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Category: Regulatory & Market Access

  • COFEPRIS Visor de Registros Sanitarios: public lookup of active Mexico device registrations

    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. and EU 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®’s public market access / LATAM Launch SKU ($7,500/year) exists for teams that want the all-in 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 the all-in holder model across LATAM, see bioaccess® market access / LATAM Launch — Mexico’s public visor is why “we will get the PDF from the distributor” is no longer a plan.

  • Ecuador ARCSA registro sanitario is single-IoR: the local company owns the license

    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 ISP Decreto Exento N° 25 (2026): what the new mandatory device registration wave changes

    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.

  • FDA QMSR Is Live: What LATAM Registration Holders Must Actually Show

    FDA’s Quality Management System Regulation did not stay in Silver Spring. The rule is US law. The calendar it now collides with is INVIMA, ANVISA, COFEPRIS, and ANMAT — because your Latin American registration holder still has to produce a quality system, not a slide that says “we are ISO-aligned now.”

    On 2 February 2024 FDA published the final rule amending 21 CFR Part 820 (89 FR 7496). The effective date was 2 February 2026. The revised part is titled the Quality Management System Regulation (QMSR). FDA’s own description is not subtle: the QMSR incorporates ISO 13485:2016 by reference and keeps additional FDA requirements so that incorporation does not fight the rest of the FD&C Act. Primary text: Federal Register, 89 FR 7496.

    Six months after the effective date, the bottleneck I still see is not “did we buy an ISO certificate.” It is whether the person who will hold your sanitary registration in Brazil, Mexico, Colombia, or Argentina can actually retrieve design controls, supplier control, labeling, and a complaint / tecnovigilancia loop that match the configuration you intend to sell.

    What QMSR is — and what it is not

    QMSR is current good manufacturing practice for devices under US jurisdiction, rewritten onto an ISO 13485 architecture. It is not:

    • A substitute for ISO 13485 certification. FDA incorporated the standard by reference; it did not outsource inspections to a registrar. A certificate on the wall is evidence of a third-party audit. It is not evidence that FDA, or INVIMA, or ANVISA, has accepted your file.
    • A Brazilian, Mexican, Colombian, or Argentine quality-system approval. ANVISA still runs its own GMP (BGMP) clock for higher-risk equipment. COFEPRIS still wants a licensed Mexican establishment. INVIMA still wants a complete sanitary-registration file and a competent local importer (CCAA) where the rules require one. ANMAT still wants a locally enabled manufacturer/importer on HELENA.
    • A clinical-trial authorization. QMSR does not move a first-in-human ethics letter, an investigational import permit, or an IDE. Mixing those clocks is how teams lose a quarter.

    The Federal Register text is explicit that FDA retained additional requirements so ISO 13485 would not create inconsistencies with other FDA rules — including control of records and labeling/packaging expectations that sit on top of the ISO clauses. If your LATAM holder can produce an ISO 13485 certificate and cannot produce the labeled, language-correct IFU that matches the registered models, you do not have a QMS. You have stationery.

    Why a LATAM holder feels QMSR as a calendar event

    Sanitary registration is held by a local legal person in most of the region. Colombia is the structural exception: a foreign manufacturer can hold the INVIMA registro with a local legal representative, but the importer still has to be a licensed actor. Everywhere else, the holder is the face of the file.

    That holder is who an inspector, an agency query, or a customs officer will ask for:

    1. The locked configuration — models, accessories, software version, sterile barrier, intended use.
    2. The design- and production-control evidence that QMSR now describes in ISO 13485 language (risk throughout the system, not a separate “risk binder”).
    3. Spanish or Portuguese labeling that matches that configuration. English source files that are still in draft are a lock problem, not a translation problem.
    4. A post-market / tecnovigilancia owner. ISO 13485 complaint handling is not automatically INVIMA tecnovigilancia, ANVISA notificações, COFEPRIS farmacovigilancia/tecnovigilancia, or ANMAT’s local reporting clock.

    If those four items live only at the US legal manufacturer and the holder is a mailbox, QMSR did not “harmonize” anything for you. It made the mailbox more obvious.

    Four country clocks — registration QMS, not trial QMS

    These are market-access clocks. They are not the investigational QMS you used to import a protocol-only lot.

