column and the ANMAT checklist for the registro column — and do not collapse them because both say ANMAT.

Registering a device in one Latin American market is a project. Registering in 19 is an operating system. The system breaks when a US or EU manufacturer treats each country as a local-distributor errand: a different titular in Mexico, a different detentor in Brazil, a different titular in Colombia, a droguería that also sells the catalog in Peru. Six months later the certificates exist and the manufacturer does not control them.

I am Julio Martinez-Clark, CEO of bioaccess®. This is the operator brief for teams that already have FDA clearance, approval, or a CE mark, and need sanitary registration across Latin America without converting the license into the distributor’s hostage. bioaccess® LATAM market access uses two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card). Chile and other markets are quoted case by case.

The distributor-as-holder trap

Every Latin American regulator ties a device registration to an in-country legal entity. That entity is the titular, detentor, representante autorizado, or registration holder. On it sit tecnovigilancia, answers to the authority, variations, and — in several markets — importation. The distributor is a different function: sells, invoices, services. When the two functions sit in the same company, you do not have a channel. You have a partner who also owns the regulatory asset. Changing the partner means cesión de derechos, a new registro, or both.

That is how the instruments are written:

• Mexico (COFEPRIS). The named titular on the Registro Sanitario is the sanitary face of the product. A Mexico Registration Holder can name several distributors and importers on one certificate — which is why an independent holder is useful and a distributor-titular is expensive to unwind. As of 20 August 2026 you can check the named titular on the public Visor de Registros Sanitarios de Dispositivos Médicos (COFEPRIS Comunicado 21/2026). If your Mexican distributor is the name the visor shows, channel termination does not move the certificate.
• Brazil (ANVISA). RDC No. 751 of 15 September 2022 names a single detentor de registro. The foreign manufacturer cannot be that detentor. RDC 270/2019 lets the detentor authorize several importers without re-registering the device. A Brazil Registration Holder that is not the exclusive importer is the correct design.
• Colombia (INVIMA). Decreto 4725 of 2005 is the sanitary-registration statute. INVIMA contemplates one titular with several importers. The manufacturer does not have to hand titularidad to the first commercializer.
• Peru (DIGEMID). The titular must be an authorized pharmaceutical establishment, typically a droguería, under Ley N° 29459 and Decreto Supremo N° 016-2011-SA. Decreto Supremo N° 001-2024-SA lets an independent Peru Registration Holder sit apart from the distributor; other droguerías can obtain their own CRS to import a product already registered by another titular. The live Peru DIGEMID page already states that model.
• Argentina (ANMAT). One authorized representative per registro; that representative is titular and importer. Disposición 2318/2002 was replaced by Disposición 64/2025. Changing AAR usually means registering again. The same single-representative logic applies in Ecuador (Resolución ARCSA-DE-026-2016-YMIH, as amended by ARCSA-DE-2023-033-AKRG), El Salvador (SRS), Panama (Ley 90 of 2017 and Decreto Ejecutivo No. 490 of 4 October 2019), and DIGEMAPS in the Dominican Republic.

bioaccess® holds registrations for the manufacturer’s benefit (in Colombia through its own Colombian entity; elsewhere with its local partner), with defined transfer provisions in the agreement. Importer rules: LATAM importer-of-record guide.

Classification logic diverges — ANVISA, COFEPRIS, INVIMA, DIGEMID

US regulatory affairs teams still paste a single “Class II” onto a multi-country tracker. That is how dossiers bounce. Four large desks do not share a classification statute, a class count, or a review regime. A device that is Class II at FDA can be Class III at COFEPRIS because it stays in the body more than 30 days, Class III at ANVISA because it is a long-term implant, Class IIb at INVIMA, and Class III or IV at DIGEMID. Classify in each rule set. Do not infer.

Brazil — ANVISA, four classes, two regimes. RDC 751/2022 Article 5: Class I low, II medium, III high, IV maximum risk, using 22 rules in Annex I. Articles 6–7: Classes I and II go to notificação; Classes III and IV go to registro, with statutory maximums up to about 250 days (equipment), 320 days (materials), and 365 days (IVDs). Implantable and long-term surgically invasive devices default to Class III unless a specific rule says otherwise. A US 510(k) orthopedic implant does not automatically enter Brazilian notificação.

