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Category: Navigating Regulatory Landscapes in Latin America

Explores the regulatory requirements and best practices for conducting clinical trials in Latin America, focusing on medical devices and biopharmaceuticals.

  • Latamciencias Peru vs a First-in-Human Device CRO (bioaccess®)

    If you typed Latamciencias into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Latamciencias (LinkedIn company page) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What Latamciencias publishes

    Latinoamericana de Ciencias SAC (Latamciencias) is a Lima-based CRO. Its public company profile describes clinical monitoring, pharmacovigilance and regulatory affairs services. It appears as ROIC-289 in the INS register of research organizations (OIC).

    Latamciencias vs bioaccess®

    Dimension Latamciencias bioaccess®
    Core focus Peru monitoring, PV, regulatory First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial See provider site Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need Peru-based monitoring, pharmacovigilance or regulatory support, Latamciencias’ published services match.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Latamciencias, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Facts from the Latamciencias public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • INMENSA Peru vs a First-in-Human Device CRO (bioaccess®)

    If you typed INMENSA into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about INMENSA (ClinicalTrials.gov) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What INMENSA publishes

    INMENSA (Investigaciones Médicas en Salud) is a non-profit research organization in Lince, Lima, focused on HIV and infectious-disease research. It appears as ROIC-166 in the INS register of research organizations (OIC), and it is listed as a study facility on ClinicalTrials.gov records that include ACTG network and industry-sponsored infectious-disease trials.

    INMENSA vs bioaccess®

    Dimension INMENSA bioaccess®
    Core focus Non-profit HIV and infectious-disease research site First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial See provider site Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need an experienced research site for HIV or infectious-disease trials in Lima, INMENSA’s public record matches.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including INMENSA, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Facts from the INMENSA public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Peruvian Clinical Research (PCR) Peru vs a First-in-Human Device CRO (bioaccess®)

    If you typed Peruvian Clinical Research (PCR) into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Peruvian Clinical Research (PCR) (pcr.pe) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What Peruvian Clinical Research (PCR) publishes

    Peruvian Clinical Research describes itself on its Spanish-language site as a Peruvian company offering clinical research, a licensed drug warehouse (droguería), regulatory consulting and pharmacovigilance. It appears as registered research organization ROIC-117 in the INS register of research organizations (OIC). On ClinicalTrials.gov it is listed as sponsor or collaborator on studies that include a transcranial laser device study in major depressive disorder (NCT05435820, NCT06934135) and a CDC-led influenza vaccine study (NCT06054269).

    Peruvian Clinical Research (PCR) vs bioaccess®

    Dimension Peruvian Clinical Research (PCR) bioaccess®
    Core focus Peru clinical operations, droguería (importer/warehouse), PV and regulatory First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial See provider site Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need a Peru-based team that combines study operations with local import and warehousing of investigational product, PCR’s published services match.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Peruvian Clinical Research (PCR), for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Facts from the Peruvian Clinical Research (PCR) public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Gotuzzo Asociados Peru vs a First-in-Human Device CRO (bioaccess®)

    If you typed Gotuzzo Asociados into a search box, you are probably building a CRO or site shortlist for Peru. This article uses only what is public about Gotuzzo Asociados (LinkedIn company page) and compares it with bioaccess®, the First-in-Human CRO for medical devices in Latin America since 2010. It is a practitioner comparison, not a teardown.

    What Gotuzzo Asociados publishes

    Gotuzzo Asociados S.A.C. is a Lima-based (Miraflores) clinical research services firm. Its public company profile describes services such as acting as legal representative before Peru’s INS, regulatory affairs, monitoring, investigational product import and translation. It appears as ROIC-96 in the INS register of research organizations (OIC).

    Gotuzzo Asociados vs bioaccess®

    Dimension Gotuzzo Asociados bioaccess®
    Core focus Peru legal representation, regulatory, monitoring First-in-human and early feasibility studies for medical devices
    Geography Peru (Lima) Latin America, since 2010
    Device FIH track record No named device first-in-human study found on the public pages reviewed Published case studies on bioaccessla.com
    After the trial See provider site Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need an INS legal representative and local regulatory and monitoring support for a drug study in Peru, Gotuzzo Asociados’ published services match.

    If the job is a first-in-human or early feasibility study for a medical device, bioaccess® is a specialist built for exactly that, running device studies in Latin America since 2010. When the study ends, the same company can register and hold the device across the region through its market access service. Ask any CRO or site on your list, including Gotuzzo Asociados, for a named or de-identified device first-in-human study: device class, implant or not, number of patients, ISO 14155 monitoring plan and how the data was used in an FDA file.

