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Author: Julio Martinez-Clark

  • 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.

  • Foreign proctors and field engineers at first-in-human cases in Latin America: who needs a permit

    A few weeks before the first case, a sponsor almost always asks me the same thing: our implanting physician from the US wants to proctor the first cases, and our field clinical engineer will be in the room. Do they need anything from the local authorities? The answer is yes for the physician in most of Latin America. For the engineer it depends on what he or she touches.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page sets out what the public rules say in Colombia, Brazil and Panama about foreign physicians taking part in procedures, how that interacts with 21 CFR Part 812, and how I plan the paperwork so the first case doesn’t slip. It sits next to our early feasibility studies page, the Panama FIH guide and the clinical trial insurance guide. This is operator guidance, not legal advice. Confirm the current requirements with the site and the local medical college before you book flights.

    One-sentence answer

    A foreign physician who performs or scrubs into a procedure in a Latin American trial needs a temporary authorization from the local medical regulator, requested by the host institution, with home-country licenses, a named local team that stays responsible for the patient, and in Colombia a liability policy and a declared purpose that is not promotional. A sponsor engineer who stays off the sterile field and never handles the device while it is in the patient is usually treated as technical support, not as practicing medicine.

    Why this is a regulatory question, not a travel question

    Medicine is a licensed profession in every country in the region. A business visa lets someone enter the country. It does not let them operate. When a foreign physician treats a study subject without the local authorization, the problem lands on the site, on the investigator who allowed it and on the data. An ethics committee or a monitor who finds an unlicensed operator in the procedure notes will ask questions you don’t want in an FDA submission.

    Colombia: permiso transitorio

    Colombia has the most detailed public framework I know of in the region.

    • Legal basis. Ley 1164 de 2007, Art. 18, parágrafo 3, grants foreign health personnel who come in scientific missions or to provide services of a humanitarian, social or research character a temporary permit for the length of the mission, which must not exceed six months. Extensions are only for exceptional, documented cases. Parágrafo 3 says the permit is issued by the Ministry of Health directly or through the professional colleges with delegated public functions, and Art. 10(c) lists issuing it among those colleges’ functions.
    • Procedure. Decreto 780 de 2016, Arts. 2.7.2.1.3.1 to 2.7.2.1.3.3 (which took over Arts. 21 to 23 of Decreto 4192 de 2010), set out the request. The Ministry’s Circular Externa 024 of 6 July 2018 explains how the colleges apply it. A denial by a college can be appealed to the Ministry.
    • The commercial exclusion. Circular 024 says no permit will be granted when the purpose, the activities or one of the objectives of the mission is the promotion, advertising, sponsorship or commercialization of services, procedures, medicines, devices or health technologies. A clinical investigation is research, but write the request so that the purpose is plainly the protocol, not training for a commercial launch.
    • Payment. The circular says paying the foreign professional’s fees or expenses does not by itself make the mission for-profit. If a Colombian institution pays the visiting physician, the request has to say so and explain why personnel licensed in Colombia were not used. No payment may come from the patients.
    • Host IPS. The mission must be supported by a health provider (IPS). The request names the IPS and the services used, with a letter from its legal representative accepting responsibility for the consequences for patients. The college checks those services are enabled in the REPS registry.
    • Insurance. Once the permit is granted, the responsible organization must take out a collective civil liability policy of no less than 250 monthly minimum wages, covering the mission plus 12 months, with an insurer supervised by the Superintendencia Financiera. The territorial health authority asks for it before the mission starts. This is separate from the study’s clinical trial insurance.

    Brazil: autorização especial from the CRM

    In Brazil the route runs through the regional medical council (CRM) under Resolução CFM nº 1.494/1998, which covers medical acts performed as didactic demonstrations by foreign physicians invited by universities, official bodies, associations and scientific institutions. Art. 1 asks the inviting institution to give the CRM:

    • the names of the invited medical team;
    • proof that they entered Brazil lawfully;
    • original documents from their home countries proving they are licensed;
    • a program, approved by the sponsoring institution, with the place of the procedures, proof of technical capacity, the local medical team and each member’s level of responsibility, patient selection criteria without discrimination, the immediate and late post-operative plan including complications, the patient’s informed consent and a favorable opinion from the institution’s medical ethics committee.

    Art. 2 makes the institution’s technical director responsible for compliance. Art. 3 forbids charging any payment for the medical acts performed. The CFM’s service page asks for the request at least 30 days in advance, with a responsibility statement signed by the institution’s technical director. I plan for that 30-day window as a minimum, on top of the CEP and ANVISA approvals the trial already needs.

    Panama: reserved profession, case-by-case authorization

    MINSA states publicly that medicine in Panama is a profession reserved for nationals. Ley 69 de 2013 lets MINSA and the Caja de Seguro Social hire foreign health professionals temporarily, but it is a public-sector hiring route with exams and a temporary registry. It is not designed for a visiting proctor.

    For a visiting physician, Panama’s procedure guides list a MINSA procedure, handled by the Dirección General de Salud, that authorizes foreign physicians to take part in demonstrations and surgical procedures together with Panamanian physicians in public and private hospitals. The request is a formal letter from the hospital or medical association, with the invited physicians’ licenses and certificates of good standing. Read the word “together”: the Panamanian investigator stays in the case.

    Other countries

    Each country has its own route, usually through the medical college or the health ministry, and the requirements change. Don’t assume a rule from one country carries over to the next. Ask the site’s medical director early which authority grants the permit, who files it and how long it takes. If nobody at the site has done it before, that is a feasibility finding.

