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Category: First-in-Human

  • GMP Attestation or GMP / ISO 13485 Certificate? What LATAM First-in-Human Trials Require, Stage by Stage

    Short answer: Whether a signed manufacturer attestation is enough depends on the filing stage as much as the country. In Costa Rica, the ethics committee accepts a manufacturer’s statement of Good Manufacturing Practice (GMP) compliance. The customs-release step that follows requires an authority-issued GMP certificate. Panama and El Salvador accept a certificate or a declaration at regulator review. Chile asks for an official certificate for imported pharmaceutical products. Peru asks for a GMP certificate or a document that guarantees compliance.

    Sponsors of first-in-human (FIH) device and drug-device studies often raise this question at the feasibility stage. At bioaccess®, it is an operational item handled in study execution. For each filing, we map which quality document is required. We check that the attestation or certificate covers the right sites, product and lots. We sequence it so the import step doesn’t stall the first shipment. This guide sets out what the regulations say, with the primary source next to each requirement.

    Terms that get mixed up

    GMP attestation, declaration or constancia

    A document signed by the manufacturer, usually by its quality head or qualified person (QP), stating that the investigational product was made in compliance with GMP or under a quality management system (QMS). The regulations use different words for it: constancia (Costa Rica), declaración de buenas prácticas de fabricación de persona calificada (Panama), declaración de conformidad por parte del fabricante (El Salvador).

    GMP certificate

    A certificate issued by a health authority after it has verified a manufacturing site. Spanish-language rules call GMP buenas prácticas de manufactura (BPM) or buenas prácticas de fabricación (BPF).

    ISO 13485 certificate

    A certificate from a certification body showing that a device manufacturer’s QMS conforms to ISO 13485, the medical device QMS standard of the International Organization for Standardization (ISO). It is not the same document as a GMP certificate issued by a health authority. None of the trial-specific texts reviewed below names ISO 13485 as a mandatory document for an investigational device.

    Three filing stages, three different gates

    • Ethics committee (EC): reviews the study package, which can include a GMP statement.
    • Regulator or Ministry of Health review: evaluates the investigational product and its quality documents.
    • Import or customs release: clears each shipment, and can ask for its own quality document.

    Treat each stage as a separate checklist. A document accepted at one stage doesn’t automatically satisfy the next.

    Country-by-country: attestation or certificate?

    Country Ethics committee Regulator review Import / customs release Primary source
    Costa Rica (drugs and devices) Manufacturer constancia of GMP. Sterility certification for sterile devices. No separate product review identified in this text. The national research council (CONIS) authorizes import. Authority-issued GMP certificate for each manufacturing site, legalized or authenticated Decreto Ejecutivo 44033-S, Alcance 111, La Gaceta 106 (14 June 2023), Arts. 44(r), 55(g)(vi)
    Panama Not specified in Arts. 95–99 GMP certificate or QP GMP declaration “or equivalents” Based on RESEGIS registration, ethics approval and DNFD authorization Decreto Ejecutivo 21 of 23 April 2026, Gaceta Oficial 30510-C, Arts. 95, 99
    El Salvador (devices) Not specified in the SRS guide Manufacturer GMP certificate or manufacturer declaration of conformity. Sterility certificate where applicable. Trial import permit tied to ethics approval and SRS opinion. ISO 13485 not listed. SRS clinical-trial authorization guide, §7.2. SRS special import permits guide, §5.2.1.2
    Chile (pharmaceutical products) Accredited EC approval required before ISP authorization For imported products: official certificate from the manufacturing country’s authority confirming authorization and GMP, or another document proving GMP compliance, legalized or apostilled Customs destination certificate from ISP ISP Resolución Exenta 5.161 (Diario Oficial, 7 January 2017), Arts. 2(2), 2(8), 17
    Peru Not addressed in Annex 5 Drugs: valid GMP certificate from the country-of-origin authority, or a document that guarantees compliance. Devices: the national authority sets the documents. Not addressed in Annex 5 Decreto Supremo (DS) 021-2017-SA, Reglamento de Ensayos Clínicos, Annex 5, items 1(d) and 3

    Costa Rica: attestation at the EC, certificate at customs release

    For studies with drugs or biomedical equipment and materials (equipo y material biomédico, EMB, Costa Rica’s legal term for medical devices), the package for the ethics committee (Comité Ético Científico, CEC) must include a constancia that the product was made under GMP. Studies with sterile devices must also include a sterility certification. The requirement does not apply if a valid GMP certificate has already been filed, or to comparators. (Decreto Ejecutivo 44033-S, amending Reglamento 39061-S, Art. 44(r).)

    Import works differently. Customs release for a research product needs authorization from the Consejo Nacional de Investigación en Salud (CONIS). That filing requires a GMP certificate for each establishment involved in manufacturing, issued by the regulatory authority of the manufacturing country, as a legalized original or authenticated copy (Art. 55(g)(vi)). The same exemption applies if a valid certificate is already on file. If the manufacturing country’s authority doesn’t issue this certificate for your product, confirm the accepted alternative with CONIS for each study.

    Sourced timing: the CEC decides within one calendar month of filing (Art. 42). CONIS reviews customs-release documents within five calendar days, with one ten-business-day period to correct gaps (Art. 55(h)).

    Panama: certificate or qualified-person declaration

    For high-risk research using “medicamentos o productos para la salud humana”, the Dirección Nacional de Farmacia y Drogas (DNFD) evaluates the product before the trial starts. The filing goes through the RESEGIS research registry (Registro y Seguimiento de la Investigación para la Salud). It requires “certificados de buenas prácticas de fabricación del medicamento en investigación o declaración de buenas prácticas de fabricación de persona calificada o equivalentes”, plus a certificate of analysis and the investigator’s brochure. Import is based on RESEGIS registration, ethics approval and DNFD authorization. (Decreto Ejecutivo 21/2026, Arts. 95 and 99.)

    Article 95 is framed broadly (“products for human health”), but the document list names the investigational medicamento. For investigational devices, confirm per study which GMP or QMS document DNFD accepts.

    Sourced timing: DNFD responds within 15 business days (Art. 95).

    El Salvador: certificate or manufacturer declaration

    The Superintendencia de Regulación Sanitaria (SRS) guide for clinical-trial authorization lists device-specific requirements. They are a GMP certificate from the manufacturer “o declaración de conformidad por parte del fabricante”; a description of the manufacturing process; a manufacturer-issued sterility certificate with the sterilization method and validation (when applicable); test results; and a risk-management plan based on ISO 14971 (SRS guide, §7.2(a)–(h)). The device technical regulation separately requires the sponsor to give the principal investigator evidence (atestados) of QMS compliance for device production (Reglamento Técnico Salvadoreño, RTS 11.03.02:21, §6.1.2(d)).