Mexico — COFEPRIS, three classes, duration-and-novelty logic. Reglamento de Insumos para la Salud, Article 83: Class I — known in medical practice, generally not introduced into the body; Class II — known in practice, generally introduced and remaining fewer than 30 days; Class III — new or recently accepted, or introduced and remaining more than 30 days. That last “or” is the trap for biomaterials and implants. The equivalence route (vía abreviada) is for devices already approved and marketed by the same manufacturer in a reference country (US FDA, Health Canada, or Japan). A CE mark alone does not qualify. Standard response times on the market-access page: about 30 / 35 / 60 working days by class I / II / III.

Colombia — INVIMA, four classes with a IIa/IIb split. Decreto 4725 of 2005, Article 5: Class I low risk, IIa moderate (special controls in manufacture), IIb high (special controls in design and manufacture), III very high risk. Class I and IIa receive registro sanitario automático. Class IIb and III undergo full prior review on the order of ~90 business days. A US “Class II” memo has to land on IIa or IIb; that choice is automatic issuance versus a 90-business-day file.

Peru — DIGEMID, four classes, separate classification regulation. Decreto Supremo N° 003-2020-SA sets classification rules and essential principles of safety and performance: Class I low, II moderate, III high, IV critical. Registration, control, and vigilance remain Decreto Supremo N° 016-2011-SA (as amended, including Decreto Supremo N° 011-2022-SA), under Ley N° 29459. DIGEMID’s device page points at Articles 124–127 for requirements by risk level. Imports run through a licensed droguería. Do not treat a Colombian Class IIa decision as a Peruvian Class II decision.

Chile (ISP), Argentina (ANMAT, Classes I–IV), Panama (GHTF/IMDRF under Ley 90 / Decreto 490), and the rest of the region add more logic, not less. The operating move is a classification matrix: one row per SKU, one column per authority, intended-purpose sentence, rule, class, regime. If those cells disagree with the US product-code memo, the US memo loses.

Consolidate independent in-country authorized representation

The alternative to 19 distributor-holders is one doctrine of local authorized representation (LAR) / registration holder, executed through dedicated in-country entities that do not sell the device. Lock these five roles per country before anyone signs a distribution LOI:

1. Who is the titular / detentor / AAR / PRH. A manufacturer branch, an independent professional holder, or the distributor. Pick one on purpose. Independent holder is the default that keeps the certificate movable.
2. Who may import. One IOR (Argentina, Panama, many single-representative markets) versus several importers on one registro (Mexico, Colombia, Brazil under RDC 270/2019, Peru via additional CRS). Write the commercial contract to the sanitary fact, not the other way around.
3. Who files tecnovigilancia and field actions. In Mexico, Brazil, and Colombia the local holder must run a named system after the certificate is granted (Ley General de Salud art. 262 Bis and NOM-240-SSA1-2012 §6.7.12; RDC 67/2009 art. 3; Resolución 4816/2008). If that system fails, the registro can be suspended or cancelled.
4. Who owns variations. Model adds, software bumps, sterile-barrier changes. Quiet EU updates do not auto-propagate into COFEPRIS, ANVISA, INVIMA, or DIGEMID.
5. Who holds the translation memory. Certified Spanish or Portuguese of IFU, labels, and technical file — sworn where Brazil and Argentina require it. If a distributor commissions the translation, they hold the glossary you will need at renewal.

bioaccess®’s published structure is that independent holder across its LATAM footprint (in Colombia through our own Colombian entity; elsewhere with our local partner). We register FDA-cleared (510(k)) or approved (PMA), or CE-marked, devices. We do not obtain FDA clearance or CE marking on your behalf. As of the July 2026 market-access card: 25+ device registrations completed; 25+ active registrations held by bioaccess®; 15+ years on COFEPRIS, INVIMA, ANVISA, and ANMAT. Figures are self-reported. If the commercial plan is one country and a local holder with its own entity is enough, that product is valid. If the plan is several certificates under the same transfer doctrine, stop hiring a new local agent per capital.