    Where 21 CFR Part 812 fits

    • Who is an investigator. 21 CFR 812.3(i) defines the investigator as the person under whose immediate direction the device is used on a subject. A proctor who performs part of the procedure is doing investigator work. List the proctor on the site’s delegation log with the tasks delegated, and make sure the local principal investigator stays responsible.
    • Qualified investigators. 812.43(a) requires the sponsor to select investigators qualified by training and experience. The local authorization is part of the evidence that the person was qualified to act in that country.
    • Data you want FDA to accept. If the study will support an IDE or a marketing submission, 812.28(b) asks for the names and qualifications of the investigators. A case run by someone without local authorization is a weak point in that file.
    • No promotion. 812.7(a) prohibits promoting an investigational device. It lines up with Colombia’s commercial exclusion. Keep proctoring framed as protocol support.

    Field clinical engineers

    Engineers set up consoles, check software versions, confirm device sizes and answer technical questions. That is normal in early feasibility work. Here is the line I hold:

    • Off the sterile field, no hands on the patient and no hands on the device while it is in the patient.
    • Name the role in the protocol or the monitoring plan, and the tasks on the delegation log.
    • Hospital access, confidentiality and any badge or induction the hospital requires are agreed with the site before the visit.
    • If the engineer has to do more than that, treat it as a clinical role and run it through the authorization route above, or train a local team member to do it.

    Mistakes I see

    • Booking the first case before the permit is granted, then pushing the date when the college asks for an apostilled document.
    • A request that reads like a product launch or a training tour, which in Colombia is a reason to refuse it.
    • No local physician named as responsible for post-operative care and complications.
    • Assuming the clinical trial insurance policy covers the foreign physician. In Colombia the mission needs its own civil liability policy.
    • No delegation-log entry for the proctor, which shows up at the first monitoring visit.

    How bioaccess® runs this

    bioaccess® plans the proctor and engineer plan during site selection, works with the site’s medical director to prepare the authorization request, collects and apostilles the licenses and certificates, and lines up the permit date with ethics and regulatory approvals and device import. Study scope and pricing are set at proposal. Start on our early feasibility studies page, see market access for the country pages, or book a call.

    Operator checklist

    1. At feasibility, ask the site which authority grants the visiting-physician permit and how long it takes.
    2. Collect home-country licenses, certificates of good standing and diplomas, apostilled, at least 6 weeks before the first case.
    3. Write the request around the protocol: purpose, dates, procedures, patients, local team.
    4. Colombia: name the IPS, get its legal representative’s letter, declare any payment and buy the 250-minimum-wage liability policy for the mission plus 12 months.
    5. Brazil: file with the CRM at least 30 days ahead with the CFM 1.494/1998 program and the ethics committee opinion.
    6. Panama: the hospital files the MINSA request; the Panamanian investigator stays in the case.
    7. Put the proctor and the engineer on the delegation log with defined tasks.
    8. Keep the permit in the investigator site file, ready for monitoring and for an FDA 812.28 package.

  • 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.

  • INMETRO certification and ANATEL homologation for medical devices in Brazil (RDC 549/2021, IN 283/2024)

    When a manufacturer brings me an FDA-cleared or CE-marked powered device for Brazil, the timeline conversation usually starts with ANVISA. It should start one step earlier. For electromedical equipment, ANVISA won’t grant, change or revalidate the registration without a Brazilian conformity certificate, and a device with a radio inside needs a separate ANATEL homologation before it can be sold. Neither is replaced by your CB report, your 510(k) or your CE certificate.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page explains the two certifications that sit in front of many ANVISA device files: compulsory conformity certification under RDC 549/2021, usually called “INMETRO certification”, and ANATEL homologation under Resolução 715/2019. It sits alongside our Brazil ANVISA registration page, the Brazil registration holder guide and the LATAM market-access hub. This is operator guidance, not legal advice.

    One-sentence answer

    Under ANVISA RDC 549 of 30 August 2021, medical, dental, laboratory, physiotherapy and aesthetic equipment must carry a conformity certificate issued within the Brazilian conformity assessment system (SBAC) by an Inmetro-accredited certification body established in Brazil, against the standards listed in ANVISA IN 283/2024, and the supplier must present it to grant, change or revalidate the ANVISA registration or notification. Any telecom function needs ANATEL homologation, which Resolução 715/2019 Art. 55 makes a mandatory prerequisite for use and sale in Brazil.

    Which devices need the conformity certificate

    RDC 549/2021 (in force since 1 October 2021) covers “equipment under health surveillance”, including parts and accessories. Article 2 §2 defines two groups:

    • equipment with a medical, dental, laboratory or physiotherapy purpose, used directly or indirectly for diagnosis, treatment, rehabilitation or monitoring in humans;
    • equipment for beautification and aesthetics.

    The test is whether the product is equipment within the field of application of a listed standard, not its risk class. Article 3 applies to both registration (registro) and notification files. So a Class II notified device can need the certificate just as a Class III registered one does. Article 2 §3 also says the certificate isn’t the only proof of safety and efficacy, and ANVISA can still ask for more studies.

    Which standards apply: IN 283/2024

    RDC 549 points to a list of technical standards set by ANVISA instruction. The current list is Instrução Normativa 283 of 7 March 2024, in force from 1 April 2024, which revoked IN 116/2021. Annex I lists the ABNT NBR IEC 60601 family: the general standard 60601-1, collaterals such as 60601-1-2 (electromagnetic disturbances), 60601-1-6 (usability) and 60601-1-8 (alarm systems), and the particular standards for specific equipment types.

    Annex II sets a transition worth putting on your calendar. ABNT NBR IEC 60601-1:2010 with Amendment 1:2016 is the version currently enforced. The version with Amendment 2:2022 becomes compulsory on 31 December 2027, and 60601-1-2 with Amendment 1:2022 follows the same date. If your test reports predate Amendment 2, ask your certification body now whether a renewal or change filing after that date will need new testing.