    For the trial import permit, the SRS import guide lists the protocol approved by the national research ethics committee (CNEIS), the SRS favorable opinion, the current CNEIS minutes, and the inventory authorized by the SRS (§5.2.1.2). ISO 13485 appears in that guide only for other permit types, such as devices for clinical use by a health professional, where it is an alternative to authorization from the agency of origin (§5.2.1.4).

    Chile: official certificate for imported pharmaceutical products

    Chile’s Instituto de Salud Pública (ISP) authorizes the use of pharmaceutical products in clinical trials under Resolución Exenta 5.161. For imported products, the applicant must attach an official certificate from the competent health authority of the country where the manufacturing sites are located. The certificate must confirm that the manufacturer is authorized and complies with GMP under World Health Organization (WHO) recommendations, “u otro documento que acredite el cumplimiento de las Buenas Prácticas de Manufactura”, legalized or apostilled if applicable (Res. Exenta 5.161, Art. 2(8)).

    Whether a manufacturer’s own declaration counts as “otro documento” is not defined in the text, so confirm per study. The resolution covers pharmaceutical products. Whether a given drug-device combination follows this route depends on how it is classified: confirm per study. For device-only studies, see our Chile ISP device vs drug guide.

    Sourced timing: ISP rules on a customs destination certificate within three business days (Art. 17). An authorization to use a product in a trial is valid for one year and is not renewed automatically (Art. 10).

    Peru: certificate or a document that guarantees compliance

    For a drug investigational product, the trial authorization needs a valid GMP certificate for the manufacturer, issued by the competent authority of the country of origin, “o documento que garantice su cumplimiento” (DS 021-2017-SA, Annex 5, item 1(d)). For biological products and medical devices, the national medicines authority (Autoridad Nacional de Medicamentos, ANM) sets the required certificates or documents (Annex 5, item 3). Confirm per study.

    Brazil, Colombia and Argentina: verify per study. We have not yet checked the GMP or QMS document rules for Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Colombia’s Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) or Argentina’s Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) against primary sources for this guide. Confirm them against the current regulation before filing.

    What a defensible GMP or QMS attestation should contain

    None of these countries publishes a fill-in template. The checklist below follows the elements the regulations above ask about. Its structure borrows from the European Commission’s QP declaration template, which is a model, not a Latin American requirement.

    • Manufacturer letterhead, date, and the signatory’s name and role (quality head or QP)
    • Product name or code, model, and the lots or serial numbers covered
    • Every establishment involved in manufacturing and sterilization, with addresses. Costa Rica’s import step asks for each establishment.
    • The GMP or QMS standard the manufacturer complies with
    • For sterile devices, a reference to the separate sterility certificate (Costa Rica Art. 44(r); SRS guide §7.2(d))
    • Language, legalization or apostille where required (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8))

    When you need a certificate instead

    • Costa Rica, customs release: GMP certificate issued by the authority of the manufacturing country (Art. 55(g)(vi)).
    • Chile, imported pharmaceutical products: official authority certificate, or another document proving GMP compliance (Res. 5.161 Art. 2(8)).
    • Peru, drug products: country-of-origin GMP certificate, or a document that guarantees compliance (Annex 5, 1(d)).
    • Panama and El Salvador: a certificate is one of two accepted options at regulator review (DE 21 Art. 95; SRS guide §7.2(a)).

    Common sponsor mistakes

    • Assuming the EC-stage attestation also clears import. In Costa Rica it doesn’t (Art. 55(g)(vi)).
    • Sending an ISO 13485 certificate where a health authority’s GMP certificate is requested (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8)).
    • Leaving out the separate sterility certificate for sterile devices (Costa Rica Art. 44(r); SRS guide §7.2(d)).
    • Covering only the final assembly site when the text asks for every establishment (Costa Rica Art. 55(g)(vi)).
    • Skipping legalization or apostille (Costa Rica Art. 55(g)(vi); Chile Res. 5.161 Art. 2(8)).

    Timing you can plan around

    • Costa Rica: CEC decision within one calendar month (Art. 42). CONIS customs-release review within five calendar days, plus one ten-business-day correction period (Art. 55(h)).
    • Panama: DNFD response within 15 business days (DE 21/2026 Art. 95).
    • Chile: ISP customs destination certificate within three business days (Res. 5.161 Art. 17). The use authorization is valid for one year (Art. 10).

    We don’t cite timelines for El Salvador or Peru because the texts reviewed here don’t set them.

    Kickoff checklist for the quality package

    • List every manufacturing and sterilization establishment for the investigational product.
    • Decide, country by country, whether you will file an attestation, a certificate, or both.
    • Prepare a sterility certificate for sterile devices.
    • Plan for legalization or apostille where the text requires it.
    • Line up the import-stage document before the first shipment, not after ethics approval.

    Related reading: Good Laboratory Practice (GLP), GMP and sterility for early feasibility device trials · Importing investigational devices into Latin America · Investigational device import calendar · Importer of record for clinical-trial devices

    FAQ

    Do I need an ISO 13485 certificate to run a first-in-human device trial in Costa Rica, Panama, El Salvador or Chile?

    None of the trial-specific texts reviewed names ISO 13485 as mandatory. Costa Rica asks for a GMP statement at the ethics committee and an authority-issued GMP certificate at customs release. El Salvador accepts a GMP certificate or a manufacturer declaration of conformity. Panama’s device requirements and Chile’s device-only requirements should be confirmed per study.

    Is a qualified-person GMP declaration accepted in Panama?

    Yes. Decreto Ejecutivo 21 of 2026, Article 95, accepts GMP certificates or a qualified-person GMP declaration or equivalents for the investigational medicinal product. For devices, confirm the accepted document with the Dirección Nacional de Farmacia y Drogas per study.

    Does Costa Rica accept a manufacturer attestation?

    At the ethics committee, yes: Article 44(r) of the amended Reglamento 39061-S asks for a statement that the product was made under GMP, plus sterility certification for sterile devices. For customs release, Article 55(g)(vi) asks for a GMP certificate issued by the authority of the manufacturing country.

    What does Chile’s ISP accept for imported pharmaceutical products?