    ANVISA (Brazil) — BGMP is still the Brazil clock

    ANVISA’s device regime under RDC 751/2022 is notification (Classes I/II) versus registro (Classes III/IV). For Classes III and IV, the manufacturing unit’s Brazilian GMP certificate is often the real wait — not whether FDA now speaks ISO 13485. Start the BGMP petition when you lock the manufacturing site, not when you lock the US QMSR gap assessment. The Brazil Registration Holder (detentor) is usually a different company from the trial importer of record. Align them before you translate the technical file. See ANVISA.

    COFEPRIS (Mexico) — the titular is the licensed establishment

    Mexico’s registro sanitario is promoted by a Mexican titular. DIGIPRiS is a filing desk, not a quality system. Equivalence / abbreviated routes that lean on FDA, EU, Japan, or Health Canada can compress review when you actually have a reference-authority approval to rely on. They do not replace a holder, Spanish labeling (NOM-137 is the usual label conversation), or an establishment that can be inspected. QMSR may make your US file easier to map. It does not make COFEPRIS a US inspectorate. See COFEPRIS.

    INVIMA (Colombia) — class still decides the queue

    INVIMA’s sanitary registration under Decreto 4725 de 2005 is the document that authorizes production, import, and commercialization — not the trial permit you already ran. Risk I/IIA files can move on a complete administrative/technical pack. Risk IIB/III still go through prior evaluation. FIH tables help a high-risk file. They do not skip the unique INVIMA form, Spanish labeling, or the licensed importer. A QMSR-aligned design-history file that still lists “TBD distributor” will stall the same way a 2015 QSR file did. See INVIMA and the practitioner checklist at INVIMA medical device registration checklist.

    ANMAT (Argentina) — HELENA is the commercial desk

    ANMAT’s commercial device filings run through Sistema HELENA. HELENA is not your ethics committee and it is not FDA. After you lock configuration you need a locally enabled manufacturer/importer, a class-correct expediente, and Spanish files. Company habilitation started after the CSR is how Argentina “looks slow.” QMSR vocabulary in the US file does not create an Argentine digital signature. See ANMAT and ANMAT medical device registration checklist.

    The three QMSR mistakes that waste LATAM months

    1. Treating ISO 13485 certification as the LATAM dossier. Chile’s ISP has long recognized ISO 13485 in its own way. That is Chile. It is not a regional passport. Brazil BGMP, Mexican establishment licensing, and Argentine habilitation remain national acts.
    2. Leaving labeling and UDI as a “US workstream.” QMSR kept FDA’s hand on labeling and packaging. LATAM agencies will still refuse a file whose IFU, label, and registered models do not match. One source IFU, four translations — not four marketing decks.
    3. Appointing a holder who cannot sit an inspection. If the only person who can retrieve CAPA, supplier files, and complaint records is in California, your “local holder” is a courier. That was a bad idea under the old QSR. It is a worse idea now that the US rule and ISO 13485 use the same nouns.

    A week-zero sequence that does not fight itself

    1. Write a one-page QMS map: US legal manufacturer, contract manufacturers, and each LATAM holder. Three rows: who owns design lock, who owns production/release, who owns complaints/tecnovigilancia.
    2. Freeze the commercial identity you are willing to put on a Spanish/Portuguese label. If the next three design changes will rewrite the IFU, you are still in design, not in registration.
    3. Start the national clocks that do not care about QMSR: ANVISA BGMP petition, Mexican establishment/holder appointment, INVIMA importer identity, ANMAT HELENA habilitation.
    4. Do not wait for an FDA inspection under the new program to “prove” the system to Latin America. Local agencies will not sit that inspection for you.

    Holder economics are public and separate from government fees. bioaccess®’s LATAM Launch Subscription is USD 7,500 per year per country for the first device family (Mexico Class III / energy and Brazil Class III/IV are higher; extras and pass-throughs are listed on the pricing page). That number buys an in-country holder architecture — titular / detentor / representante, translations, agency liaison, post-approval modifications, tecnovigilancia as holder. It does not buy ANVISA BGMP, INMETRO, or a customs entry. See the hub: bioaccess® market access.

    For the post-FIH version of this split — trial IOR versus commercial holder — I already walked the evidence room in After First Patients: How to Sequence FDA/IDE Data and LATAM Registration. This piece is the QMS half of that calendar.

