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Tag: ANVISA

  • Adverse event and SUSAR reporting to ANVISA during a FIH trial in Brazil

    Device FIH safety reporting in Brazil is not drug pharmacovigilance with the logo swapped. The clocks are different, the form is different, and “SUSAR” is a useful overlapping idea — not the name of the ANVISA device channel.

    If your FIH data are meant to support a later FDA investigational or marketing file, you still report to ANVISA under device rules. You then keep a narrative and causality trail that an IDE medical officer can read without asking why Brazil used a drug module.

    The statute you actually report under

    Current device clinical-investigation procedure is RDC 837/2023, announced by ANVISA in its December 2023 update. It replaced RDC 548/2021, which had already revoked RDC 10/2015. Chapter VII is the safety-monitoring chapter. Do not write SOPs against RDC 10/2015 clocks, and do not paste RDC 945/2024 drug-trial SUSAR text into a device FIH plan.

    Law 14.874/2024 still applies to the ethics layer. Article 26 requires the sponsor to notify investigators, the institution, ethics bodies, and the sanitary authority of findings that may adversely affect participant safety. Article 55 makes serious adverse events reportable to the CEP that approved the research, and, for clinical trials intended to support sanitary registration, also to the sanitary authority. The law does not replace RDC 837/2023’s device form or day counts.

    NotivisaEC is the device channel; VigiMed is not

    ANVISA’s manual for adverse-event notification and safety monitoring in clinical trials involving investigational medical devices is the operational text. It tells sponsors to notify unexpected serious adverse events to ANVISA on the electronic NotivisaEC form:

    https://pesquisa.anvisa.gov.br/index.php/847543?lang=pt-BR

    The manual is explicit that those notifications go exclusively through that form, and that login is not required to notify. It also states that a SUSAR (suspected unexpected serious adverse reaction) sits inside the criteria for a notifiable serious event — but the RDC criteria are not limited to the drug-style SUSAR definition. If your safety database only flags “SUSAR = yes,” you will miss device cases that are unexpected, serious, and causally possible even when a medical monitor refuses the drug label.

    VigiMed-Pesquisa Clínica is ANVISA’s channel for SUSARs in drug and biologic trials, under the drug clinical-trial framework (currently discussed by the Agency against RDC 945/2024). ANVISA’s own clinical-trial notification page describes VigiMed in that medicine context and requires a study-specific VigiMed registration, including the DEEC expediente. That is not the device DICD file. Do not open a VigiMed-Pesquisa Clínica account as a substitute for NotivisaEC on an implant FIH.

    Post-market technovigilance (commercial devices after registro or notification) is a different duty and a different system generation. Keep investigational NotivisaEC cases out of the commercial technovigilance queue until the unit is actually on the market.

    What is notifiable, in device language

    RDC 837/2023 defines an adverse event as any unfavorable medical occurrence in a participant that is not necessarily causal. A serious adverse event includes death; a life-threatening event; persistent or significant disability; hospitalization or prolongation of hospitalization; congenital anomaly; suspected transmission of an infectious agent via a medical device; or a clinically significant event.

    An event is unexpected when it is not described as an adverse reaction in the investigator brochure or in the instructions for use / operator manual of the investigational device. That is why the brochure is a reporting instrument, not a marketing appendix.

    The sponsor must notify ANVISA of unexpected serious events that occurred in Brazil and whose causality versus the investigational product is possible, probable, or definite. Expected serious events, unrelated events, and non-serious events still belong in the sponsor’s file and in the annual tabulated report. They are not the 7- and 15-day electronic cases.

    Causality is not a hallway opinion. The device manual points sponsors to the WHO-UMC causality scale (possible / probable / certain, plus the lower categories) when classifying every event, including non-serious ones. Train Brazilian investigators on that scale before site initiation. A PI who only knows “related / not related” will force you to re-code under the clock.

    The clocks — investigator, sponsor, ANVISA

    RDC 837/2023 is blunt on time. Count from knowledge, not from “when safety closed the query.”

    • Investigator → sponsor: serious adverse events or death within 24 hours of the investigator becoming aware.
    • Sponsor → ANVISA, fatal or life-threatening, unexpected, causality possible/probable/definite, Brazil: document and notify on the electronic form within 7 calendar days of sponsor awareness. Complementary follow-up goes on the same form within 8 calendar days after that initial notification.
    • Sponsor → ANVISA, all other unexpected serious events meeting the same causality and territory tests: 15 calendar days from sponsor awareness.