    Resolución Exenta 5.161 asks for an official certificate from the health authority of the manufacturing country confirming authorization and GMP compliance, or another document that proves GMP compliance, legalized or apostilled if applicable.

  • Dr. Juan Gabriel Sordo, Asenjo Institute: A Chile FIH Principal Investigator Is Not the CRO

    Sources: Arissa Medical press release of 8 October 2026 (arissamedical.com), NeuroNews International coverage of 8 October 2026 and 22 January 2024, and a ClinicalTrials.gov search run 15 October 2026. Public sources only. This page does not claim that bioaccess® ran, monitored, or advised on the Syntra study, and it does not claim the institute or its investigators as bioaccess® clients. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers.

    If you searched Dr. Juan Gabriel Sordo, Juan Gabriel Sordo first-in-human, or Syntra principal investigator Chile, you found a real investigator in the public record. Arissa Medical names Dr. Juan Gabriel Sordo, interventional neuroradiology, as principal investigator of its Syntra™ intrasaccular-device first-in-human pilot at the Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago, Chile. A principal investigator is not the CRO.

    bioaccess®’s position is simple and it is not adversarial: the investigator and the site run the cases. The First-in-Human CRO still owns ISP authorization, Law 20.120 Ethical-Scientific Committee review, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package. Emailing the PI is a good way to test investigator interest. It is not a regulatory plan.

    What the public record says

    • NeuroNews International, 22 January 2024: first patients enrolled in the first-in-human, early feasibility Syntra study; initial cases done at the Asenjo institute by principal investigator Dr. Sordo (listed with Clínica Santa María, Santiago). Source.
    • Arissa Medical, 8 October 2026: 12-month angiographic follow-up complete in all 16 pilot patients, with 15 of 16 achieving adequate occlusion and no device-related serious adverse events. Dr. Sordo is quoted as principal investigator on the device’s intrasaccular approach for wide-neck aneurysms. Source; NeuroNews coverage.
    • Oversight named: a UCLA-affiliated independent medical monitor and a blinded core lab. No CRO is named. Syntra is limited to investigational use, and the study is not listed on ClinicalTrials.gov as of 15 October 2026.

    The facility-level page is here: Instituto de Neurocirugía Asenjo, Santiago: the site is not the CRO.

    PI versus CRO

    Workstream Principal investigator First-in-Human CRO
    Clinical judgment and cases Yes Supports with protocol training and monitoring
    ISP file and amendments Signs what the site must sign Prepares, submits, and answers deficiencies
    Ethics committee packet Presents as investigator Builds the dossier and tracks the calendar
    Device import No Importer of record for the investigational device
    ISO 14155 monitoring and TMF Keeps source documents Monitors, reconciles, and closes out
    FDA 21 CFR 812.28 Provides site data Builds the foreign-data narrative for the U.S. submission

    How ISP actually works (the short version)

    Use clinical trials in Chile and Chile ISP: device vs. drug clinical trials. The Instituto de Salud Pública (ISP) governs investigational-device import and study authorization in Chile. An accredited Ethical-Scientific Committee under Law 20.120 still has to review the protocol, and a public hospital adds its own institutional authorization and research-office steps. Commercial ISP registration is a different file. Do not put trial authorization and commercial registration on one Gantt labeled “Chile.”

    All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis. Eligibility is not a guarantee of clearance or approval. See OUS FIH data and the FDA IDE.

    FAQ

    Did bioaccess® work on Dr. Sordo’s Syntra study?
    No. This page reports public sources only and claims no role in that study.

    Does bioaccess® only work in Chile?
    No. bioaccess® is the First-in-Human CRO for medical devices in Latin America since 2010, and it still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform.

    What should a neurovascular sponsor do next?
    Keep the investigator conversation going and put an operator behind it: contact bioaccess® or see First-in-Human CRO.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • Instituto de Neurocirugía Asenjo, Santiago: The Syntra FIH Site Is Not the ISP File

    Sources: Arissa Medical press release of 8 October 2026 (arissamedical.com), NeuroNews International coverage of 8 October 2026 and 22 January 2024, and a ClinicalTrials.gov search run 15 October 2026. Public sources only. This page does not claim that bioaccess® ran, monitored, or advised on the Syntra study, and it does not claim the institute or its investigators as bioaccess® clients. General information, not legal or regulatory advice. Confirm current ISP, ethics, and FDA rules with qualified advisers.

    If you searched Instituto de Neurocirugía Asenjo first-in-human, Instituto de Neurocirugía Dr. Alfonso Asenjo clinical trial, INCA Santiago neurovascular study, or “go direct to the Asenjo institute for an aneurysm device,” you found a real site. The Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago, Chile, is the public neurosurgery institute Arissa Medical names as the only site of its Syntra™ intrasaccular-device pilot. It is a serious neurovascular center. It is not a first-in-human medical-device CRO, and it is not the operator of the ISP file.

    bioaccess®’s position is simple and it is not adversarial: the institute is the site. The First-in-Human CRO still owns ISP, accredited ethics, investigational import, insurance, ISO 14155 monitoring, and the FDA 21 CFR 812.28 package, plus the option to add another Latin American country if one neurovascular center is not enough. Sponsors who skip the CRO and email the cath lab still have to rebuild that stack.

    What the public record says

    • NeuroNews International, 22 January 2024: Arissa Medical enrolled the first patients in its first-in-human, early feasibility Syntra study for wide-necked sidewall and bifurcation cerebral aneurysms. Initial cases were done at the Instituto de Neurocirugía Dr. Alfonso Asenjo in Santiago by interventional neuroradiology principal investigator Dr. Juan Gabriel Sordo. Source.
    • Arissa Medical, 8 October 2026: 12-month digital subtraction angiography follow-up was complete for all 16 patients in the prospective, single-arm pilot. The release reports 100% technical success, adequate occlusion (Raymond-Roy I–II) in 15 of 16 patients, zero retreatments, and zero device-related serious adverse events. It names the institute as the pilot site and Dr. Sordo as principal investigator, and it thanks Dr. Rodrigo Rivera, Chief of Neuroradiology, and the institute’s catheterization lab staff. Source; NeuroNews coverage.
    • Study oversight named in the release: a UCLA-affiliated independent medical monitor and a blinded core lab. The release names no CRO. Arissa says it will seek FDA Breakthrough Device designation after the pilot closes. Syntra is limited to investigational use.
    • ClinicalTrials.gov: a search on 15 October 2026 found no Syntra or Arissa record. The institute’s name does appear on older registry rows, such as the CHUM-sponsored TOBAS (NCT02098252) and PRET (NCT00626912) studies. We cite them only as facility evidence.