    Two other IN 283 provisions help in practice. Article 2: when no accredited Brazilian lab can run part of a standard, the certification body justifies the gap and lists the exclusions on the certificate. Article 3: if ANVISA asks you to add a standard that you believe doesn’t apply, you answer with a technical justification, which you may have a certification body issue.

    Who issues the certificate

    Inmetro’s FAQ (updated 7 April 2026) states that the certification is performed by a product certification body (OCP) established in Brazil and accredited by Inmetro, under Portaria Inmetro 384 of 18 December 2020 as amended by Portaria 254 of 9 June 2021. That portaria sets the conformity assessment requirements and the identification seal. Two details in the portaria are worth knowing:

    • Article 2 says Inmetro doesn’t regulate these products technically. ANVISA sets the requirements; Inmetro accredits the bodies that check them.
    • Article 6-A lets the certificate expire early if the certification body or ANVISA finds the manufacturer changed the design in a way that critically affects safety.

    The OCP runs the evaluation its certification scheme sets out. Pick it early and agree with it which of your existing reports it can accept.

    What the certificate does in the ANVISA file

    • Grant, change and revalidation (RDC 549 Art. 3). The supplier presents a copy of the certificate. Changes that count are those that affect the standards used in the certification, and the certification body that issued the certificate assesses that impact.
    • A shortcut for imports (Art. 3 §1). An importer filing a certified imported device is exempt from presenting the certificate of free sale or origin-country registration. That is useful for devices whose home approval is still pending, a problem I covered in the certificate of free sale trap.
    • Summary rejection (RDC 751/2022 Art. 10 §4). Under ANVISA’s device registration rule, a petition missing a required conformity certificate isn’t sent a deficiency letter; it can be refused outright.
    • Suspension (RDC 751/2022 Art. 39). ANVISA can suspend manufacture, import, distribution, sale and use when a compulsory conformity certificate is missing.

    When certification isn’t possible

    RDC 549 Article 4 covers equipment that can’t be certified in the SBAC at the time of filing. The applicant presents a declaration from an Inmetro-accredited certification body explaining why. Once capacity exists, the holder has 180 days to present the certificate, and missing that window starts suspension and cancellation. Where the problem is partial and temporary, the file instead carries a consolidated report from an OCP, in Portuguese and showing conformity on every item checked. For equipment tested abroad, the OCP can build that report on test reports from labs accredited by ILAC signatories, as long as they cover at least the items that can be tested in Brazil.

    Keeping it valid

    Article 7 makes the certificate a condition for keeping the registration. If it is canceled or expires during the registration’s life, you have 90 days to present a new one; past that, suspension and cancellation procedures start. The 90 days don’t apply if the certificate was pulled because the product failed the standards. Put certificate expiry and surveillance audits in the same tracker as the ANVISA revalidation.

    ANATEL: the radio is a separate product

    If the device has Bluetooth, Wi-Fi, cellular or another radio, a second regime applies. ANATEL’s Resolução 715 of 23 October 2019 defines a telecommunications product as equipment, apparatus, device or element that is necessary or sufficient to carry out telecommunications, including accessories and peripherals (Art. 4, XVI). Article 55 makes homologation a mandatory prerequisite for using and selling such products in Brazil. Since Resolução 780 of 1 August 2025, Article 55 §1 also lets ANATEL require homologation before import in cases it defines by operational procedure.

    The certificate comes from a designated certification body that the applicant chooses (Art. 40), and the applicant has to show it can meet Brazilian consumer guarantees, including product information, warranty and technical assistance (Art. 21). ANATEL homologation and the RDC 549 certificate are separate procedures under separate agencies. Plan both, and decide early which Brazilian company applies for each one.

    How bioaccess® handles it

    bioaccess® acts as your Brazil Registration Holder under contract with you, working with our local partner in Brazil, and files the ANVISA dossier. Before filing, we map which IN 283 standards apply, collect your existing test reports, coordinate the Brazilian OCP and any ANATEL designated certification body, and line up the certificates with the registration timeline. As the Brazil page states, INMETRO and ANATEL work is not included in the registration and holder fees and is quoted separately, as is Brazil GMP. Brazil pricing is two-part: a one-time registration fee plus an annual holder fee. If you are planning a clinical study rather than a launch, start with clinical trials in Brazil.

    Operator checklist

    1. Check whether your device is equipment within the field of a standard in IN 283/2024 Annex I, whatever its risk class.
    2. Choose an Inmetro-accredited OCP established in Brazil and agree which existing reports it accepts.
    3. Check your 60601-1 and 60601-1-2 reports against the 31 December 2027 Annex II date.
    4. If certification isn’t possible, get the Article 4 OCP declaration and track the 180-day clock.
    5. Identify every radio function and plan ANATEL homologation before import and sale.
    6. Track certificate expiry with the 90-day replacement window in Article 7.
    7. Have the certification body assess design changes before you file a registration change.

  • Stopping rules, staggered enrollment and safety oversight in a first-in-human device study

    The protocol question I get most from first-in-human device teams isn’t about endpoints. It’s this: after the first patient, what has to happen before we treat the second one? Ethics committees in Latin America ask the same thing, usually in the first review letter. If the protocol answers it with “per investigator judgment”, expect a query.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page sets out how I write stopping rules, staggered enrollment and safety oversight into a first-in-human (FIH) or early feasibility device protocol, using what the FDA guidance, 21 CFR Part 812 and Brazil’s ANVISA RDC 837/2023 actually say. It sits next to our early feasibility studies page, the FIH protocol template and the FIH basics article. This is operator guidance, not legal advice.