    For the Peru regulatory path, see CRO in Peru: the First-in-Human CRO on the INS file. Other Latin American CROs are compared in the guide to first-in-human device CROs in Latin America and on the bioaccess® compare hub.

    Ready to compare a proposal? Request a first-in-human study proposal.

    Facts from the Gotuzzo Asociados public pages linked above, Peru’s INS public registers and ClinicalTrials.gov, reviewed for bioaccess® competitive research (Oct 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Your Australian First-in-Human Trial Is Enrolling Slowly: Adding a Latin American Cohort

    General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.

    Signs you are behind

    • The registered primary completion date has passed and the study still shows recruiting.
    • Sites have been added mid-study.
    • Screen-failure rates are higher than the protocol assumed.

    For the underlying math, see catchment math for Australian recruitment.

    A same-protocol second country

    See adding a Latin American country to an Australia-only NCT, and our bioaccess® vs Australia comparison for the R&D tax incentive question.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia, the Caucasus or Latin America.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
    • Time zone: 0–2 hours from U.S. Eastern.
    • U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents and investigational import permits.

    More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Vantage Clinical comparison

    Frequently asked questions

    Can I add a Latin American country to an Australian FIH?

    Yes, a second country can run under the same protocol with its own ethics and regulatory approvals.

    Will FDA accept the combined data?

    Foreign data can support FDA submissions under 21 CFR 812.28, case by case.

    Next step

    Weighing Central Asia or the Caucasus against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerator podcast to talk through your FIH plan.

  • Israeli Medtech First-in-Human Studies Abroad: Caucasus, Central Asia or Latin America

    General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.

    What the registry shows

    • Magenta Medical: NCT07293923 lists sites in Georgia and Israel.
    • Endomatic: NCT06099106 lists a site in Tashkent, Uzbekistan.
    • ENTire Medical: NCT06438185 lists sites in Uzbekistan and Israel.
    • Sanoculis: studies such as NCT05638321 list a site in Armenia.
    • Precise Bio: NCT07325097 lists sites in Armenia and Israel.

    We describe these studies only by their public registry entries and draw no conclusion about any company’s choices.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia, the Caucasus or Latin America.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
    • Time zone: 0–2 hours from U.S. Eastern.
    • U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents and investigational import permits.

    More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Vantage Clinical comparison

    Frequently asked questions

    Where do Israeli device companies run FIH studies abroad?

    Public ClinicalTrials.gov records show Israeli sponsors with sites in Georgia, Uzbekistan and Armenia, among others.

    Can Latin American FIH data support FDA submissions?

    Yes, under 21 CFR 812.28, if GCP is followed and FDA can validate the data.

    Next step

    Weighing Central Asia or the Caucasus against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerator podcast to talk through your FIH plan.

  • First-in-Human Trials in Central Asia, and When Latin America Is the Faster Second Geography

    General information, not legal or regulatory advice. Sources checked on 25 October 2026. bioaccess® is not affiliated with any company named on this page, and describes other companies only by what they publish themselves.

    U.S. and Israeli device companies are running first-in-human (FIH) studies in Uzbekistan and Kazakhstan. This page sums up what the public registry shows country by country.

    Country snapshot (ClinicalTrials.gov)

    Industry-sponsored studies with a site in each country and a start date in 2021 or later (ClinicalTrials.gov API v2, pulled 25 October 2026):

    • Uzbekistan: 36. See our Uzbekistan guide.
    • Kazakhstan: 24, mostly large pharma. See our Kazakhstan guide.
    • Kyrgyzstan, Tajikistan, Turkmenistan: no industry-sponsored studies listed on ClinicalTrials.gov in that window. That does not mean no trials run there; it means none are registered on that registry.

    Who facilitates these studies

    The registry rarely names a CRO. In Uzbekistan, the only CRO named as a collaborator on industry device studies we found is Clinical Accelerator, on four studies (e.g. NCT07811024, NCT05592392).

    One FIH, two regions

    At least one U.S. device sponsor has publicly announced a first-in-human study enrolling at centers in both Uzbekistan and Paraguay (sponsor press release, October 2025). Latin America and Central Asia are not either/or: a sponsor can enroll in both under one protocol.

    Standards and U.S. data acceptance

    The U.S. Food and Drug Administration (FDA) accepts device data from outside the United States under 21 CFR 812.28 when the study follows good clinical practice (GCP), has independent ethics review and informed consent, and FDA can validate the data. The rule is the same whether the sites are in Central Asia or Latin America.