    That is the leak: a founder reads a 16-patient neurovascular feasibility result, sees one Santiago institute and one PI, and no CRO, and concludes the hospital ran the whole study. It did not run the regulatory stack on its own. Something always owns import, insurance, monitoring, and the dataset an FDA reviewer will ask about.

    The site is the site. The CRO is the operator.

    What a neurovascular institute can typically do when a sponsor “goes direct”:

    • Discuss investigator interest and whether the aneurysm caseload fits the protocol.
    • Share institutional ethics and research-office calendars.
    • Run the cases in its biplane cath lab with its neuroradiology team.

    What the institute is not built to own for an investigational device:

    • ISP and ethics. The investigational-device import and study authorization file, plus the Law 20.120 committee packet and every amendment.
    • Investigational import. Permits, customs, and device accountability. See importer of record for clinical trial devices in Latin America.
    • Clinical trial insurance. Required. We will not invent a premium here.
    • ISO 14155 monitoring, EDC, SAE reporting, and the TMF.
    • The 21 CFR 812.28 package. Foreign data is eligible for FDA submission and review once GCP and ethics documentation is in place. Eligibility is not clearance, and a site agreement does not produce it.

    How ISP actually works (the short version)

    Use clinical trials in Chile and Chile ISP: device vs. drug clinical trials. The Instituto de Salud Pública (ISP) governs investigational-device import and study authorization in Chile. An accredited Ethical-Scientific Committee under Law 20.120 still has to review the protocol, and a public hospital adds its own institutional authorization and research-office steps. Commercial ISP registration is a different file. Do not put trial authorization and commercial registration on one Gantt labeled “Chile.”

    All bioaccess® device protocols are run under ISO 14155 and the Declaration of Helsinki. Data is designed to be eligible for FDA submission and review under 21 CFR 812.28 on a case-by-case basis. Eligibility is not a guarantee of clearance or approval. See OUS FIH data and the FDA IDE.

    Not a critique of the hospital

    The Instituto de Neurocirugía Dr. Alfonso Asenjo is one of Chile’s reference neurosurgery centers, and the Syntra pilot shows its team can run a first-in-human neurovascular program. Use the site when the protocol fits. Hire the operator. This page is distinct from Clínica Santa María Santiago, where Dr. Sordo has also been listed, and from Clínica Alemana de Santiago. Sharing Santiago is not a license to merge them. The investigator-level page is Dr. Juan Gabriel Sordo: a Chile FIH principal investigator is not the CRO.

    bioaccess® still runs clinical trials in Colombia

    bioaccess® is the First-in-Human CRO for medical devices in Latin America, founded in 2010, with Miami headquarters and its own CRO in Colombia. bioaccess® still runs clinical trials in Colombia as well as Chile, Panama, and the rest of the platform. We pick the country the device needs.

    Frequently asked questions

    Can I contract the Instituto de Neurocirugía Asenjo directly for a device FIH?

    You can start the conversation there. The institute can discuss investigator interest, caseload, and ethics calendars. It does not become your ISP applicant, importer of record, insurer, ISO 14155 monitor, or 21 CFR 812.28 packager because it hosted a pilot. Contract the CRO, then let the CRO activate the site if the site fits.

    Did bioaccess® work on the Arissa Syntra study?

    No. This page reports public sources only and claims no role in that study.

    Is Syntra on ClinicalTrials.gov?

    Not as of a 15 October 2026 search. A sponsor-named site with no CRO in the story is exactly why this page exists.

    Next step

    If the search that brought you here was this institute, start with the operator: contact bioaccess® or see First-in-Human CRO.

    Julio G. Martinez-Clark, CEO · bioaccess®

  • How to register a medical device in Guatemala with MSPAS (Norma Técnica 37)

    Guatemala is the largest economy in Central America and one of the first markets US device companies ask me about after Mexico and Colombia. The question I hear most is “how fast is MSPAS?” The question that decides whether the launch goes well is different: whose Guatemalan license and whose power of representation sit on the file.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Guatemala file: how a medical device that is already FDA-cleared or CE-marked gets a Certificado de Inscripción Sanitaria from the Ministerio de Salud Pública y Asistencia Social (MSPAS), what goes in the dossier, and how to keep control of it. It sits next to our LATAM market-access hub, the Guatemala MSPAS country page and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

    One-sentence answer

    To import and sell a medical device in Guatemala you need a Certificado de Inscripción Sanitaria issued by MSPAS through the Sección de Autorizaciones Sanitarias de Productos Afines of the Departamento de Regulación y Control de Productos Farmacéuticos y Afines (DRCPFA), filed on form F-AS-f-08 through a Guatemalan distributor or droguería with a current Licencia Sanitaria, under Acuerdo Gubernativo 712-99 and the device technical standard Norma Técnica 37.

    The legal stack

    Guatemala regulates devices as “productos afines” rather than under a stand-alone device law. The base regulation is Acuerdo Gubernativo 712-99 of 17 September 1999, the Reglamento para el Control Sanitario de los Medicamentos y Productos Afines, amended over the years, including by Acuerdo Gubernativo 351-2006 and Acuerdo Gubernativo 104-2018. The operating detail for devices sits in Norma Técnica 37, version 5-2016, on the sanitary registration of medical devices.

    The DRCPFA publishes the current legislation and technical standards on the MSPAS medicines portal. MSPAS also notes that requirements can change with updates to technical standards, Central American technical regulations and forms. Treat any checklist, including this one, as a starting point to confirm against the current F-AS-f-08 version before you file.

    What the certificate does

    The Certificado de Inscripción Sanitaria is the document MSPAS issues to state that a device meets the current technical standards so it can be imported and sold in Guatemala. It is a commercial authorization. It does not cover study units for a first-in-human or other clinical investigation, which follow the research and ethics track described on our Guatemala clinical trials page.

    What goes in a new registration

    For a new inscription, or a renewal with a change, the MSPAS procedure lists the following:

    1. Proof of payment of the inscription fee.
    2. Form F-AS-f-08, signed, sealed and stamped by the Guatemalan responsible professional.
    3. Finished-product specifications on the manufacturer’s letterhead, signed by the manufacturer’s responsible professional.
    4. Primary and/or secondary packaging artwork.
    5. The manufacturer’s quality-control certificate for the product.
    6. A manufacturing-guarantee certificate issued by the health authority: GMP, standards approval, ISO 9001, FDA or equivalent.
    7. For foreign products, a certificate of free sale from the country of origin.
    8. A product description in Spanish.
    9. An authenticated copy of the manufacturer’s power of representation.
    10. Sealed samples, when applicable.
    11. Technical literature, catalog or insert in Spanish, when applicable.
    12. A copy of the file for the Laboratorio Nacional de Salud (LNS).
    13. A current Licencia Sanitaria for the principal distributor or droguería and for any additional distributors.