    One-sentence answer

    A defensible FIH device protocol enrolls a small sentinel group one subject at a time, names the event types that pause enrollment, gives a named reviewer (a medical monitor, safety committee or data monitoring committee) the decision to resume, and maps every pause to the reporting clocks of each regulator involved: 10 working days for unanticipated adverse device effects under 21 CFR 812.150, and 24 hours from investigator to sponsor plus 7 or 15 calendar days to ANVISA under RDC 837/2023.

    What FDA’s early feasibility guidance says

    FDA’s guidance on investigational device exemptions for early feasibility studies, issued 1 October 2013, is still the clearest public text on this. Section 7.1 lists risk-mitigation measures FDA expects to see weighed against the uncertainty of an early device. The list reads like a protocol checklist:

    • sites with the expertise to manage the adverse events you anticipate;
    • investigators who are qualified and trained on the device;
    • limiting the number of subjects, with 5 to 10 initial subjects given as an example;
    • more frequent follow-up than standard care;
    • timely reporting of serious adverse events, after each occurrence;
    • non-sequential enrollment, for example treating patients with more favorable anatomy first;
    • a pre-specified plan for assessing outcomes before enrolling more patients, which can be as frequent as after each use.

    Section 7.3.2 adds the IRB side. Reviewing boards may look at an early study more often than once a year, review after a small target number of subjects, or use graduated enrollment based on a safety analysis of the preceding subjects. Section 7.4.2 says a data monitoring committee of clinicians, scientific experts and people with ethics expertise can serve as a risk-mitigation element. The guidance’s Appendix 4 example describes up to 10 subjects at up to 3 sites, with each subject evaluated before the next is enrolled.

    None of that is binding, and FDA says so. But when a US reviewer later looks at your Latin American FIH data, this is the yardstick in their head.

    The binding clocks in 21 CFR Part 812

    If the study runs under an IDE, or you want the data to support a US submission, three provisions shape the stopping rule:

    • Definition (812.3(s)). An unanticipated adverse device effect (UADE) is a serious effect on health or safety, a life-threatening problem or a death caused by or associated with the device, if it wasn’t identified in nature, severity or incidence in the investigational plan, or any other unanticipated serious problem tied to the device that relates to subjects’ rights, safety or welfare.
    • Reporting (812.150). The investigator reports a UADE to the sponsor and the reviewing IRB as soon as possible and no later than 10 working days after first learning of it. The sponsor reports the results of its evaluation to FDA, all reviewing IRBs and participating investigators within 10 working days after first receiving notice.
    • Evaluation and termination (812.46(b) and (c)). The sponsor evaluates a UADE immediately. If it presents an unreasonable risk to subjects, the sponsor terminates all investigations, or the parts that carry the risk, as soon as possible and no later than 5 working days after making that determination and no later than 15 working days after first receiving notice. For a significant-risk device, resuming needs IRB and FDA approval.

    For studies outside the United States, 21 CFR 812.28 lets FDA accept the data if the investigation is well designed, well conducted and follows good clinical practice, including independent ethics committee review. Writing the stopping logic to the Part 812 standard costs nothing at the protocol stage and removes an argument later.

    What Brazil adds under RDC 837/2023

    ANVISA’s RDC 837 of 13 December 2023 governs device clinical investigations in Brazil. It is more specific than most sponsors expect:

    • Data monitoring committee (Art. 57). Before the study starts, the sponsor considers a DMC based on its risk analysis of the device and of study participation. Pivotal studies of Class III and IV devices must have one, and its recommendations go to ANVISA as an amendment (aditamento) within 30 calendar days. The DMC’s functions belong in the clinical investigation plan, and if you decide not to set one up, the plan has to justify that.
    • Aggregate review (Art. 54). The sponsor, or an independent DMC, evaluates adverse events in aggregate, and that evaluation feeds the annual reports.
    • Investigator to sponsor (Art. 62). Serious adverse events and deaths reach the sponsor within 24 hours.
    • Sponsor to ANVISA (Arts. 63 and 64). Unexpected serious events in Brazil that are fatal or life-threatening, with possible, probable or definite causality to the device, go to ANVISA within 7 calendar days of the sponsor learning of them, with follow-up information added within 8 calendar days. All other unexpected serious events with that causality go within 15 calendar days.
    • Pauses (Arts. 24 and 26). A temporary suspension taken as an immediate safety measure is notified within 7 calendar days. A sponsor decision to suspend or cancel the study, with its justification and follow-up plan for enrolled subjects, is notified within 15 calendar days.
    • Restart (Art. 27). Reactivating a suspended study is a secondary petition to ANVISA, and the study restarts only after ANVISA approval is published in the Diário Oficial da União.

    ANVISA’s adverse-event manual for device trials (2nd edition, 13 November 2024) explains the NotivisaEC form and uses the WHO-UMC causality categories. Use the same categories in your protocol so the investigator’s causality call maps straight onto the form. For the wider submission picture, see our ANVISA device clinical trial submission guide. If your sites are in Argentina, the clocks differ; see adverse event reporting to ANMAT in FIH trials.

    How I write the stopping rule

    A stopping rule that works has five parts. I write each one as a sentence the site coordinator can follow at 2 a.m.