Flat-subscription maintenance versus one-off consulting fees

One-off RA consulting sells a dossier. The certificate then sits with whoever filed it, and every variation, renewal, and adverse-event clock is a new statement of work. That is how a multi-country plan becomes a stack of uncoordinated invoices.

bioaccess® pricing is two-part: a one-time registration fee per country (by device class), then a lower annual holder fee from year 2. One-time registration fee per country by class (Class I/II, IIa/IIb, III/IV): Mexico $5,000 / $8,000 / $13,250; Colombia $4,000 / $6,250 / $9,000; Brazil $6,750 / $11,500 / $22,250; Peru $4,250 / $6,500 / $10,500; Argentina $4,500 / $6,500 / $12,000. Annual holder fee from year 2: Mexico $4,500; Colombia $3,900 (our own Colombian entity holds the registration); Brazil $6,000 (Class I/II) or $7,500 (Class III/IV); Peru $4,200; Argentina $4,200. USD, excluding VAT and local taxes. Chile is quoted case by case. Prices are valid for agreements signed by 31 March 2027; this is information only, not an offer. Full table on the rate card.

Outside the flat fee: Brazil BGMP manufacturing-site audit (about USD 13,500/site), INMETRO, ANATEL, and telecom/EMC + RF homologation for wireless devices — billed at vendor cost + 20% G&A. Those telecom filings run through IFT, ANATEL, ENACOM, SUBTEL, or CRC, not the health authority. Importer-of-record logistics: quoted separately per shipment (no charge if there is no import).

Typical competitor unbundling already published on the market-access page: government fees USD 1,500–5,000 per country; translations USD 4,000–15,000; registered agent USD 3,000–5,000 per year; liaison USD 500–2,000 per month. Global RA consultancies typically quote USD 15,000–30,000 per country for registration alone. Pure Global’s published Mexico/Brazil sticker is USD 2,000–3,000 for dossier + holder (PR Newswire, 5 February 2026) — a different SKU, with no published tecnovigilancia price.

Agency queries pause any statutory period. Typical time-to-registration once the dossier is in: 90 days for low-risk devices and 120 days for Class II/III, varying by country and class.

Build the system, then pick the first three countries

1. Write the intended-purpose sentence in Spanish and Portuguese. If the team cannot agree on one sentence, stop. Classification will not survive three agencies.
2. Fill the classification matrix for ANVISA, COFEPRIS, INVIMA, and DIGEMID — then the remaining markets on the launch list. Record the rule, the class, and the regime.
3. Name the independent holder per country before any distribution LOI. Confirm, in Mexico, that the visor will show that name once the registro is vigente.
4. Separate the first-in-human file if you still need patients. Trial authorization and commercial registro are different desks. We still run first-in-human work in Colombia when the device, sites, and file fit — that is not a reason to hand INVIMA titularidad to a distributor.
5. Put maintenance on a flat annual subscription so variations, renewals, and tecnovigilancia are not a new consulting event.

Learn about bioaccess® market access at bioaccessla.com/market-access. Country pages for ANVISA, COFEPRIS, INVIMA, ANMAT, ISP, DIGEMID, and MINSA sit under that hub. Importer rules: LATAM importer of record.

On Thursday 20 August 2026, COFEPRIS published the Visor de Registros Sanitarios de Dispositivos Médicos — a public lookup of vigente (active) sanitary registrations for medical devices granted by the commission. The press piece is Comunicado de prensa 21/2026 (Ciudad de México, 20 de agosto de 2026). The tool itself sits at registros.cofepris.gob.mx/BRSDM.

If your Mexico launch memo still says “ask the distributor for a copy of the registro,” rewrite it. You can now check the named titular yourself, against a government source that updates continuously.

What the visor is — and what it is not

COFEPRIS frames the visor as part of the Plan Nacional de Autonomía Digital. Implementation is two-stage. The public and health institutions can consult and verify active sanitary registrations granted by COFEPRIS. Only records that comply with applicable legal provisions are included. The platform is dynamic: continuous updates, not a one-shot PDF dump.

Read that carefully. The visor is a public lookup of active device registrations. It does not issue a new Registro Sanitario. It does not replace a COFEPRIS application. It is not a clinical-trial database. Do not put “visor screenshot” on a board slide as if it were your authorization to sell.

Trade coverage followed a few days later (Mexico Business News, 24 August 2026). Prefer the official gob.mx cite when you brief counsel or a distributor. Secondary write-ups are useful for awareness; they are not the primary instrument.