    Two rules trip up US teams. Documents issued abroad have to meet Guatemala’s legalization requirements, which in practice means apostille for Hague countries. Anything not in Spanish has to be translated by a sworn translator authorized in Guatemala, under Article 37 of the Ley del Organismo Judicial. A translation done in the US and notarized there is not the same thing.

    Renewals without changes are lighter: payment, a new F-AS-f-08, a letter from the legal representative and the responsible professional confirming the original or approved conditions still hold, and current distributor licenses.

    Where control of the registration lives

    Read item 9 and item 13 together. The manufacturer’s power of representation names who speaks for you in front of MSPAS. The distributor’s Licencia Sanitaria is what lets that company import. In Guatemala the file runs through a principal distributor or droguería, with additional licensed distributors possible. That puts the commercial decision in the power of attorney and the distribution agreement, not in the regulatory form.

    The pattern I see across Central America is the same. When a distributor offers to fund the filing, it usually ends up controlling the certificate and the import channel, and it can slow down any change when the relationship ends. Changing who holds a Guatemalan registration later is a formal procedure with MSPAS, not a letter. The cheaper path is to decide at the start who pays, whose power of representation is on file, and what the agreement says about transfer on demand.

    Timelines

    I do not publish a statutory day-count for Guatemala. Review time depends on the dossier, the product type and MSPAS workload. Build the plan around three clocks you control: apostille and sworn translation, the distributor’s license status, and how quickly your team answers observations. Confirm the current review window with MSPAS when you set a launch date.

    What this file is not

    • It is not a clinical-trial approval. Study units and commercial units follow different files.
    • It is not part of the bioaccess® fixed-price market-access subscription. That subscription runs in multi-importer model countries plus Argentina. Guatemala is quoted case by case.
    • It is not a translation shortcut. US-notarized translations do not replace a Guatemalan sworn translator.

    How bioaccess® runs Guatemala registrations

    On the live offer, bioaccess® processes Guatemala registrations funded by the manufacturer: dossier preparation against Norma Técnica 37, coordination of apostille and sworn Spanish translation, agency liaison through approval, and tecnovigilancia support. Your distributor holds the Licencia Sanitaria and imports, while the distribution agreement, reviewed by local counsel, keeps transfer-on-demand terms with you. MSPAS fees are set by the regulator and scoped pricing is confirmed at proposal. See bioaccessla.com/market-access/guatemala-mspas.

    Operator checklist before you open a Guatemala folder

    1. Confirm the distributor or droguería has a current MSPAS Licencia Sanitaria and a responsible professional who will sign F-AS-f-08.
    2. Decide who funds the filing and whose power of representation goes on file before you sign distribution terms.
    3. Start apostille on the free-sale, GMP or ISO and power-of-attorney documents early. Those are the long poles.
    4. Book a Guatemalan sworn translator for the description, labels and IFU.
    5. Check the current F-AS-f-08 version and Norma Técnica 37 requirements on the MSPAS portal.
    6. Run RF or telecom homologation for wireless devices as a separate track.
    7. Keep trial and commercial files on separate pages with separate owners.

    Talk with bioaccess® when you want a Guatemala registration filed on your terms instead of your first distributor’s.

  • How to register a medical device in Honduras with ARSA (Acuerdo 0631-ARSA-2023)

    Sponsors who ask me about Honduras usually ask the wrong first question. They ask how long ARSA takes. The better first question is which Honduran company will file, because under the current device regulation the registrant, the risk-classification report and the establishment license move together, and the registrant is the one who can keep importing.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Honduras file: how a medical device that is already FDA-cleared or CE-marked gets onto the Honduran market through the Agencia de Regulación Sanitaria (ARSA), what changed with the 2024 regulation, and where sponsors lose control of the certificate. It sits next to our LATAM market-access hub, the Honduras ARSA country page and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

    One-sentence answer

    To sell a medical device in Honduras you need an ARSA Registro Sanitario under Acuerdo No. 0631-ARSA-2023 (the Reglamento para el Control Sanitario de Dispositivos Médicos y otros Dispositivos de Interés Sanitario), filed by a Honduran registrant that holds an ARSA Licencia Sanitaria, after first obtaining an ARSA risk-classification report; the registration lasts five years.

    The rule that governs the file

    ARSA was created under Decreto 7-2021, the Ley de la Agencia de Regulación Sanitaria. Its device regulation, Acuerdo No. 0631-ARSA-2023, is dated 28 December 2023 but was published in the official gazette La Gaceta (No. 36,646) on 21 September 2024, and by its own terms entered into force twenty days after publication. If an older SOP or distributor contract cites a different effective date, fix it before you file.

    Article 5 lists the control tools ARSA uses for devices: Licencia Sanitaria for establishments, Clasificación por Riesgo, Registro Sanitario, exoneration from registration, special import authorizations, special donation authorizations and other product-specific permits. For a commercial launch you will touch at least three of them.

    Three steps in a fixed order

    1. The establishment license. The Honduran company that will import, store or distribute needs a current ARSA Licencia Sanitaria. Under Article 12 that license is issued for two, four or six years. No license, no filing.

    2. The risk-classification report. Articles 31 and 33 make the informe de Clasificación por Riesgo Sanitario a precondition of registration. The report is valid for six months and can be extended once for another six months. You file the Registro Sanitario from the date the report or its extension is issued. Sponsors who let the classification lapse while translations drag on start this step again.

    3. The Registro Sanitario. Article 33 requires a current sanitary authorization before import, storage, distribution, sale, rental, loan or advertising. Article 34 bars all of those activities without it.

    Risk classes and what each adds

    Article 29 classifies devices by intended use, anatomical site, contact duration, invasiveness and whether they deliver medicines or energy:

    • Class I — low risk, general controls.
    • Class IIA — moderate risk.
    • Class IIB — high risk.
    • Class III — very high risk, including devices that support or sustain life.