    Immediate protective measures are not optional. On a notifiable serious event, the form expects the measures already taken, the plan if the same event recurs, the care location, and identifiers that can trace the event and the participant. Notification is due even if you are in the middle of a brochure update, a protocol amendment, an annual report, or an early termination.

    Temporary safety suspensions of the investigation must be notified to ANVISA within 7 calendar days of the suspension, with reasons, scope, treatment interruption, risk-minimization measures, and recruitment status. Restart waits for ANVISA approval published in the Official Gazette. That is a calendar item, not a medical-monitor footnote.

    DSUR / ICH E2F is not a substitute for the device annual report

    ANVISA publishes the ICH E2F Development Safety Update Report in its medicines clinical-trial library. E2F is a drug-development periodic-safety standard. It is a sensible internal template if the same legal entity also runs an IND. It is not the device annual report that RDC 837/2023 requires.

    For a DICD, the sponsor files an annual follow-up report as a secondary petition to the DICD, covering Brazilian centers only, in tabulated form: title, reference number, recruitment status, amendment history, enrollment by site, deviations and violations by site, and a description of all adverse events in the period, with the case-report-form participant codes. The anniversary is the date of the Brazil start-of-investigation notification. The petition is due within 60 calendar days of that anniversary. Missing the report can cancel the investigation.

    The final report is a different secondary petition, due within 12 months of the investigation’s end date, with demographics, statistical analysis, all events with causality, endpoint results, and any design changes. If you already produce a DSUR for a companion drug or combination product, map the Brazilian device tables into an annex. Do not file the DSUR and assume ANVISA has been served.

    Pivotal high-risk (Class III/IV) designs are expected to constitute a data-monitoring committee. Recommendations go to ANVISA as a DICD addendum within 30 calendar days of the sponsor receiving them. An FIH that is not labeled “pivotal” can still justify a DMC on risk. Write that justification in the plan before first patient, including why you did not constitute one.

    What must stay aligned if the FIH will later support FDA

    FDA device investigations do not use the IND SUSAR clock. They use unanticipated adverse device effect (UADE) rules under 21 CFR 812.150. An investigator reports a UADE to the sponsor and reviewing IRB as soon as possible, and no later than 10 working days after first learning of it. The sponsor evaluates immediately and reports the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 working days of first notice. If the UADE presents an unreasonable risk, termination clocks in 21 CFR 812.46 are 5 working days from that determination and 15 working days from first notice. FDA’s IDE FAQs repeat the same 10-working-day sponsor evaluation report.

    Those clocks will not match Brazil’s 24-hour / 7-calendar / 15-calendar structure. Alignment is not “pick the longer one and hope.” Alignment is a single source narrative:

    • One event identifier from the Brazilian CRF code through NotivisaEC and, if an IDE exists or will exist, through the UADE file.
    • One expectedness baseline — the same brochure version cited in the DICD and in the IDE investigational plan. If Brazil updates the brochure after an unexpected event (RDC 837/2023 requires investigators to be informed and the brochure to be updated), send that version into the FDA file in the same week.
    • One causality sentence that a device reviewer recognizes (device, procedure, disease, concomitant product). Do not let the Brazilian form say “possible” and the IDE memo say “unrelated” without a dated reconciliation.
    • Device identifiers — lot, serial, software version, accessory — on every case. Import traceability under the DICD DOU number is the same data FDA will ask for when the unit later supports a 510(k), De Novo, or PMA.
    • Quality-system evidence that the investigational unit was built under a system you can defend as you move toward the QMSR. A NotivisaEC case that cannot find the device history record is already a future FDA inspection finding.

    If there is no U.S. IDE yet, still write Brazilian cases as if 812.150 will apply later. Reconstructing UADEs from a drug-safety database two years on is how FIH datasets lose credibility.

    Where programs actually break

    The bottleneck is rarely the web form. It is the weekend between the PI’s 24-hour email and a U.S. medical monitor who is still arguing expectedness against an old brochure. Build a Brazil on-call roster that can file NotivisaEC without waiting for California business hours. Give the Brazilian authorized representative and the ORPC (if one is the DICD face) read-only access to the safety tracker. Import holds, ethics queries, and ANVISA inspections all ask for the same case list.

    Second break: treating CEP notification and ANVISA notification as the same send. Law 14.874/2024 sends serious events to the CEP. RDC 837/2023 sends a narrower unexpected-and-related set to ANVISA on NotivisaEC. Your SOP should have two lines, two clocks, two receipts.