Why the named titular matters more than the PDF

Mexico market access for commercial devices still lives or dies on who holds the Registro Sanitario — the titular / marketing registration holder (MRH). The visor makes that name checkable in public, for records COFEPRIS has placed in the vigente set.

That changes diligence:

• Independent holder vs distributor-holder. If your Mexican distributor is the titular, they control the sanitary face of the product. Channel termination does not automatically move the certificate. If a neutral Mexican company holds the registro, you can change sales partners without restarting the file as a hostage negotiation.
• Public verify before LOI. Ask for the registration number, then open the visor. Confirm the product description, the vigente status, and the named holder match the story in the LOI. Do not treat a scanned PDF from the partner’s shared drive as the only evidence.
• Hospital and tender questions. Health institutions are an explicit audience in Comunicado 21/2026. Expect purchasing and clinical-engineering teams to use the same public check. Your sales deck should match what they will see.

This is the same titular discipline bioaccess® uses across LATAM registration and importer-of-record work. Mexico’s visor simply makes the holder name harder to hand-wave.

Stage 1: titulares have a two-week observation window

Comunicado 21/2026 is explicit on stage one. Titulares of sanitary registrations may send observations, per registro, on the information shown in the visor. Use the corresponding request format and send it to digipris@cofepris.gob.mx within two weeks of the announcement.

If you are the titular — or you control the Mexican company that is — treat that clock as operational, not optional. Wrong brand name, wrong model string, or a stale legal-entity display creates downstream tender and customs friction even when the underlying authorization is fine. Log which registros you reviewed, which observations you filed, and who owns the reply from DIGIPRIS.

If your “Mexico partner” is the titular and they ignore stage one, that is a signal about how they will handle variations and tecnovigilancia later. Put it in the risk memo.

Independent holder vs distributor-holder — decide before freight

U.S. teams still sign Mexico distribution first and “sort registration later.” The visor makes the cost of that sequence visible. Before you book a launch quarter, lock four roles:

1. Who is the COFEPRIS titular. The legal face on the vigente registration the visor will show. Manufacturer’s Mexican branch, independent Mexican holder, or distributor-as-holder — pick one on purpose.
2. Who is the commercial importer of record. Freight paperwork has to align with the authorized structure. A forwarder with a borrowed tax ID is not a sanitary plan.
3. Who files tecnovigilancia and field actions. Adverse-event and safety reporting for registered devices is a local sanitary duty, not a U.S. mailbox that “will translate later.”
4. Who owns variations. Model adds, software bumps, and sterile-barrier changes need a Mexican variation path once registro exists. Quiet EU updates do not auto-propagate into the visor.

Distributor-as-titular is easy to sign and hard to unwind. Independent-holder structures cost more upfront and keep the certificate movable when the channel breaks. bioaccess® market access (two-part pricing: a one-time registration fee per country by device class, then a lower annual holder fee from year 2 (published for Mexico, Colombia, Brazil, Peru and Argentina on the rate card)) exists for teams that want an independent holder model across LATAM rather than a one-country PDF chase — Mexico’s visor is exactly why “distributor-only” plans break under diligence.

FIH in Mexico is a different workstream

A first-in-human or early-feasibility investigation in Mexico and a commercial Registro Sanitario are different files. Do not clear investigational units on a commercial registration number that does not cover the investigational configuration, and do not tell the hospital that “the visor shows we are registered, so ethics is optional.” Ethics and COFEPRIS clinical pathways keep their own calendars. Say it once and keep the columns separate on the Gantt: trial authorization on one side, commercial registro and titular on the other.

Where teams burn quarters after Comunicado 21/2026

• Treating the visor as the application desk. It verifies vigente records. It does not replace a Registro Sanitario filing.
• Accepting a distributor PDF without a public check. Open the visor. Match number, product, holder, and status to the commercial story.
• Leaving stage-one observations to “the local guy.” Two weeks from the 20 August 2026 announcement is a named window. Unfiled corrections become tender friction.
• Mixing FIH kits with commercial registro language. Investigation and selling licenses are not the same sentence, even when both mention COFEPRIS.
• Assuming every historical registration appears. COFEPRIS says only records that comply with applicable legal provisions are included, with continuous updates. Absence from the visor is a question for the titular and DIGIPRIS — not proof that a private scan is enough.