    1. Sentinel cohort. Name the number of subjects treated one at a time. Use the guidance’s 5-to-10 range as a reference, not a target. The right number depends on how fast the device’s failure modes show up.
    2. Observation window. State how long each sentinel subject is followed before the next is treated, and why. The window comes from the device’s mechanism and the acute risk profile in your risk analysis, not from a template.
    3. Pause triggers. List them as event types, not judgment calls. Any UADE, any device-related death, any unexpected serious device effect, and any device malfunction that could have caused serious harm. Add device-specific triggers from the risk file, such as migration, embolization or loss of function.
    4. Who decides. Name the reviewer and say what they see. For a small single-country FIH study, an independent medical monitor or safety committee may be enough. Where Art. 57 applies, or the risk analysis points to it, a DMC with a written charter. Investigators and sponsor employees don’t vote on their own restart.
    5. Restart conditions. Say what evidence ends the pause: root-cause analysis, a protocol or IFU change if needed, ethics committee notification and, where a regulator requires it, agency approval before the next subject. In Brazil that means the Art. 27 reactivation petition.

    Non-sequential enrollment is a design choice

    The guidance’s suggestion to treat favorable anatomy first is easy to miss. In practice it means the first subjects are the ones in whom a failure is most likely to be the device’s fault, not the patient’s. Write the sentinel-cohort inclusion criteria tighter than the expansion cohort, and say so in the protocol. Committees read that as a sponsor thinking about subject safety, and it makes the first safety review easier to interpret.

    Common mistakes I see

    • Stopping rules written as “the sponsor may pause enrollment” with no triggers.
    • A DMC charter that exists on paper but meets only after the last subject.
    • Causality scales in the protocol that don’t match the regulator’s form.
    • One reporting clock in the protocol when the study runs in two countries with different clocks.
    • No plan for subjects already treated when the study pauses, which RDC 837 Art. 24 asks for.

    How bioaccess® runs this

    bioaccess® designs the safety-oversight section with the sponsor’s medical and clinical team: sentinel cohort, pause triggers, the reviewer and its charter, and a single reporting matrix that covers every country in the study. We set up independent safety reviewers, run the investigator-to-sponsor-to-agency chain and file pause and restart notices with ethics committees and regulators. Study scope and pricing are set at proposal. Start on our early feasibility studies page or clinical trials in Brazil, or book a call.

    Operator checklist

    1. Write the sentinel cohort size and the observation window, with the reason for each.
    2. List pause triggers as event types drawn from 812.3(s) and your risk file.
    3. Name the reviewer who decides restarts and what data they see.
    4. Decide on a DMC against RDC 837 Art. 57, and justify it in the plan if you don’t set one up.
    5. Build one reporting matrix: 24 hours site to sponsor, 7 and 15 calendar days to ANVISA, 10 working days under 812.150.
    6. Use WHO-UMC causality categories so site calls map onto NotivisaEC.
    7. Write the follow-up plan for treated subjects before you need it.

  • Medexa Ecuador Registration Holder vs bioaccess® LATAM Market Access

    Medexa is a Quito-based regulatory affairs firm that publishes a “Representación Legal y Holding Regulatorio” service for foreign manufacturers that want to register products in Ecuador without setting up a local company. The service page is at medexapro.com/representacion-legal-y-holding-regulatorio (retrieved 20 October 2026). This article uses only what Medexa publishes, then compares it with the multi-country market access offer from bioaccess®.

    What Medexa publishes

    Medexa says it acts as titular regulatorio in Ecuador for foreign manufacturers with no local structure, “especialmente en dispositivos médicos.” The holding page lists two parts:

    • Representación regulatoria: formal action before ARCSA, Agrocalidad and other authorities; acting as the local solicitante for registros sanitarios and notificaciones sanitarias; coordination with manufacturers, distributors and logistics operators; follow-up of requirements, renewals and post-registration processes.
    • Holding regulatorio: regulatory titularity independent of the commercial distributor, continuity if the importer or commercial strategy changes, and central management of a portfolio of Ecuadorian registrations.

    Its FAQ says a foreign manufacturer does not necessarily need an Ecuadorian company, that who keeps the titularity “depends on the regulatory strategy,” and that the structure can be migrated by a regulated transfer if the manufacturer later opens its own subsidiary. Medexa also covers pharmaceuticals, cosmetics, foods and supplements, and veterinary and aquaculture products, plus BPM/HACCP/ISO systems and trademark registration before SENADI. We found no public price on the site.

    The pitch fits Ecuador. As summarized in the bioaccess® LATAM registration guide, an Ecuadorian registration must be held by a local Ecuadorian company, a single holder, under Resolución ARCSA-DE-026-2016-YMIH (as reformed), which Resolución ARCSA-DE-2026-003-DASP will replace when it takes effect on 28 January 2027. A titular that is not your distributor lets you change or add importers without losing the registro.

    Medexa vs bioaccess®

    Dimension Medexa (Ecuador) bioaccess®
    Public product Local representation and regulatory holding before ARCSA, plus dossiers, quality systems and trademarks 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 Ecuador 19 Latin American and Caribbean markets, including Ecuador (ARCSA)
    Product mix Devices, pharmaceuticals, cosmetics, foods, veterinary and aquaculture products 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); Ecuador 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 Ecuador is the only market on the plan and a local titular separate from your distributor is the whole job, Medexa’s published offer covers it, and it says the right things about keeping the registration independent of the seller.

    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 (in Colombia, as your attorney-in-fact), importer of record where applicable, and tecnovigilancia contact. Ecuador and the other covered markets are quoted case by case.

    One country and a local titular 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.

  • Apostille or consular legalization for medical device registration in Latin America

    Sponsors budget months for the technical file and then lose weeks on a stamp. Almost every Latin American device regulator wants foreign documents (the certificate of free sale, the manufacturer’s power of attorney, the CE or quality-system certificate) authenticated before it will read them. Whether that means an apostille or a trip through a consulate is a question you can answer in an afternoon, if you know where to look.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page explains how the 1961 Hague Apostille Convention applies to medical device registration across Latin America, and what each regulator’s own rule adds on top. It sits alongside our LATAM market-access hub and the country registration guides linked below. This is operator guidance, not legal advice.