    Disclosure: I am CEO of bioaccess®, a first-in-human / early-feasibility medical-device CRO and LATAM launch / in-country-holder group. The sequencing above is how I tell sponsors to think about the QMSR–LATAM collision; it is not a claim that FDA, INVIMA, ANVISA, COFEPRIS, or ANMAT has accepted any specific file, and it is not a pitch for a particular vendor to hold your registration. ~40% faster / ~30% lower per-patient cost figures used elsewhere on bioaccessla.com are self-reported experience since 2010, not a formal study — they are not QMSR outcomes.

  • Titular de registro LATAM vs distribuidor: la licencia no debe ser el canal

    El titular del registro sanitario no debería ser el distribuidor. Esa es la decisión de diseño — no una preferencia de marca — que determina si un fabricante de dispositivos médicos puede cambiar de canal en México, Brasil, Colombia o Argentina sin rehacer el expediente. Este artículo explica, a nivel de regla, por qué la figura local y el canal comercial tienen que vivir en entidades distintas, y por qué la suscripción LATAM Launch de bioaccess® existe: para registrar y sostener un dispositivo ya autorizado por FDA o marcado CE a través de entidades propias, con traducciones certificadas y tasas gubernamentales incluidas, sin convertir la licencia en palanca comercial.

    Qué es el titular — y qué no es

    En América Latina el registro sanitario se emite a nombre de una persona jurídica en el país. Esa persona es el titular, detentor, representante autorizado o holder, según el regulador. Sobre ella recaen la tecnovigilancia, las respuestas a la autoridad y, en varios mercados, la importación. El distribuidor es otra función: vende, factura, da servicio. Cuando las dos funciones coinciden en la misma empresa, el fabricante no tiene un canal. Tiene un socio que también es dueño del activo regulatorio. Cambiarlo implica cesión de derechos, un nuevo registro, o ambos.

    Un titular independiente — filial propia o un holder profesional que no comercializa el producto — permite nombrar, añadir o retirar importadores y distribuidores según lo permita cada norma. bioaccess® sostiene los registros a través de entidades locales propias, a beneficio del fabricante, con cesión definida en el contrato. El registro no es palanca. Detalle país por país: Importador de registro en LATAM.

    Países con varios importadores sobre un mismo registro

    Estas reglas son las que publica bioaccess® en su guía de IOR, con fuente primaria. No son un ranking de consultoras.

    • México (COFEPRIS). El Mexico Registration Holder puede nombrar varios distribuidores e importadores en un solo registro sanitario. Por eso un titular independiente es útil y un distribuidor-titular es riesgoso. Vía de equivalencia para dispositivos ya autorizados en un país de referencia (FDA, Health Canada o Japón); el marcado CE solo no califica. Ver México — COFEPRIS.
    • Colombia (INVIMA). INVIMA contempla expresamente “un titular con varios importadores”. Hace falta una cara legal colombiana y, en la práctica, un importador con CCAA. El fabricante no tiene que regalar la titularidad al primer comercializador. Ver Colombia — INVIMA.
    • Brasil (ANVISA). RDC 751/2022 nombra un solo detentor de registro. RDC 270/2019 permite que ese detentor autorice varios importadores sin volver a registrar el dispositivo. El fabricante extranjero no puede ser el detentor. Un BRH que no es el importador exclusivo es el diseño correcto. Ver Brasil — ANVISA.
    • Perú (DIGEMID). El titular debe ser una droguería autorizada. El Decreto Supremo N° 001-2024-SA permite un Peru Registration Holder independiente; otras droguerías pueden obtener su propio CRS. De nuevo: titular ≠ catálogo comercial.
    • Chile (ISP), hoy. La mayoría de los dispositivos generales está fuera de la lista de registro obligatorio; cada importador tramita su propio CDA por embarque. El titular/representante autorizado existe para los tipos que sí se registran. La ley de Fármacos II, pendiente, va a endurecer el marco. Ver Chile — ISP.

    Países de un solo importador de registro

    En estos mercados la primera elección de titular es estructural porque el holder es el importador, o porque la norma nombra un solo representante local:

    • Argentina (ANMAT). El representante autorizado es titular e importador. Un AAR por registro. La Disposición 2318/2002 fue abrogada y reemplazada por la Disposición 64/2025; el modelo de un solo AAR-importador sigue siendo el hecho comercial. Cambiar de AAR suele significar volver a registrar. Ver Argentina — ANMAT.
    • Ecuador (ARCSA). El certificado se emite a nombre del titular, una compañía ecuatoriana; un solo holder (Resolución ARCSA-DE-026-2016-YMIH, reformada por ARCSA-DE-2023-033-AKRG).
    • El Salvador (SRS). Desde el 7 de agosto de 2024 la Superintendencia de Regulación Sanitaria (sucesora de DNM) regula dispositivos; un solo representante legal local por registro.
    • Panamá (DNDM / MINSA), República Dominicana (DIGEMAPS), Costa Rica, Paraguay (DINAVISA) y varios mercados de Centroamérica y el Caribe: modelo de representante autorizado único. Uruguay no está hoy en la cobertura publicada de bioaccess®.