How this beats generic “Mexico registration” posts

Most content posts on Mexico device registration still recycle secondary summaries: agency overview, class language, and a soft CTA to “talk to our consultants.” Comunicado 21/2026 gives operators a primary government citation and a live URL. Use it.

When you brief a board or a hospital system, cite the gob.mx article, name the visor URL, and show the titular check you ran. That is stronger than a slide that paraphrases a consulting firm’s evergreen Mexico page. Emergo-, MedEnvoy-, and Pure Global-style explainers can still be useful background. They are not a substitute for the commission’s own announcement of a public vigente lookup.

Transparency and digitization are the framing COFEPRIS chose. Your job as sponsor is narrower: confirm the holder you think you hired is the holder the public record shows, and fund the structure that keeps that name under your control.

One-page Mexico gate this week

• List every SKU you intend to sell in Mexico in the next 24 months.
• For each SKU with an existing registro claim, open the COFEPRIS visor and record: registration number, vigente status, named titular, date checked.
• For each “yes, vigente,” name: commercial IOR, tecnovigilancia owner, variation owner — three lines, three document IDs.
• If you are the titular (or control the titular entity), file stage-one observations to digipris@cofepris.gob.mx within the two-week window using the corresponding request format — per registro.
• Separate the FIH/EFS column if you also plan Mexican patients. Different dossier, different importer, different accountability log.
• Keep the official cite in the diligence pack: gob.mx / COFEPRIS Comunicado 21/2026.

If those owners cannot point to the same intended-purpose sentence in Spanish, you are not ready to quote Mexican hospital revenue. For an independent holder model across LATAM, see bioaccess® market access — Mexico’s public visor is why “we will get the PDF from the distributor” is no longer a plan.

Ecuador is a single-holder market for medical-device sanitary registration. Resolución ARCSA-DE-2023-033-AKRG is the rule U.S. teams keep missing: the registro sanitario has to be applied for by a locally registered Ecuadorian company, and that company becomes the sole registration holder. There is no “add three distributors later and keep the certificate in Miami.”

If your LATAM launch plan still says “Ecuador: appoint a reseller and they will register,” rewrite it. The reseller may sell. The reseller is not automatically the ARCSA titular. Mixing those roles is how you hand the license to the channel.

What ARCSA actually holds

ARCSA (Agencia Nacional de Regulación, Control y Vigilancia Sanitaria) is Ecuador’s sanitary authority for devices on the commercial track. The registro sanitario is the permit to manufacture, import, store, distribute, and promote the authorized configuration. Tecnovigilancia, renewals, and variations sit with the named holder — not with a U.S. complaint desk that “will translate later.”

That is a different file from a clinical investigation. Ethics in Ecuador sits with a CEISH (Comité de Ética de Investigación en Seres Humanos). ARCSA may also see a trial petition. Those clocks are a file problem on the FIH track. They are not a waiver of sanitary registration if you later want to sell the device in Ecuador. Do not clear investigational units on a commercial registro number, and do not tell the hospital that “we have a distributor, so ethics is optional.”

A 2025 PAHO-presented package of Ecuador clinical-research rules is not, by itself, fully in force. Do not put a PAHO slide on the Gantt as if it were the current ARCSA instruction. Confirm the instrument that is actually applied before you quote an Ecuador first-patient week.

Single-IoR is the design, not a preference

bioaccess®’s published IOR-versus-holder map treats Ecuador as a single-IoR model: the sanitary registration is bound to one locally registered Ecuadorian company. You can still have downstream commercial distributors. At the regulatory level there is one accountable party per registration.

Consequence:

• If the distributor is the ARCSA holder, they control market access. Transfer depends on their cooperation and on ARCSA’s transfer path — not on your U.S. termination clause.
• If a neutral Ecuadorian company holds the certificate, you can change the sales channel without restarting the sanitary file as a hostage negotiation.
• Import paperwork that names someone other than the authorized holder/importer pair is a customs problem, not a “broker will fix it” problem.

Argentina is the other strict single-IoR example in that same map (AAR under Disposición ANMAT N° 64/2025). Ecuador is not Argentina. Do not copy the ANMAT dossier onto ARCSA. Do use the same structural question: who owns the certificate when the distributor relationship breaks?