    The Class I dossier in Article 43 is the base every higher class builds on. It includes the application, a sworn declaration in ARSA’s format, a certificate of free sale, the manufacturer’s GMP certificate, quality-control specifications, a safety report that lists existing sanitary alerts, a risk-management report, the registrant’s incorporation documents, primary and secondary labels plus a complementary Honduran label, and the power granted to the lawyer when a legal representative files. Class IIA adds ISO 13485 or equivalent regulator evidence (Article 44). Class IIB adds the device-specific ISO standards, for example ISO 10993-1 or ISO 14155 (Article 45). Class III adds certified biocompatibility, stability, cytotoxicity and electrical-safety testing, plus a finished-product certificate of analysis (Article 46). Medical software has its own list, including a cybersecurity report and version history.

    The part sponsors miss: Article 40

    Article 40 permits two or more sanitary registrations for the same device from different registrant companies, as long as there is no exclusivity between the product’s titular and a Honduran distributor. If exclusivity exists, the titular has to present the document that authorizes that distributor. Article 41 stops one company from filing two registrations for an identical device.

    In practice, that makes Honduras a channel-design decision, not a paperwork exercise. If you sign an exclusive distribution agreement and let the distributor fund and file, you have handed the channel to that distributor for five years. If you keep the agreement non-exclusive and control who files, a second registrant stays possible. Read the distribution agreement and the power of attorney before you read the ARSA checklist.

    Article 39 also helps on cost: devices from the same titular and manufacturer with the same risk class, intended use, indication and generic name, or sold together as a system or kit, can sit under one Registro Sanitario.

    Validity, renewal and the dead zone

    Under Article 35 the Registro Sanitario lasts five years. Renewal has to be requested at least five months before expiry. A late renewal is possible up to three months after expiry, with the service fee plus a fine. After that window you start a new registration. Once a registration expires, the registrant cannot import or sell the device. Put the renewal date on the same calendar as your distributor review, not in a regulatory folder nobody opens.

    What this file is not

    • It is not a clinical-trial authorization. Article 42 lets ARSA issue a special authorization to import devices without a Registro Sanitario in limited cases, including devices used in clinical trials whose protocols were approved by an ARSA-authorized scientific ethics committee. That import route covers study units only. It is not a license to sell. See our Honduras clinical trials page.
    • It is not an ARSA timeline promise. I do not publish a statutory day-count for Honduras registro; confirm the current review window with ARSA when you plan the launch.
    • It is not part of the bioaccess® fixed-price market-access subscription. That subscription runs in multi-importer model countries plus Argentina. Honduras is quoted case by case.

    How bioaccess® runs Honduras registrations

    On the live offer, bioaccess® processes Honduras registrations funded by the manufacturer: risk classification, dossier assembly, certified Spanish translation of labels, IFU and technical file, agency liaison through approval, and tecnovigilancia support. Your Honduran registrant holds the Licencia Sanitaria and the responsible technical professional; your distribution agreement, reviewed by local counsel, keeps transfer-on-demand and non-exclusivity terms on your side. ARSA fees are set by the regulator and scoped pricing is confirmed at proposal. See bioaccessla.com/market-access/honduras-arsa.

    Operator checklist before you open a Honduras folder

    1. Pick the registrant first. Confirm it holds a current ARSA Licencia Sanitaria and a named responsible professional.
    2. Decide exclusive or non-exclusive before anyone files, and write the Article 40 consequence into the agreement.
    3. File the risk-classification report only when the dossier is close; you have six months plus one six-month extension.
    4. Map the FDA or CE evidence to the class-specific articles (43 to 46) instead of sending the US file as a zip.
    5. Group the family under Article 39 where the criteria fit.
    6. Calendar renewal at least five months before the five-year expiry.
    7. Run RF or telecom homologation for wireless devices as a separate track.

    Talk with bioaccess® when you want Honduras registered without giving the channel away to the first distributor that offers to pay for the filing.

  • How to register a medical device in El Salvador with SRS (former DNM)

    Sponsors still write “El Salvador DNM registration” as if the old agency name and the commercial desk were the whole story. Since 7 August 2024 the Superintendencia de Regulación Sanitaria (SRS) holds the competencies that sat with the Dirección Nacional de Medicamentos (DNM). The commercial rule that matters for market access has not flipped: each sanitary registration names a single local legal representative, and whoever funds that filing usually controls the certificate.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial El Salvador file: how a medical device gets onto the Salvadoran market under the SRS / former-DNM pathway, why the local legal representative seat is a channel-design decision, and how that desk stays off the first-in-human critical path. It sits next to our LATAM market-access hub, the El Salvador DNM / SRS country page, and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

    One-sentence answer

    Commercial sale of a medical device in El Salvador requires sanitary registration administered by the Superintendencia de Regulación Sanitaria (SRS) — the successor, under the Ley de la Superintendencia de Regulación Sanitaria effective 7 August 2024, to the Dirección Nacional de Medicamentos (DNM) — with a single local legal representative named on each registration. A CNEIS / SRS clinical-trial authorization is not a license to sell.

    Two El Salvador desks — do not merge them

    Investigational use. Ethics and research authorization for first-in-human or other device studies (CNEIS / SRS research track). That file is not market clearance. See our El Salvador trial-versus-registro and FIH corridor pages.

    Commercial registro. Sale and distribution of a device that already has a clearance story elsewhere (often FDA or CE) follows the sanitary-registration pathway now under SRS. One local legal representative carries the regulatory obligations on that certificate. Registration ownership is not divisible across distributors.

    If your Gantt has one bar labeled “DNM,” update the label to SRS for new filings and keep trial and commercial on separate pages.

    What changed in August 2024 — and what did not

    Until August 2024, device registrations were administered by DNM. On 7 August 2024 the Ley de la Superintendencia de Regulación Sanitaria consolidated those competencies into SRS. For importer-of-record planning, the substantive pattern we still operate against is unchanged: one local legal representative per registration.

    What did change for operators is the agency name on letters, portals and invoices. Update your SOPs, power-of-attorney templates and distributor agreements so they do not still say “DNM only” when the file will land at SRS.

    Why who pays for the registration is the real design choice

    In El Salvador the local legal representative / importing entity sits on the certificate. If a distributor funds the filing, that distributor typically becomes the titleholder and can refuse a clean transfer when you change channel. We see that hostage pattern across single-representative Central American markets.

    Manufacturer-funded processing flips the control: the manufacturer pays for dossier, translations and agency liaison, keeps transfer-upon-demand language in the distribution agreement (reviewed by local counsel), and can move the title to a designee when the commercial relationship ends. That is a contracting and funding design, not a second sanitary petition.