    One-sentence answer

    All 19 countries this guide covers (Mexico, Central America including Belize, the Dominican Republic, and South America from Colombia and Venezuela to Argentina and Chile) are Contracting Parties to the Hague Convention Abolishing the Requirement of Legalisation for Foreign Public Documents (HCCH status table, last updated 30 June 2026). For a public document issued in another Contracting State, including the United States, EU member states, China (in force 7 November 2023) and Canada (in force 11 January 2024), a single apostille from the issuing country replaces consular legalization. The destination regulator’s own rule still decides which documents need it and in what language.

    What the Convention actually does

    • It replaces legalization, not translation (Articles 2 and 3). Legalization means the destination country’s diplomatic or consular agent certifying the signature, the signer’s capacity and the seal. Between Contracting States, the only formality that may be required is the apostille, issued by the competent authority of the State where the document comes from.
    • It certifies the signature, not the content (Article 5). An apostille confirms who signed and in what capacity. It says nothing about whether your device is safe or your certificate is current.
    • It covers public documents (Article 1). These are court documents, administrative documents, notarial acts, and official certificates placed on private documents, such as a notary’s certification of a signature. It does not cover documents executed by diplomatic or consular agents, or administrative documents dealing directly with commercial or customs operations.
    • Each State names its own issuing authorities (Article 6). The HCCH publishes the list for every Contracting Party.

    The practical consequence: a certificate issued by a health authority is an administrative document and can be apostilled directly. A manufacturer’s letter of authorization, power of attorney or sworn declaration is a private document. It has to be notarized first, and the apostille goes on the notarial certificate. Certificates from private certification bodies follow the same notarize-then-apostille route unless the destination regulator says otherwise.

    Check the objection column before you rely on it

    Article 12 says an accession only takes effect between the acceding State and the Contracting States that did not object within six months. The HCCH status table flags these cases. For example, China’s accession drew an objection from India, so the Convention does not run between those two, while it does run between China and the Latin American parties. China also declared that the Convention does not apply between China and Contracting States it does not recognize as sovereign. If you are filing a Chinese document in a country without diplomatic relations with Beijing, confirm acceptance with the regulator before you rely on the apostille.

    This matters more than it used to. We regularly get registration requests from manufacturers in mainland China. Before November 2023, their certificates had to go through consular legalization. Today the apostille route is open for most Latin American destinations.

    What the regulators ask for

    The Convention removes the consulate step. It doesn’t change the regulator’s checklist. Here is what the device rules we have read in primary text say.

    Colombia (INVIMA)

    Article 44 of Decreto 4725 de 2005: foreign documents that correspond to official information must be authenticated by the Colombian consul and the Ministry of Foreign Affairs or, where applicable, carry an apostille. Documents not in Spanish need an official translation. If a document states no validity, it’s treated as valid for one year. That one-year default catches teams who apostille a certificate of free sale early and then wait on the rest of the file. See our INVIMA registration guide.

    Nicaragua (MINSA/ANRS)

    NTON 24001:2023 requires the local legal representative’s power from the manufacturer to be apostilled or, failing that, consularized and legalized. The FDA certificate (for US-made products) or the certificate from the authority of the country of manufacture must be in original or a notarized copy, in Spanish or with a notarized translation, and apostilled or consularized and legalized. The same applies to CE certificates for EU manufacturers. A certificate of conformity with no verification mechanism must also be apostilled or consularized. See our Nicaragua guide.

    Honduras (ARSA)

    Acuerdo 0631-ARSA-2023 repeats the same instruction across its requirement lists. A document issued abroad must be apostilled or authenticated. If the registrant is a Honduran company, the document is presented as a photocopy with its certificate of authenticity. See our Honduras guide.

    Paraguay (DINAVISA)

    Resolución DINAVISA 226/2024: every foreign legal document must be consularized and legalized, or apostilled, and translated into Spanish by a public translator registered with Paraguay’s Supreme Court. DINAVISA’s filing instructions add that each document goes in with its translation and apostille or legalization stamps in a single file. The contractual relationship between manufacturer and marketer also has to be apostilled or consularized. See our Paraguay guide.

    Bolivia (AGEMED)

    AGEMED’s device manual asks for the certificate of free sale to be legalized by the Bolivian consulate, or certified by Bolivia’s Ministry of Foreign Affairs where there is no consulate. The quality-system certificate needs a copy legalized by the health authority, not necessarily consularized, and the legal-representation document doesn’t need consularization. The manual predates Bolivia’s accession to the Convention (in force 7 May 2018), so confirm with AGEMED how its evaluators apply the apostille. See our Bolivia guide.

    For the larger markets (ANVISA, COFEPRIS, ANMAT and the others in our hub), check the current agency instruction for each document type before you send anything for apostille. Rules on which documents need it, and whether a sworn translation must follow, differ by document.

    The order of operations

    1. List every foreign document the destination rule names: certificate of free sale or FDA certificate, power of attorney or letter of authorization, CE or quality-system certificate, manufacturing contracts, declarations.
    2. Sort them into public and private. Health-authority certificates are public. Manufacturer letters and declarations are private and need a notary first.
    3. Get the apostille in the issuing country, from the authority that country designated under Article 6. A document notarized in one country can’t be apostilled in another.
    4. Translate in the destination country when the rule requires an official or sworn translator, as Colombia, Nicaragua and Paraguay do. Have the translator cover the apostille as well.
    5. Track validity from the issue date. Colombia defaults to one year, and Paraguay and Bolivia accept a certificate that states no validity for two years. Schedule apostilles so the documents are still valid when the agency reviews them, not just when you file.
    6. Use consular legalization only when the Convention doesn’t apply: when the issuing country isn’t a Contracting Party, an objection blocks the pair, or the document falls outside Article 1.