CE Mark is evidence, not the Ecuador permit

FDA clearance and CE marking help the technical story. They do not replace ARCSA registro for a commercial SKU. Build an Ecuadorian file: Spanish labeling and IFU aligned to the intended purpose you will sell, quality evidence ARCSA’s current instruction will demand, and a local party who can answer inspections and tecnovigilancia.

Certified Spanish translations belong in that file. They are not a courtesy to the distributor. Mixing the trial informed-consent language with the commercial IFU is how both tracks pick up labeling debt.

Holder, warehouse, and tecnovigilancia

Ecuador market access fails in operations more often than in the PDF. Lock four roles before you book a launch quarter:

1. Who is the Ecuadorian company on the registro. The locally registered entity ARCSA will treat as the sole holder under Resolución ARCSA-DE-2023-033-AKRG.
2. Who is the importer of record for commercial freight. In a single-IoR market that party is usually the same legal face, or an importer the holder has actually authorized — not a freight forwarder with a borrowed tax ID.
3. Who files tecnovigilancia. Adverse-event and field-safety reporting for registered devices is a sanitary duty of the holder, not a U.S. mailbox.
4. Who owns variations. Model adds, software version bumps, and sterile-barrier changes need an Ecuadorian variation path once registro exists. Quiet EU updates do not auto-propagate.

How this interacts with FIH in Ecuador

A clinical investigation in Ecuador and a commercial ARCSA registro are still different workstreams. CEISH review and any ARCSA trial petition do not issue a selling license. Do not put first-patient kits on a commercial registration that does not cover the investigational configuration. If you also plan Ecuadorian patients, keep a separate investigation importer and a separate accountability log.

bioaccess® already runs the ARCSA / CEISH trial file as FIH work. Market access is the other column. Do not merge them because one agency acronym appears in both sentences.

Where teams burn quarters

• Distributor as titular by default. Easy to sign. Hard to unwind in a single-IoR market.
• Treating 2025 PAHO-presented trial rules as the commercial clock. Trial rules, even when in force, do not replace registro. And those 2025 slides may not be the live instrument.
• One Spanish pack for CEISH and for ARCSA registro. Consent language is not the IFU. Split the translation job.

One-page Ecuador gate this week

• List every SKU you intend to sell in Ecuador in the next 24 months.
• Name the locally registered Ecuadorian company that will apply under Resolución ARCSA-DE-2023-033-AKRG.
• Name the commercial IOR, the tecnovigilancia owner, and the variation owner — three lines, three document IDs.
• Separate the FIH/EFS column if you also plan Ecuadorian patients. Different dossier, different importer.
• Do not quote a first-patient or registro clock from a PAHO presentation until you hold the instrument ARCSA is actually applying.

If those four owners cannot point to the same intended-purpose sentence in Spanish, you are not ready to quote Ecuadorian hospital revenue. For the all-in holder model across LATAM, see bioaccess® market access / LATAM Launch — Ecuador’s single-IoR rule is exactly why “distributor-only” plans break.

Chile is no longer a “light touch if you have CE” story for every medical device. On 19 March 2026 the Ministry of Health published Decreto Exento N° 25, which adds a large set of medical devices and in vitro diagnostic devices to the mandatory sanitary-control regime under artículo 111 of the Código Sanitario. The Instituto de Salud Pública (ISP) — through its medical-device agency function (ANDIM) — is the desk that will issue and police sanitary registration for those products.

If your LATAM launch plan still says “Chile: notify and sell,” rewrite it against the decree, not against last year’s distributor memo.

What the decree actually does

Artículo 111 of the Código Sanitario already said instruments, apparatus, and related articles for diagnosis, prevention, treatment, or anatomical replacement can be placed under sanitary control by founded decree. Older decrees (including Decreto Supremo N° 825 de 1998 and later incorporation decrees such as DS N° 342/2004, DS N° 1.887/2007, DS N° 93/2018, and DS N° 42/2021 for AEDs) already pulled specific product families into ISP registration.

Decreto Exento N° 25 (signed 6 March 2026, published mid-March 2026) expands that list. Public summaries from Chilean counsel and the Ministry’s own communication describe roughly 39 additional device and IVD categories entering mandatory control, with priority on higher-risk classes (Class III/IV devices and Class C/D IVDs), products tied to ministerial care programs, and categories with tecnovigilancia signals. Software as a medical device is in scope where it meets the controlled list — do not assume SaMD is exempt because it ships as a download.