    What belongs in the commercial dossier (operator list)

    Exact SRS forms move with agency practice. The working stack sponsors assemble before translators start is stable:

    • Device identity, intended use, and risk class as SRS will see it
    • Manufacturer and manufacturing sites, with quality-system evidence appropriate to class
    • Technical evidence already used for FDA or CE, mapped to the Salvadoran petition — not dumped as a zip of US folders
    • Labels and IFU in Spanish for the configuration you will sell
    • Local legal representative appointment and importing-entity documentation
    • A written funding and transfer plan: who pays, who is titleholder on paper, and how transfer-upon-demand is enforceable

    Electrical / EMC or RF homologation for wireless devices, when required, runs through El Salvador’s telecom authority as a separate vendor track. Do not bury that inside the sanitary clock.

    What this file is not

    • It is not a CNEIS / SRS clinical-trial authorization. Trial units and commercial units follow different petitions.
    • It is not a multi-importer registration. One local legal representative per certificate.
    • It is not an annual bioaccess® holder subscription in the same SKU as Mexico, Colombia or Costa Rica. On the live market-access offer, El Salvador is sold as manufacturer-funded registration processing because the local legal representative must be the importing entity — there is no separate annual holder fee to quote for that seat.

    How bioaccess® runs El Salvador registrations

    On the live market-access offer, bioaccess® processes El Salvador registrations funded by the manufacturer: dossier preparation, certified Spanish translations, agency liaison, and related tecnovigilancia support, while the distribution agreement (local counsel) keeps transfer-upon-demand control with the manufacturer. Government submission fees are set by the regulator. Scoped pricing is confirmed at proposal — we do not invent a statutory day-count or a flat holder subscription for El Salvador on this page. See bioaccessla.com/market-access/el-salvador-dnm and the market-access hub.

    Operator checklist before you open an El Salvador registro folder

    1. Write “trial” and “registro” on two pages. Put owners and the correct agency name (SRS) on each page.
    2. Decide who funds the filing and who sits as local legal representative before you pick a distributor.
    3. Put transfer-upon-demand language in the distribution agreement and have local counsel review it.
    4. Confirm the sellable configuration matches Spanish labels and IFU — not an investigational configuration.
    5. Budget RF / telecom tracks separately when the device is wireless.
    6. Update legacy “DNM” templates so new powers of attorney and invoices match SRS.

    Talk with bioaccess® when you need El Salvador registro processed without handing the certificate to the first distributor — or when you are sequencing an El Salvador FIH into a later commercial file without mixing the desks.

  • How to register a medical device in Costa Rica with MINSA (RTCR 505:2022)

    Sponsors still write “Costa Rica registration” as if the Ministerio de Salud ran one switch for trials and commercial sale. It does not. Equipo y Material Biomédico (EMB) gets onto the Costa Rican market under Reglamento Técnico RTCR 505:2022 through the Regístrelo portal. A CONIS / CEC clinical-trial file is not a license to sell.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page is the commercial Costa Rica file: how a medical device gets registered under RTCR 505:2022, when Class I is exempt, what a single Costa Rica Registration Holder (CRH) can and cannot do, and how that desk stays off the first-in-human critical path. It sits next to our LATAM market-access hub, the Costa Rica MoH country page, and the Importer of Record guide. Operator guidance only. Not a quote and not legal advice.

    One-sentence answer

    Commercial sale of Class 2, 3 and 4 EMB in Costa Rica requires sanitary registration with the Ministerio de Salud’s Dirección de Regulación de Productos de Interés Sanitario under Reglamento Técnico RTCR 505:2022 (“Equipo y Material Biomédico. Clasificación, Registro, Importación, Etiquetado, Publicidad, Vigilancia y Control”), filed online through Regístrelo under Decreto Ejecutivo N° 37988-S and Ley General de Salud N° 5395, with a single registered title holder (CRH) who may authorize downstream distributors on that registration. Class 1 EMB is exempt from sanitary registration under Decreto N° 41387-S, subject to labeling and control rules that still apply.

    Two Costa Rica desks — write them on separate pages

    Investigational use. Protocol review through an accredited CEC, CONIS registration, and the Ley 9234 research framework. That path is for first-in-human and other clinical research. It is not a commercial registro. See our Costa Rica FIH activation and CONIS coverage pages.

    Commercial registro. Manufacture, import, commercialization or distribution of EMB that already has a clearance story elsewhere (often FDA or CE) follows RTCR 505:2022. Risk class drives whether you file at all and what goes in the dossier. The named CRH is the regulatory face of the product.

    If your Gantt has one bar labeled “MINSA / MoH,” you do not have a plan. Trial units and commercial units are different petitions.

    What RTCR 505:2022 actually covers

    RTCR 505:2022 sets classification, registration, import, labeling, advertising, vigilance and control for EMB destined for human use in Costa Rica. It reaches products manufactured in-country, imports for commercialization or use, sale and distribution, advertising, labeling, and software / medical apps when they are EMB.

    Operator anchors we use when we open a Costa Rica folder:

    • Class 1: exempt from sanitary registration (Decreto N° 41387-S). Labeling and other control duties still apply — exemption is not “no rules.”
    • Class 2, 3 and 4: sanitary registration required before commercialization.
    • Filing channel: Regístrelo (www.registrelo.go.cr), with digital signature, under Decreto Ejecutivo N° 37988-S.
    • Foreign documents: apostilled or legalized, then notarially certified for Regístrelo upload; Spanish translation when the original is not in Spanish.
    • Validity: the Ministry’s public EMB page states a five-year sanitary registration term. Plan renewal before expiry; do not treat the certificate as perpetual.

    What the single CRH model means

    Costa Rica names one registered title holder on the sanitary registration. That CRH is the regulatory anchor. RTCR 505:2022 and the live Importer of Record guide confirm the CRH (or the product title holder / legal representative) can authorize third parties for importation or distribution when that authorization is indicated in the registration request — so multiple downstream distributors can sit under one registration without splitting titularidad.

    Design implication for US and European manufacturers: do not put the first commercial distributor on the certificate if you want a clean channel change later. Hold the CRH seat with an entity that answers to the manufacturer’s transfer doctrine, then authorize distributors underneath that holder.