    Where this fits in a registration

    Legalization is rarely why a registration fails, but it’s often why one starts late. A missing apostille on a power of attorney means an observation and a correction round in Paraguay, and an expired certificate of free sale in Colombia means a new round trip to the issuing country. Build the legalization plan in the first week, at the same time as the technical file. Our certificate of free sale post covers the earlier problem: devices that don’t yet have a home-country authorization to certify.

    How bioaccess® handles it

    Every registration bioaccess® processes starts with a document map: which foreign documents the destination rule names, which need a notary, where each apostille comes from, and which translator signs the Spanish version. The bioaccess® fixed-price market-access subscription covers only multi-importer countries plus Argentina. Other countries are quoted as scoped, manufacturer-funded processing. Details: bioaccessla.com/market-access.

    Operator checklist

    1. Confirm on the HCCH status table that both the issuing and destination countries are parties, and check for objections.
    2. Notarize private documents before you send them for apostille.
    3. Apostille in the country where the document was issued or notarized.
    4. Book sworn or official translators in the destination country early.
    5. Calendar validity: one year by default in Colombia, two years in Paraguay and Bolivia.
    6. Keep the original apostilled documents. Several regulators want originals or notarized copies, not scans.

  • How to register a medical device in Bolivia with AGEMED (Ley 1737 and the device manual)

    When a manufacturer asks me about Bolivia, the first surprise is how old the rulebook is. AGEMED still runs device registration on a manual written when the regulator was called DINAMED, and Bolivia’s official procedures portal cites that manual today as the legal basis for the filing. The second surprise is in Section 3.2.1 of that manual: the registration certificate doesn’t necessarily belong to the company that files it.

    I am Julio Martinez-Clark, CEO of bioaccess®. This page explains how to get a device that is already FDA-cleared or CE-marked onto the Bolivian market through the Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED). It sits alongside our LATAM market-access hub, the Bolivia AGEMED country page and the Importer of Record guide. If you are planning a first-in-human study in Bolivia rather than a launch, start with our Bolivia CRO page. This is operator guidance, not a quote and not legal advice.

    One-sentence answer

    Bolivia registers medical devices under Ley 1737 (Ley del Medicamento, 17 December 1996), its regulation Decreto Supremo 25235 (30 November 1998) and AGEMED’s Manual para Registro Sanitario de Dispositivos Médicos. A Bolivian company authorized by Resolución Ministerial files Form 027 through AGEMED’s virtual procedure, with one registration per device group, a 30-business-day issuance target and five-year validity.

    The rule that governs the file

    The manual’s objective (Section 1.2) ties it to Ley 1737, DS 25235 and Decreto Supremo 26873 (the Sistema Nacional Único de Suministro). On Bolivia’s official procedures portal, gob.bo, procedure 82 (registration of an imported medical device) lists its legal basis as Resolución Ministerial 0265 of 25 May 2018 and the device manual approved by Resolución Ministerial 010. It is a virtual procedure with AGEMED as the responsible agency.

    One citation detail matters if you are writing an SOP. Resolución Ministerial 0909 of 7 December 2005 approved the general Manual para Registro Sanitario, which gob.bo uses for medicines. The device manual is a separate document. If your consultant memo cites RM 0909 as the device rule, ask them to check it.

    Classification follows GHTF rules

    Section 1.7 sets four risk classes: I (low), IIa (low-moderate), IIb (high-moderate) and III (high). Section 1.7.2 says Bolivia recognizes the Global Harmonization Task Force classification rules and reproduces all 16 of them, covering non-invasive, invasive and active devices plus the special rules for medicinal substances, tissues, disinfection and contraception. When more than one rule applies, the highest class wins (1.7.1 d). The manual also lets AGEMED reclassify a device based on post-market experience.

    You declare the class yourself. Item 2.4.7 says that if the class isn’t on your certificate of free sale, you state the class the manufacturer assigned.

    One registration per group

    Chapter II opens with a rule many foreign teams miss: devices are registered by group, one registration per group, using the grouping in Annex 2. Annex 2 splits devices into non-invasive, invasive and active families, then numbered groups within each (for example, osteosynthesis implants and joint prostheses together in one invasive group). Section 5.10.2 lets you add items to an existing registration as a rectification, but only if they share the same risk class and group. Map your catalogue to Annex 2 before you count how many filings you need.

    Who can file

    The applicant is a Bolivian establishment, not the foreign manufacturer. The file needs:

    • A copy of the Resolución Ministerial authorizing the company to operate (2.2.1).
    • A current Certificado de Empresa confirming its license, annual re-registration and annual inspection, whether it’s a manufacturer or an importer (2.2.2). Section 5.7.2 requires every company to re-register each year by 31 December.
    • Form 027, signed by the company’s legal representative and by its regente or technical responsible person. The manual lists the professions that can act as technical responsible, from pharmacist to biomedical, electronic or mechanical engineer (2.1).
    • A signed sheet naming who granted the legal representation and until when, the product owner or licensor, the manufacturer and every plant that makes, fills or packs the finished product (2.2.3).

    The manufacturer’s representation document isn’t refiled with every dossier. Section 2.3.4 says it is lodged beforehand, in original, with AGEMED’s vigilance and control area, and that it doesn’t need consularization.