Consequence: manufacture, import, commercialization, or distribution of listed products without ISP sanitary registration is a compliance problem, not a commercial preference.

ISP registration is not a CE photocopy

ChileAtiende’s public fiche for sanitary registration of devices under mandatory control (ISP prestación code 9100003) still points sponsors to the SAFIS system with ClaveÚnica, and to prior steps many importers skip: company inscription, warehouse authorization, and the Certificado de Destinación Aduanera (CDA) path for registered devices. Registration validity is described as three years with automatic extension unless expressly revoked — confirm the current ISP instruction for your class before you put that on a board slide.

ISO certificates and a European CE certificate help the technical story. They do not replace ISP registro for products under artículo 111 control. Build the Chilean file as a Chilean file: Spanish labeling and IFU aligned to the intended purpose you will sell, quality evidence the ISP instruction will demand, and a local party who can answer inspections and tecnovigilancia.

Transition clocks — do not invent a free year

Counsel summaries of Decreto Exento N° 25 describe staggered mandatory deadlines on the order of 24 to 36 months after publication, with ISP technical instructions due within about 12 months so applicants know the exact dossier shape. Treat those as planning bands until you hold the official text and the ISP instructivo for your product codes. Voluntary early filing is the sane move for Class III/IV implants, active devices, and critical diagnostics already on the list — waiting for the last day of a transition window is how launch SKUs miss hospital tenders.

Do not tell sales “we are fine until 2029” without a product-by-product map against the decree annex and a named ISP instruction date.

Holder, warehouse, and tecnovigilancia

Chilean market access fails in operations more often than in the PDF. Lock four roles before you book a launch quarter:

1. Who is the face of the registro. The party ISP will treat as responsible for the Chilean authorization — manufacturer branch or authorized importer/distributor structure that matches how stock actually moves.
2. Who holds the bodega authorization. Registration without a legal storage story is a paper win and a customs loss.
3. Who files tecnovigilancia. Adverse-event and field-safety reporting for controlled devices sits with the sanitary duty of the local controlled party, not with a U.S. complaint desk that “will translate later.”
4. Who owns variations. Model adds, software version bumps, and sterile-barrier changes need a Chilean variation path once registro exists. Quiet EU updates do not auto-propagate.

This is the same titular discipline bioaccess® uses across LATAM registration/IOR work. Chile’s decree wave makes the gap visible because more SKUs just entered the controlled set.

How this interacts with FIH in Chile

A clinical investigation in Chile and a commercial ISP registro are still different workstreams. Do not clear investigational units on a commercial registration number that does not cover the investigational configuration, and do not tell the hospital that “Decreto 25 means we can skip ethics.” Ethics and ISP clinical pathways remain their own calendars. What the decree changes for founders is the commercial LATAM plan: Chile is now a registration-heavy market for a much wider device set.

Where teams burn quarters

Three Chile mistakes after Decreto Exento N° 25:

• Assuming CE Mark equals ISP registro. CE evidence supports the technical file. Artículo 111 control still needs ISP sanitary registration for listed products.
• Leaving SaMD and accessories off the SKU map. Controllers, patient apps, and sterile accessories often decide class and control status. Map the commercial configuration, not only the implantable core.
• Signing a distributor LOI before bodega and titular clarity. Revenue commitments without warehouse authorization and a named ISP face create tender risk, not market access.

Put the decree annex next to your Chilean forecast. If a line item is newly controlled and has no SAFIS owner, cut it from the quarter or fund the registro — do not hope customs will waive artículo 111.

One-page Chile gate this week

• List every SKU you intend to sell in Chile in the next 36 months.
• Mark each against Decreto Exento N° 25 and prior artículo 111 decrees (controlled yes/no).
• For each “yes,” name: ISP instructivo status, SAFIS owner, bodega status, CDA owner, tecnovigilancia owner.
• Separate the FIH/EFS column if you also plan Chilean patients — different dossier, different importer.

If those four owners cannot point to the same intended purpose sentence in Spanish, you are not ready to quote Chilean hospital revenue. For the all-in holder model across LATAM, see bioaccess® market access / LATAM Launch — Chile’s 2026 decree is exactly why “distributor-only” plans break.