    What belongs in the commercial dossier (operator list)

    Exact Regístrelo forms move with Ministry practice. The working stack sponsors assemble before translators start is stable:

    • Device identity, intended use, and RTCR risk class as the Ministry will see it
    • Manufacturer and manufacturing sites, with quality-system evidence appropriate to class (good-manufacturing / equivalent certificate for Class 2+, apostilled)
    • Free-sale / marketing-authorization evidence from a reference country when the class requires it
    • Technical and medical specifications, manuals and inserts for the configuration you will sell in Costa Rica — Spanish when the original is not
    • Clinical evidence of safety and performance for Class 3 (and higher-risk Class 4) filings, with Spanish translation when needed
    • CRH appointment / poder de representación with clear powers and term
    • Labels and IFU in Spanish matching the sellable configuration

    Electrical / EMC or RF homologation for wireless devices, when required, runs through Costa Rica’s telecom authority as a separate vendor track. Do not bury that inside the sanitary clock.

    What this file is not

    • It is not a CONIS / CEC clinical-trial authorization. Trial units enter under the research path; commercial units enter under RTCR 505:2022 registro.
    • It is not a Class 1 free-for-all. Exemption from registro still leaves labeling and control duties.
    • It is not a free pass to treat a Costa Rica FIH as proof of market clearance. First patient in and sanitary registration are different end states.

    How bioaccess® runs the Costa Rica holder seat

    On the live Costa Rica market-access page, bioaccess® acts as the Costa Rica Registration Holder (CRH) under its contract with you, working with our local partner in Costa Rica, for sanitary registration, importer-of-record duties where the CRH imports under the registration, and certified Spanish translations, with vigilance as holder. Costa Rica is quoted case by case and is not part of the published fixed-price plan (Mexico, Colombia, Brazil, Peru and Argentina); your quote states government fees, translations and holder service. Timelines are confirmed at proposal against the current Regístrelo / Ministry queue — we do not invent a statutory day-count here.

    Operator checklist before you open a Costa Rica registro folder

    1. Write “trial” and “registro” on two pages. Put owners and statutes on each page.
    2. Confirm class: Class 1 exempt vs Class 2/3/4 registro.
    3. Decide the CRH before you pick a distributor.
    4. Confirm the configuration you will sell matches the Spanish labels and IFU you will file — not the investigational configuration from an FIH.
    5. Budget apostille / legalization and digital-signature logistics into the Regístrelo calendar.
    6. Budget RF / telecom tracks separately when the device is wireless.

    Talk with bioaccess® when you need Costa Rica registro held independent of the commercial channel — or when you are sequencing a Costa Rica FIH into a later MoH market file without mixing the desks.

  • George Clinical / Emerald Clinical Device Trials vs a Latin America First-in-Human CRO (bioaccess®)

    If you typed George Clinical (Emerald Clinical) into a search box, you are probably building a CRO shortlist. This article uses only what George Clinical (Emerald Clinical) publishes (georgesclinical.com/therapeutic-expertise/medical-devices-cro · emeraldclinical.com · emeraldclinical.com/about-us) 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 George Clinical (Emerald Clinical) publishes

    George Clinical came out of The George Institute in Australia and in 2025 became Emerald Clinical Trials, which says it is headquartered in Singapore. George Clinical's medical device page covers feasibility, pilot, Class II/III pivotal and post-market studies, and describes it as a specialized CRO in Asia-Pacific and the USA. Emerald says it has completed 600+ trials across 70+ geographies over more than 25 years, with strength in renal, cardiovascular and oncology research.

    George Clinical (Emerald Clinical) vs bioaccess®

    Dimension George Clinical (Emerald Clinical) bioaccess®
    Core focus APAC-origin full-service CRO, late-phase strength First-in-human and early feasibility studies for medical devices
    Geography Australia 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 Post-market studies and surveillance, plus regulatory and pharmacovigilance services Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If the device program is a large pivotal or post-market study across Asia-Pacific, George / Emerald is a capable choice.

    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 on your list, including George Clinical (Emerald Clinical), 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.

    Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not George Clinical (Emerald Clinical) features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

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

    Competitor facts from the George Clinical (Emerald Clinical) public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Biointelect Australia vs a Latin America First-in-Human Device CRO (bioaccess®)

    If you typed Biointelect into a search box, you are probably building a CRO shortlist. This article uses only what Biointelect publishes (www.biointelect.com/cro) 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 Biointelect publishes

    Biointelect is a Sydney consultancy founded in 2011 that added a CRO. It lists medical devices among its therapeutic areas, plus first-in-human, Phase I–II and high-risk inpatient studies, and leans toward strategy, local sponsor and regulatory work. Leah Goodman is CEO.

    Biointelect vs bioaccess®

    Dimension Biointelect bioaccess®
    Core focus Australian consulting + CRO + local sponsor First-in-human and early feasibility studies for medical devices
    Geography Australia 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 Australian market entry support: legal local sponsor, TGA submissions, Resident Director services and R&D Tax Incentive coordination Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If what you need is an Australian entity, local sponsor and R&D tax-incentive coordination around a Phase I unit, Biointelect fits.

    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 on your list, including Biointelect, 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.

    Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Biointelect features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

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

    Competitor facts from the Biointelect public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.

  • Datapharm Australia vs a Latin America First-in-Human Device CRO (bioaccess®)

    If you typed Datapharm Australia into a search box, you are probably building a CRO shortlist. This article uses only what Datapharm Australia publishes (datapharmaustralia.com) 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 Datapharm Australia publishes

    Datapharm Australia, in Drummoyne, Sydney, calls itself Australia's original full-service CRO, founded in 1987. Its therapeutic list includes devices, diagnostics and first-in-humans, and its cardiovascular page cites implants and stents. Helen Allars and John Edington are its co-founders.

    Datapharm Australia vs bioaccess®

    Dimension Datapharm Australia bioaccess®
    Core focus Mid-market single-country Australian CRO, drug and device First-in-human and early feasibility studies for medical devices
    Geography Australia 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 Phase IV post-marketing and observational studies, and pharmacovigilance services Live multi-country sanitary registration and in-country holder service

    Where each one fits

    If you need a single-country Australian device or first-in-human study with a long-established local CRO, Datapharm fits.

    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 on your list, including Datapharm Australia, 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.

    Australia sells real country features: the CTN scheme, English-language ethics and, for eligible companies, the R&D tax incentive. Those are country features, not Datapharm Australia features. The country math is on bioaccess® vs Australia, and the established Australian device EFS boutique is covered in Mobius Medical vs bioaccess®.

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

    Competitor facts from the Datapharm Australia public pages linked above and public announcements, reviewed for bioaccess® competitive research (Aug 2026–Nov 2026). Claims are theirs. No invented sponsors, prices or contacts.