    How Latin America compares

    • Same FDA rule: 21 CFR 812.28.
    • Published clocks: our Panama hub publishes 3–5 week ethics approval and a 6–8 week average to first patient with bioaccess® coordination; our Brazil hub publishes 6–10 weeks for ANVISA plus ethics review.
    • Time zone: 0–2 hours from U.S. Eastern.
    • U.S. continuity: bioaccess® is headquartered in Miami; its sister organization Amavita Research Services runs a Miami device and early feasibility study site.
    • Trade-offs: Spanish or Portuguese documents and investigational import permits.

    More: FIH in Chile · FIH in El Salvador · Uzbekistan · Kazakhstan · Vantage Clinical comparison

    Frequently asked questions

    Which Central Asian countries host industry device trials?

    On ClinicalTrials.gov, Uzbekistan and Kazakhstan do; Kyrgyzstan, Tajikistan and Turkmenistan had no industry-sponsored studies listed with a 2021-or-later start as of 25 October 2026.

    Will the FDA accept FIH data from Central Asia or Latin America?

    It can, under 21 CFR 812.28, if the study follows GCP and FDA can validate the data. The decision is case by case.

    Can one FIH run in Central Asia and Latin America?

    Yes. At least one U.S. device sponsor has announced an FIH study enrolling in both Uzbekistan and Paraguay.

    Next step

    Weighing Central Asia against a Latin American start? Schedule time with Julio G. Martinez-Clark, CEO of bioaccess®, or come on the Global Trial Accelerators™ podcast to talk through your FIH plan.

  • WW Trading Brazil ANVISA Holder vs bioaccess® LATAM Market Access

    WW Trading Worldwide (legal name WW Comercial Exportadora e Importadora Ltda, Varginha, Minas Gerais) is a Brazilian export and import trading company that publishes a “Holder ANVISA” regulatory hosting service for foreign companies. The service page is at wwtrading.com.br/pt/anvisa-holder, with an English version at wwtrading.com.br/en/anvisa-holder (both retrieved 23 October 2026). This article uses only what WW Trading publishes, then compares it with the multi-country market access offer from bioaccess®.

    What WW Trading publishes

    WW Trading says foreign manufacturers can rely on its Operating Authorization (AFE) with ANVISA to hold their product registrations in Brazil through an independent registration holder, so they can enter the Brazilian market without depending on a distributor. The page makes three points:

    • Your brand, your registration: the brand and the ANVISA registration belong to the foreign company, which can work with several distributors and switch partners.
    • No Brazilian branch needed: no local branch, technical director or infrastructure of your own.
    • Sanitary compliance: technical responsibility, traceability and ANVISA requirements handled by its team.

    It lists four steps: a regulatory hosting agreement, preparation and submission of the technical dossier to ANVISA under WW Trading’s active AFE, follow-up until the registration or notification is published, and letters of authorization issued to the distributors and importers you choose. Each project is quoted by category and number of products; we found no public price. The rest of the company’s site covers coffee exports, imports, customs and tax structuring, and courier services.

    The pitch fits Brazil. A foreign manufacturer without a Brazilian entity needs a local detentor do registro (Brazil Registration Holder), and a holder that is not your distributor lets you change or add importers without losing the registration. As the bioaccess® Brazil ANVISA page explains, the holder also answers ANVISA for tecnovigilancia, so who holds the registration is a long-term decision.

    WW Trading vs bioaccess®

    Dimension WW Trading (Brazil) bioaccess®
    Public product ANVISA holder / regulatory hosting under its own AFE, alongside export, import, customs and courier services Medical device registration and market access across Latin America, with holder, importer of record where applicable, and tecnovigilancia roles in the published-price countries
    Geography Brazil 19 Latin American and Caribbean markets, including Brazil
    Public pricing None published; quoted by category and number of products Brazil published: one-time registration fee of $6,750 (Class I/II) or $22,250 (Class III/IV), then an annual holder fee from year 2 of $6,000 (Class I/II) or $7,500 (Class III/IV). Published two-part pricing also for Mexico, Colombia, Peru and Argentina
    Tecnovigilancia “Technical responsibility, traceability and ANVISA requirements” managed by its team Included in the Brazil annual holder fee: adverse-event reporting to ANVISA, field safety actions and agency correspondence
    Bridge from a clinical trial None published Same firm can run the LATAM clinical trial and then hold the commercial registration

    Where each one fits

    If Brazil is the only market on the plan and an independent ANVISA holder is the whole job, WW Trading’s published offer covers it, and it makes the right point about keeping the registration in your name rather than a distributor’s.

    bioaccess® is a different product. It runs first-in-human trials and then registers devices across Latin America. In Brazil, bioaccess® acts as your neutral Brazil Registration Holder under its contract with you, working with its local partner, and the prices are published on the LATAM registration rate card. The registration fee includes initial government fees and certified or sworn translations up to a stated cap; Brazil BGMP, INMETRO and ANATEL are quoted separately. Mexico, Colombia, Peru and Argentina follow the same two-part model, and the other covered markets are quoted case by case.