    Who owns the registration

    Section 3.2.1 is the most important paragraph in the manual for a foreign manufacturer. It says the registration certificate does not necessarily belong to the company that processes it; it belongs to whoever holds the product license, or to its manufacturer.

    That gives you a starting point in negotiations, not a guarantee. Your Bolivian importer still holds the operating license, signs Form 027 and appears on the file. Put the ownership language from 3.2.1 into your distribution agreement, together with an obligation to cooperate on any change of company. Have local counsel review it before the first filing.

    What an imported device has to file

    • Quality-system certificate (2.3.1). GMP or an equivalent quality-system certificate, in original or a copy legalized by the health authority (the manual says not necessarily consularized). You need one for every plant, including packaging plants, and it must be no more than two years old. AGEMED can still inspect the plant or ask your home regulator about it.
    • Certificate of free sale (2.3.2). It must be issued or endorsed by the national health authority of the country of origin and legalized by the Bolivian consulate. Where there is no Bolivian consulate, you present the original with a certification from Bolivia’s Ministry of Foreign Affairs. If the certificate states no validity, it’s accepted for two years from issuance. Bolivia joined the Hague Apostille Convention on 7 May 2018, after this text was written, so confirm with AGEMED whether an apostille is accepted in place of consular legalization for your document. Our certificate of free sale post explains why devices that are not yet cleared at home stall here.
    • Technical file (2.4). Parts and components, a certificate of analysis or design verification and validation report, shelf life, storage conditions, an international nomenclature code (ECRI, GMDN or equivalent), lot coding, risk class, instructions-for-use summary, sterilization method and disposal method.
    • Clinical evidence (2.4.8). For high-moderate and high-risk devices, particularly new products, the file includes clinical studies supporting safety and efficacy.
    • Labels (2.5). Multilingual labels are accepted if one language is Spanish. Minimum content is product name, lot or serial number, expiry where applicable, manufacturer and special warnings. Under Article 149 of DS 25235, every package also carries a sticker, stamp or print identifying the Bolivian company that sells it, and the file includes its design.
    • Manuals (2.7). Operating, maintenance and installation manuals must be in Spanish.
    • Samples (2.6). Samples are required only for low-risk devices. For the other classes, AGEMED can verify product at the company’s warehouse at any time.

    Biomedical equipment has an extra declaration (2.9). The manufacturer or Bolivian representative states that the equipment is not experimental, that spare parts and maintenance are available for five years (or the equipment’s life, if shorter), that training is offered, and that manuals are supplied in the original language and Spanish. The holder also reports installed units and their locations every year.

    How the review runs

    Chapter III sets the sequence: pay the service fee, get the payment order, file the dossier, and AGEMED evaluates. The current gob.bo procedure describes the same steps, with the documents loaded through AGEMED’s MISA platform. There are three outcomes:

    • Approved. AGEMED issues the registration with a DI code for imported devices (DN for national ones).
    • Observed. You get a note listing correctable technical observations and have 60 calendar days to answer them.
    • Rejected. Missing core items, such as Form 027, the company documents, the parts description or labels, mean rejection. You can refile for a second evaluation within 60 calendar days, with a new payment.

    Section 3.1.5 says the certificate is delivered within 30 business days of filing, valid for five years. Treat that as AGEMED’s clock for a clean file, not your end-to-end plan: consular or apostille steps, translations and any observation round come on top. Appeals of a rejection go to AGEMED’s quality-assurance committee with a technical justification (5.4).

    After approval

    • Registration number on pack (5.7.1). The number has to be printed, stamped in indelible ink or applied as a sticker in a visible place.
    • Notifications (5.9). Notify AGEMED before marketing starts (the manual’s notifications carry a 15-business-day deadline). Also send a reference sale price before launch or a price change, and notify changes of technical responsible, closures and address changes.
    • Changes (2.10 and 5.10). Non-substantial changes, such as secondary components, packaging, labels, design, power source, manufacturing process, shelf life or company name, are rectifications that keep the original number and validity.
    • Renewal (3.1.7). File in the three months before expiry. The manual gives a short tolerance after expiry, but late renewals are charged as a new inscription.
    • Cancellation (5.11). AGEMED can cancel a registration for undisclosed substantial changes or after an alert review, with market withdrawal at 72 hours, three months or nine months depending on the risk.

    What this file is not

    • It is not a clinical-trial authorization. FIH study approval runs on a separate track; see our Bolivia CRO page.
    • It is not part of the bioaccess® fixed-price market-access subscription. That subscription covers only multi-importer countries plus Argentina. Bolivia is quoted as scoped, manufacturer-funded processing.

    How bioaccess® runs Bolivia registrations

    bioaccess® processes AGEMED registrations funded by the manufacturer. That covers Annex 2 grouping and classification, the Chapter II dossier, the legalization and translation plan, the filing, agency liaison and post-approval notifications. Local counsel reviews your representation document and distribution agreement so that ownership and control stay where you intend them. AGEMED sets its own service fees, and we confirm scope and pricing at proposal. Details: bioaccessla.com/market-access/bolivia-agemed.

    Operator checklist

    1. Cite the device manual and gob.bo procedure 82 (RM 0265/2018, RM 010), not RM 0909, in your SOPs.
    2. Map your catalogue to the Annex 2 groups before you count filings.
    3. Choose a Bolivian importer with a current Certificado de Empresa and a technical responsible who can sign Form 027.
    4. Write the Section 3.2.1 ownership language into the distribution agreement.
    5. Get quality-system certificates under two years old for every plant, and plan legalization of the certificate of free sale early.
    6. Prepare Spanish labels, manuals and the Bolivian seller sticker before filing.
    7. Calendar renewal for the three months before the five-year expiry.