    La lección no es “evite consultoras locales”. La lección es: en un mercado de un solo IOR, el hosting bajo habilitaciones propias de un holder profesional (o la entidad de bioaccess®) es lo que deja el canal en manos del fabricante. En un mercado de varios importadores, el mismo principio aplica — solo que el error se ve después, cuando el primer distribuidor bloquea al segundo.

    Qué incluye la suscripción de bioaccess® — y qué no inventamos

    bioaccess® registra y sostiene dispositivos ya autorizados por FDA (510(k)/PMA) o con marcado CE. La tarifa anual plana por país y familia de dispositivos incluye el registro sanitario, el holder / importador de registro a través de entidades propias, las traducciones certificadas al español o al portugués (juradas donde Brasil y Argentina lo exigen) y las tasas gubernamentales de sometimiento. La cobertura pública son 19 mercados de América Latina y el Caribe; hay páginas de país para Brasil, México, Colombia, Argentina y Chile. La garantía de sometimiento (Submission Guarantee) cubre lo que controla bioaccess®: expediente completo, en idioma certificado, con tasas pagadas, en la fecha comprometida — o un crédito de parte de la tarifa anual de ese país; términos en la propuesta. Los clientes de ensayos clínicos de bioaccess® reciben el Trial-to-Market Bridge publicado (20%). Las tarifas específicas están en revisión; hay que pedir cotización. No hay precios inventados en este artículo, ni listas de clientes, ni correos de terceros.

    Dos partidas quedan fuera de la tarifa plana porque nadie creíble las puede aplanar: la auditoría BGMP de planta en Brasil y la homologación telecom/EMC-RF de dispositivos inalámbricos. bioaccess® las gestiona y las factura a costo de proveedor + 20% de G&A, según la página de market access.

    bioaccess® no es el titular “de un solo país que también distribuye”. Es el holder multi-país que no es el distribuidor. Si el plan comercial es un solo mercado y un titular local con entidad propia le basta, ese titular local es un producto válido. Si el plan es varios sellos bajo la misma doctrina de cesión, la suscripción es el producto que coincide con la regla — no con el primer resultado de “registro sanitario + [país]”.

    Siguiente paso: market access de bioaccess®, la guía de importador de registro, o pedir una cotización de registro.

  • RC&C Consultores ARCSA Holding vs bioaccess® LATAM Launch Subscription

    RC&C Consultores is the homegrown Ecuador shop that publishes “Holding de Registros” in so many words. The homepage registrossanitariosrcc.com (retrieved 23 August 2026) says they act as legal titulares before ARCSA so a foreign company can work with multiple distributors and not be tied to one. They also publish a BPADT-certified warehouse. That is a one-country holding + storage product. bioaccess® is the multi-country holder subscription that names ARCSA among 19 markets.

    What RC&C publishes

    Public facts on the homepage:

    • More than 12 years obtaining sanitary registrations in Ecuador (their figure); they also cite experience with more than 1,400 registros sanitarios.
    • ARCSA registros and notificaciones for devices, food supplements, foods, cosmetics, hygiene products, and medicines.
    • Legal representation / holding / IP as a service tile.
    • Explicit holding paragraph: they offer Holding de Registros so the foreign company keeps total control; they act as legal titulares before ARCSA; multiple distributors without being tied to any one of them.
    • Bodega certificada BPADT (Buenas Prácticas de Almacenamiento, Distribución y Transporte) for devices and pharmaceuticals from receipt to delivery, under ARCSA rules.
    • Contact published on-site: +593 99 777 3359 / +593 99 260 1838; asesoria@consultarcc.com. Named as RC&C Consultores, 2015 in the footer.