    Third break: annual-report amnesia. The 60-day secondary petition is how ANVISA sees aggregate harm. If your data-management lock cannot produce site-level AE tables from Brazilian CRF codes, you will miss a petition that can cancel the DICD — after first patients are already in.

    A practical next step

    Before site initiation, run one tabletop: a fatal unexpected device-related event at 18:00 Brasília on a Friday. Walk the 24-hour investigator notice, the 7-calendar-day NotivisaEC filing, the 8-day follow-up, the CEP notice under Law 14.874/2024, the brochure update, and — if an IDE is live or planned — the 10-working-day UADE evaluation to FDA. If any of those hands is “we’ll figure it out,” rewrite the safety SOP and name the NotivisaEC filer. First-patient week is the wrong time to discover that VigiMed was the only account anyone opened.

  • ANVISA medical device classification rules for FIH studies in Brazil

    Most first-in-human (FIH) delays I see in Brazil do not start on the ANVISA clock. They start earlier, when regulatory affairs treats class as a registration afterthought instead of the decision that decides whether you even file a clinical investigation dossier, what the import petition can carry, and what the investigator brochure must treat as expected.

    This is not another walkthrough of Brazil’s 90-day ANVISA review window, and it is not a recap of Law 14.874/2024. Those calendars matter, but they sit on top of a classification call. If that call is wrong, the clock you are watching is the wrong clock.

    RDC 751/2022 is the class rule, not a slogan

    Collegiate Board Resolution RDC No. 751 of 15 September 2022 is ANVISA’s current framework for medical-device risk classification, labeling and instructions for use, and the notification versus marketing-authorization (registro) regimes. Article 5 places devices in four intrinsic-risk classes:

    • Class I — low risk
    • Class II — medium risk
    • Class III — high risk
    • Class IV — maximum risk

    Articles 6 and 7 then split the premarket path: Classes I and II are subject to notification; Classes III and IV are subject to marketing authorization. ANVISA’s English overview of the same split is on the Agency’s medical devices page.

    Classification is not a marketing preference. It is a rules exercise against the manufacturer’s intended purpose. Annex I of RDC 751/2022 sets the classification rules (duration of use, invasiveness, active energy, implants, special rules). The most stringent applicable rule wins. Software as a medical device is classified on its own intended purpose when it is standalone. In vitro diagnostic devices sit on a separate IVD classification track; do not force an IVD into the same clinical-investigation box as an implant.

    For an FIH program, lock three statements in the same document: intended purpose in Portuguese that will appear on the DICD and later on the registro file; the Annex I rule (or rules) you applied; and the resulting Class I–IV. If clinical, quality, and the Brazilian authorized representative cannot repeat those three lines without hedging, you are not ready to talk about first-patient dates.

    RDC 10/2015 is not the current FIH filing rule

    Sponsors still arrive with “RDC 10/2015” in the regulatory plan. That resolution existed. It is not the current device-investigation statute.

    RDC No. 548 of 30 August 2021 revoked RDC No. 10 of 20 February 2015 (Article 84 of RDC 548/2021). RDC No. 837 of 13 December 2023 then replaced that 2021 text. ANVISA announced the update and the alignment with international practice in its 18 December 2023 notice (in force early January 2024). Article 80 of RDC 837/2023 revokes RDC 548/2021.

    Current device clinical-investigation procedure is RDC 837/2023. Use RDC 10/2015 only as history. Do not cite it as the filing basis for a 2026 FIH.

    How class drives whether you file a DICD

    RDC 837/2023 is explicit about scope. A Dossiê de Investigação Clínica de Dispositivo Médico (DICD) is required for clinical investigations involving Class III or Class IV devices that are not yet registered in Brazil. A registered device studied for an indication different from the indication in the sanitary registration also goes in as a DICD.

    The same resolution carves out investigations that do not go to ANVISA as a DICD, including:

    • clinical performance studies of IVDs;
    • usability/human-factors-only studies (unless the clinical investigation also includes those endpoints among others);
    • investigations of devices already registered in Brazil for the same approved indications;
    • clinical investigations of Class I or Class II devices.

    Class I and II investigations are still expected to follow good clinical practice. RDC 837/2023 points to the Document of the Americas and ISO 14155 as the GCP standard. They still need ethics approval. They do not get a free pass on import controls or on manufacturing quality of investigational units. What they do not get is a DICD as the ANVISA on-ramp.