    One country and a local holder is enough? Hire the shop that publishes that job. Several LATAM labels under one partner who is not your distributor? Start at bioaccess® market access or request a registration quote.

  • Choosing a First-in-Human CRO in Panama: A Checklist for Sponsors Comparing bioaccess® with QLINICO Consulting and Other Providers

    General information, not legal or regulatory advice. QLINICO Consulting is a separate, independent company. bioaccess® is not affiliated with, endorsed by, or sponsored by QLINICO Consulting, and this page does not describe, evaluate or compare QLINICO Consulting’s services. The checklist below applies equally to every provider, including bioaccess®. For information about QLINICO Consulting, contact that company directly. Regulatory requirements and timelines change; confirm them for your protocol with MINSA and your ethics committee. Last reviewed 21 October 2026.

    Sponsors planning an early clinical study in Panama will come across several providers, including bioaccess® and QLINICO Consulting. This page does not evaluate any of them; it sets out the questions we suggest asking any Panama CRO, including us, and explains where bioaccess® fits. Panama is a strong choice for first-in-human device work, and the CRO you pick shapes how fast and how cleanly that study runs.

    Why sponsors choose Panama for first-in-human studies

    In April 2026 Panama published Decreto Ejecutivo No. 21, implementing Ley 84 of 2019. Under Article 91, for clinical trials MINSA and a CNBI-accredited Type II bioethics committee (CBI) evaluate the protocol in parallel, and studies are registered on MINSA’s RESEGIS platform before they start. When the Spanish file is complete and the right committee is selected, in our experience startup has typically taken roughly 30 to 45 days; timelines vary by study and committee, so confirm them per protocol. More detail: Panama and El Salvador parallel review.

    What to check when choosing a Panama first-in-human CRO

    Ask every bidder the same questions and get the answers in writing. These are the questions we would expect a sponsor to put to bioaccess® as well.

    • First-in-human track record. Which first-in-human or early feasibility device studies has the team run, in which device classes, and can references confirm them?
    • Regulatory and ethics pathway. How will the file reach a CNBI-accredited Type II CBI, how will RESEGIS registration be handled, and who owns import permits for the investigational device?
    • Independent medical and safety oversight. Who is the named medical monitor, how are adverse events escalated, and how is medical-monitor safety review kept separate from the investigational site’s clinical team, as ISO 14155:2020 and the protocol require?
    • Insurance and sponsor representation. How are clinical trial insurance and local legal representation for a foreign sponsor arranged?
    • FDA-ready data. Will the study meet 21 CFR 812.28 and ISO 14155:2020, with an inspection-ready trial master file and source documents an English-speaking inspector can follow? See Panama and El Salvador FIH data for FDA.
    • Continuity planning. Who are the named project manager, clinical monitor and data manager for your study, and what is the written continuity plan if a team member, site or country is delayed?
    • Scope clarity. Ask each bidder to map its price to a line-item scope (regulatory, ethics, monitoring, data management, medical monitoring, insurance, importation, sponsor representation) so bids can be compared on the same basis.

    Where bioaccess® fits

    • First-in-human focus. bioaccess® is a first-in-human CRO focused on the Americas, running first-in-human and early feasibility trials for medtech, biotech, biopharma and radiopharma, with neurotechnology among its therapeutic areas.
    • FDA strategy from Miami. We plan each study around the sponsor’s FDA endgame, then run it where it moves fastest.
    • Panama pathway. We work with MINSA and with Panama’s ethics committee pathway under Decreto Ejecutivo No. 21 of 2026.
    • Latin American network. Since 2010 we have supported more than 50 client companies, work with more than 100 sites, and cover 19 Latin American and Caribbean countries for device registration and market access, so a Panama study can have a second country ready if needed. See Latin America rapid-startup archetypes.

    Frequently asked questions

    Is bioaccess® connected to QLINICO Consulting or any other Panama CRO?

    No. bioaccess® is an independent contract research organization with no affiliation with QLINICO Consulting or any other Panama provider. This page does not evaluate other providers; sponsors should obtain information about them directly.