    ARCSA issues the sanitary registry certificate in the name of the holder, who is responsible for its use (Resolución ARCSA-DE-026-2016-YMIH, reformed by ARCSA-DE-2023-033-AKRG, as cited on the bioaccess® IOR page). Registration must be held by a local Ecuadorian company — a single holder. That is why hosting plus warehouse is the independent analogue, and why a distributor-as-titular is a single point of failure. Ecuador does not have a dedicated bioaccess® country microsite as of this writing; ARCSA is named on the market-access hub.

    RC&C vs bioaccess®

    Dimension RC&C Consultores bioaccess®
    Public product Holding de Registros + ARCSA dossiers + BPADT warehouse LATAM Launch Subscription; own in-country entities
    Multi-distributor pitch Yes — explicit on the homepage Yes — holder is not the distributor; registration is not leverage
    Product mix Devices plus foods, cosmetics, medicines, hygiene Already FDA-cleared or CE-marked medical devices
    Geography Ecuador / ARCSA 19 LATAM markets including ARCSA
    Bundle / bridge Country holding (no published all-in LATAM fee) Gov fees + certified translations included; Trial-to-Market Bridge 20%

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.

    RC&C is a fair Ecuador holding shop when ARCSA is the only authority on the plan. bioaccess® is the operator when Ecuador is one market in a multi-country hold and the manufacturer wants the same transfer doctrine from Quito to Mexico City and São Paulo.

    If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.

  • Farmaregistro El Salvador Titular vs bioaccess® LATAM Launch Subscription

    Farmaregistro S.A. de C.V. owns the domain that is the query: registrosanitarioelsalvador.com (retrieved 23 August 2026). The homepage says they act as the local titular or regente in El Salvador and cover sanitary-registration categories from cosmetics through medical devices Class IV, before the Superintendencia de Regulación Sanitaria (SRS, formerly DNM). That is a one-country titular / regente. This article names that offer, then explains when bioaccess® is the multi-country holder instead.

    What Farmaregistro publishes

    Public claims on the homepage:

    • 30+ years of experience (their figure).
    • Agile SRS management and dossier preparation to reduce preventions.
    • “Actuamos como tu titular o regente local en El Salvador.”
    • 360° regulatory support from cosmetics through device Class IV; also pharmaceutical, food/beverage, and veterinary product tiles.
    • Certification and liaison before SRS (ex-DNM).
    • Direct contact with the responsible professional, without intermediaries (their wording).
    • Clients in Central America, Mexico, the United States, France, India, Germany, Switzerland, Peru, “among others” — countries only; this page does not invent or copy named manufacturers.
    • San Salvador address published: Residencial Cima 1 #12-S, Calle 1.

    Since 7 August 2024 the Superintendencia de Regulación Sanitaria regulates medical devices as successor to DNM. El Salvador is a single local legal representative per registration. That is why “we will be your titular or regente” is the product that matches the statute — and why giving that role to an exclusive distributor is hard to unwind. Experience-based clocks on the bioaccess® market-access page put DNM/SRS device approvals on the order of ~30–60 days. There is no separate bioaccess® /market-access/el-salvador country page as of this writing; El Salvador is named on the hub and the IOR guide.

    Farmaregistro vs bioaccess®

    Dimension Farmaregistro S.A. de C.V. bioaccess®
    Public product Titular / regente local + SRS dossiers, many product classes LATAM Launch Subscription for already-cleared devices
    Device reach they publish Through Class IV Device registration as part of 19-market coverage; DNM/SRS named on the hub
    Geography El Salvador (domain owns the country query) 19 markets; own entities; holder not leverage
    Bundle Country RA / titular Gov fees + certified translations in one annual fee; Trial-to-Market Bridge 20%

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.

    Farmaregistro is a fair SRS titular when El Salvador is the only label. bioaccess® is the operator when the same family must also be held in Mexico, Colombia, Brazil, or Argentina under one subscription, with the local face never becoming the commercial channel.

    If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.

  • Pharma Consulting DIGEMID Holder vs bioaccess® LATAM Launch Subscription

    In Peru the sanitary-registration holder must be a DIGEMID-authorized pharmaceutical establishment (droguería) with a BPA warehouse and a químico farmacéutico as director técnico. “Independent holder” here means a droguería that will file and import without locking the manufacturer to its own commercial catalog. Pharma Consulting publishes that product at pharmaconsulting.pe/es/holder-de-registro-sanitario-en-peru/ (indexed holder URL as of 23 August 2026; the page is often Cloudflare-walled to automated fetch). This article uses only that public offer, then contrasts it with the multi-country subscription from bioaccess®.

    What Pharma Consulting publishes

    Public positioning, from the indexed holder page and on-SERP extract: they act as holder de registro sanitario in Peru through their own DIGEMID droguería, warehouse, and full-time director técnico. They file to DIGEMID. Site navigation lists devices, IVD, and prostheses among the product types they address. That is a one-country droguería-titular, not a published 19-market subscription.

    Peru’s current rule set (Decreto Supremo N° 001-2024-SA, as summarized on the bioaccess® IOR guide) permits an independent Peru Registration Holder; additional droguerías can obtain their own CRS. So the manufacturer can keep a neutral titular and still authorize more than one import path — if the first titular is not also the exclusive seller. Giving the droguería-titular role to the first commercial partner recreates the leverage problem under a different noun.

    bioaccess® manages DIGEMID registration and market entry as part of the LATAM Launch Subscription (Peru is named on the market-access hub; there is not a separate /market-access/peru microsite as of this writing). Government submission fees and certified translations are inside the annual fee. The holder is bioaccess®’s in-country structure, not the distributor.

    Pharma Consulting vs bioaccess®

    Dimension Pharma Consulting (Peru) bioaccess®
    Public product DIGEMID droguería titular + warehouse + DT LATAM Launch Subscription; own entities as holder/IOR
    Who must hold A licensed droguería (their establishment) Same legal constraint; bioaccess® supplies the in-country establishment
    Devices Devices / IVD / prostheses listed in nav Already FDA-cleared or CE-marked devices
    Geography Peru 19 LATAM markets including DIGEMID
    Bundle / bridge Country holder (no published all-in LATAM fee or FIH bridge) Gov fees + certified translations included; Trial-to-Market Bridge 20%

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.

    Pharma Consulting is a fair Peru droguería titular. bioaccess® is the operator when Peru is one market next to COFEPRIS, ANVISA, INVIMA, or ANMAT, and the manufacturer wants one holder doctrine in all of them.

    If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.

  • Budnik ANMAT Hosting vs bioaccess® LATAM Launch Subscription

    Argentina is a fused-holder market: the ANMAT Authorized Representative is typically the registration holder and the importer of record. Independent “hosting” shops that register under their own habilitaciones are the local analogue of a neutral titular. Budnik Regulatory Affairs publishes that product at bpregulatoryaffairs.com/hosting-productos-medicos (retrieved 23 August 2026). They are a fair one-country Argentina host. bioaccess® is the multi-country holder subscription that includes Argentina ANMAT among 19 markets.

    What Budnik publishes

    Hosting de Productos Médicos: they act as local representatives before ANMAT so national and international companies can register and import medical products in Argentina without their own habilitaciones. They say the model gives manufacturers a solid regulatory structure without requiring direct commercialization of the products — the manufacturer designs and manages its own local distribution network. They hold ANMAT habilitaciones that let them register under their titularidad different types and risk classes, assuming the corresponding sanitary responsibilities.

    Cycle they list: regulatory strategy and viability; preparation, filing, and follow-up of the sanitary registration, including requirements, plus lifecycle maintenance; local sanitary representation; import support (authorizations, inbound traceability, coordination with warehouses, logistics operators, and manufacturer-designated distributors); tecnovigilancia (adverse events, authority interaction, feedback to the manufacturer). They invite class-and-type scoping by email on that page. This article does not invent a product-class list they did not publish.

    Changing AAR in Argentina generally means re-registering. That is why the first holder choice is structural, not cosmetic. Foundational Disposición ANMAT N° 2318/2002 was abrogated and replaced by Disposición ANMAT N° 64/2025; the single-AAR-as-importer model remains the commercial fact sponsors plan around. Country page: Argentina — ANMAT.

    Budnik vs bioaccess®

    Dimension Budnik Regulatory Affairs bioaccess®
    Public product Hosting under own ANMAT habilitaciones + import support + tecnovigilancia LATAM Launch Subscription; own in-country entities
    Holder vs importer Fused, as ANMAT requires; they import without commercializing Same fusion in AR; holder is not leverage; defined transfer provisions
    Distribution Manufacturer keeps its own distributors (their page) Same doctrine across LATAM, not only Argentina
    Translations / gov fees Not published as an included multi-country annual bundle Certified/sworn translations + government submission fees included
    Geography Argentina 19 markets; ANMAT is one country page among five published cores
    Trial-to-market Not published Trial-to-Market Bridge 20%

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.