    What should a sponsor check before choosing a CRO in Panama?

    Ask every bidder for documented first-in-human experience in your device class, how it will route the file to a CNBI-accredited Type II ethics committee and register it in RESEGIS, who provides medical monitoring and safety oversight, how insurance and local sponsor representation are handled, how the trial master file is kept inspection-ready for FDA under 21 CFR 812.28, and what the backup plan is if a single site or country slows down.

    How long does clinical trial startup take in Panama?

    Under Decreto Ejecutivo No. 21 of 2026, Article 91, MINSA and an accredited Type II ethics committee review high-risk and clinical-trial protocols in parallel. When the Spanish file is complete and the right committee is selected, in our experience startup has typically taken roughly 30 to 45 days; timelines vary by study and committee, so confirm them per protocol.

    Can first-in-human data from Panama support an FDA submission?

    Yes, when the study is designed for 21 CFR 812.28 from day one: conduct in accordance with good clinical practice (FDA recognises ISO 14155:2020 as a consensus standard, and conformance supports but does not by itself establish GCP compliance), independent ethics review, documented informed consent, monitoring, and a trial file FDA can inspect.

    Related pages

    Planning a first-in-human study in Panama? Talk to bioaccess®.

  • Solumark Costa Rica Registration Holder vs bioaccess® LATAM Market Access

    Solumark is a Costa Rican regulatory firm that publishes a “Servicio de Representación de Registros de equipo médico” for foreign companies with no office in Costa Rica. The service is described on its services page at solumarkcr.com/servicios (retrieved 21 October 2026). This article uses only what Solumark publishes, then compares it with the multi-country market access offer from bioaccess®.

    What Solumark publishes

    Solumark explains that a Costa Rican sanitary registration involves four parties: the Responsable Sanitario / Titular del Registro (a national natural or legal person), the product owner, the manufacturer, and the distributors that the registration holder authorizes to import and sell. A company without a local office must designate a registration holder to deal with the Ministry of Health for it.

    Solumark says it acts as that responsable sanitario for companies with no direct operation in Costa Rica that want to keep control of their registrations, so the rights to the registration are not handed to a distributor. The service, as published, covers:

    • Coordinating and completing the registration documents required by the Costa Rican Ministry of Health.
    • Managing changes, modifications, renewals, changes of distributor and cancellations of the registration certificate.

    Solumark states it is neutral, is not a medical device distributor in Costa Rica, and has more than 15 years of experience. It also handles cosmetics registrations and runs training workshops. We found no public price on the site.

    The pitch fits Costa Rica. As summarized in the bioaccess® LATAM registration guide, Costa Rica uses a single Costa Rica Registration Holder that imports under the registration (RTCR 505:2022; Decreto 37988-S under Ley General de Salud N° 5395) and may authorize downstream distributors. A holder that is not your distributor lets you change or add distributors without giving up the registration.

    Solumark vs bioaccess®

    Dimension Solumark (Costa Rica) bioaccess®
    Public product Responsable sanitario / registration holder service before the Costa Rican Ministry of Health, plus device and cosmetics registrations and workshops Medical device registration and market access across Latin America, with holder, importer of record where applicable, and tecnovigilancia roles in the published-price countries
    Geography Costa Rica 19 Latin American and Caribbean markets, including Costa Rica
    Product mix Medical equipment and biomedical material, cosmetics Medical devices, with a first-in-human clinical trial path before registration
    Public pricing None published Published two-part pricing for Mexico, Colombia, Brazil, Peru and Argentina (one-time registration fee, then a lower annual holder fee from year 2); Costa Rica quoted case by case
    Contract term Not published No multi-year contract required
    Bridge from a clinical trial None published Same firm can run the LATAM clinical trial and then hold the commercial registration

    Where each one fits

    If Costa Rica is the only market on the plan and an independent local registration holder is the whole job, Solumark’s published offer covers it, and it makes the right point about not ceding the registration to a distributor.

    bioaccess® is a different product. It runs first-in-human trials and then registers devices across Latin America. In Mexico, Colombia, Brazil, Peru and Argentina the pricing is published on the LATAM registration rate card: a one-time registration fee per country and class, then a lower annual holder fee from year 2, with initial government fees and certified translations included up to a stated cap. Where local law requires a local party in those countries, bioaccess® acts as registration holder, importer of record where applicable, and tecnovigilancia contact. Costa Rica and the other covered markets are quoted case by case.

    One country and a local holder is enough? Hire the shop that publishes that job. Several LATAM labels under one partner who is not your distributor? Start at bioaccess® market access or request a registration quote.