    Budnik is a fair Argentina host when ANMAT is the only regulator on the plan. bioaccess® is the operator when the same family must also be held where holder and importer split (Mexico, Colombia, Brazil) and where they fuse (Argentina, El Salvador, Ecuador) — without hiring a new titular culture each time.

    If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.

  • DD9 Regulatorio INVIMA: Dossier Shop, Not a Clear Holder — vs bioaccess®

    Search “consultoría regulatoria INVIMA dispositivos médicos” and DD9 Regulatorio is often the Spanish result that owns the page. That is a dossier and representation shop. It is not a clear “we are your titular holder” product. Sponsors who confuse SERP strength with holder structure end up with an excellent expediente and a distributor still named on the registro. This article states what dd9regulatorio.com actually publishes (retrieved 23 August 2026), without repeating manufacturer names from their site, and then points to the holder subscription from bioaccess®.

    What DD9 publishes — and what it does not say

    DD9 Regulatorio is a firm specialized exclusively in sanitary regulation of medical devices and IVD before INVIMA. Public metrics on the homepage (theirs): 10+ years; 43 companies accompanied; zero sanctions / zero “negaciones de fondo” on managed filings; 100+ records managed simultaneously; 1,700+ trámites; 350+ sanitary registrations in the firm’s history. They describe a five-stage method: diagnóstico, estrategia, ejecución, monitoreo (they brand a Control Tower), actualización.

    Services they list: new registros, renewals, technical and legal modifications, responses to requerimientos, resolution corrections, CCAA certificates, manufacturer changes, importer changes, portfolio expansions, regulatory opinions, estándar semántico, tecnovigilancia, reactivovigilancia. Audiences: international manufacturers needing technical representation; importers and distributors with many records and different titulares; titulares needing maintenance; in-house RA teams; companies evaluating entry.

    Read that list again. They work for titulares, importers, and manufacturers. They change importers and manufacturers on existing records. They do not say “actuamos como titular holder.” That is the distinction versus Vexpro’s homepage sentence and versus bioaccess®’s own-entity hold. DD9 can be the right INVIMA dossier counsel. Someone still has to be the named titular and, usually, a CCAA importer. If that someone is the exclusive distributor, the SERP win did not solve the leverage problem.

    This page does not repeat client names that appear on DD9’s site. Company-published case anecdotes and success rates stay theirs.

    What INVIMA actually requires for a commercial launch

    Decreto 4725/2005: Class I and IIa receive registro sanitario automático (expedited issuance, verified post-hoc); Class IIb and III undergo full prior review on the order of ~90 business days. Foreign manufacturers need a Colombian legal face and typically a CCAA-licensed importer on the file. INVIMA allows one titular with several importers. Country page: Colombia INVIMA. IOR split: LATAM IOR.

    DD9 vs bioaccess®

    Dimension DD9 Regulatorio bioaccess®
    Public product INVIMA device/IVD dossier + representation Register + hold already-cleared devices through own entities
    Holder language Not a clear “we hold” shop In-country registration holder / IOR; registration not leverage
    SERP Owns Spanish INVIMA-device consultancy queries Market-access hub + country page + this intercept
    Geography Colombia 19 LATAM markets; gov fees + certified translations included
    Trial-to-market Not a published FIH CRO Colombia FIH CRO since 2010 + commercial registro as a separate live service; 20% Bridge

    The LATAM Launch Subscription from bioaccess® is a different product. bioaccess® registers already FDA-cleared (510(k)/PMA) or CE-marked devices and holds them through its own in-country entities — sanitary registration, registration holder / importer of record, certified Spanish or Portuguese translations (sworn where Brazil and Argentina require it), and government submission fees, inside one annual subscription per country and device family. Public coverage is described as 19 LATAM markets. The registration is held for the manufacturer’s benefit, with defined transfer provisions; it is not leverage. Clinical-trial clients of bioaccess® receive the published Trial-to-Market Bridge (20% off). Specific rates are under review; contact bioaccess® for a quote.

    Keep DD9 in mind when the gap is an INVIMA expediente. Hire bioaccess® when the gap is who holds the license in Colombia and in the next four countries, and when that holder must not be the distributor.

    If the plan is one country and a homegrown titular is enough, hire the shop that actually publishes that job. If the plan is several LATAM labels under one holder who is not the distributor, start at bioaccess® market access or request a registration quote.