    That is the classification bottleneck. A U.S. significant-risk implant that an RA lead quietly “simplifies” to Class II to avoid a dossier is not a timeline win. It is a first-patient hold when import, ethics, or a later registro reviewer asks why the intended purpose looks like Rule 8 (long-term surgically invasive / implant) and the file says Class II. The opposite error is also expensive: forcing a true Class II tool through a DICD because someone copied a Class III playbook wastes petition fees and a review cycle you did not owe.

    What the DICD actually has to carry

    When class puts you in DICD scope, RDC 837/2023 consolidates the old two-dossier habit into one submission. The petition typically includes the DICD form, the sanitary-surveillance fee (GRU) or exemption, the investigator brochure, a safety-experience summary (prior human use and any foreign post-market experience), the investigational-device dossier, the clinical investigation plan under GCP, and proof of registration in a WHO ICTRP or ICMJE-recognized trial registry (or that proof at start-date notification if it is not ready at first protocolization).

    ANVISA’s petition checklist for DICD subject 80104 is published in the Agency’s SAT instruction list. Use that list, not a recycled IND table of contents.

    Two operational rules from the same resolution save weeks if you lock them before translators start:

    • The party who files the DICD owns every later secondary petition. Do not let a consultant file “just this once.”
    • An organização representativa de pesquisa clínica (ORPC) may file only when the sponsor has no headquarters or branch in Brazil. If you already have a Brazilian legal presence, that presence is the face of the file.

    RDC 837/2023 gives ANVISA 90 calendar days (dias corridos) to issue a manifestation on the DICD, with a tacit-start path after ethics approval if the Agency is silent. Law 14.874/2024 Article 58 speaks of 90 business days (dias úteis) for primary sanitary analysis of clinical-trial petitions intended to support registration. Those are not the same unit of time. Treat the mismatch as a planning flag; do not invent a hierarchy in a slide. The clock posts already cover activation math. Classification decides whether that math applies to you at all.

    Import, IOR/AR, and QMSR sit on the same class decision

    Investigational units do not enter Brazil on a commercial registro. RDC 837/2023 Chapter IX puts exclusive clinical-use import under sanitary inspection and SISCOMEX release. The importer must cite the Diário Oficial da União resolution number for the DICD grant. Outer packaging must carry that DOU number, storage conditions, and a lot, identification, or serial code that can trace the unit. Quantities are limited to what the investigation needs. Commercialization of those units is prohibited.

    If someone other than the DICD holder imports, both parties sign a delegation-of-import-responsibility document. That is your import authorized representative problem, not a freight problem. The same legal person who will later hold notification or registro as authorized representative should see the investigational import list now. A first-patient kit that is not on the DICD product list will sit on the dock.

    On quality: RDC 837/2023 requires investigational devices, and any placebo or sham, to be manufactured to good manufacturing practice and labeled so they are identifiable as investigational. ANVISA may inspect the manufacturing site against the technical, production, and quality-control story in the DICD. If the same design will later support an FDA marketing file, build those units under the quality system you intend to defend — including the United States Quality Management System Regulation transition — not under a “prototype exception” that you cannot reconstruct.

    What the RA lead must lock before first patient

    Write these eight items as a one-page gate. Do not open the site until each line has an owner and a document ID.

    1. Intended purpose. The Portuguese indication that will classify the device under RDC 751/2022 Annex I and that will appear in the investigator brochure. Changing “long-term implant” to “intraoperative aid” after ethics approval is a new class, not a wording tweak.
    2. Class and rule. Class I–IV plus the governing Annex I rule. Record why neighboring rules were rejected.
    3. DICD yes/no. Apply RDC 837/2023 Articles 2 and 4. Class I/II, same-indication post-market, IVD performance, and usability-only studies are out of DICD scope. Class III/IV unregistered, and new indications on a registered device, are in.
    4. Filing face. Sponsor legal entity in Brazil versus ORPC. Name the person who will own secondary petitions: start/end dates, amendments, annual report.
    5. Import list. Every investigational SKU, spare, and accessory that will clear SISCOMEX, mapped to the DICD form. No “we’ll add the introducer later.”
    6. Expectedness language. The brochure and operator manual define “unexpected” for later safety notification. If the FIH protocol lists risks the brochure omits, you have built a 7- and 15-day reporting trap.
    7. Ethics path. CEP submission under Law 14.874/2024 in parallel with, not after, the sanitary file when a DICD is in scope. Single-CEP review for multicenter protocols is a legal design, not a courtesy.
    8. Start-date discipline. RDC 837/2023 requires start- and end-date forms as secondary petitions within 30 calendar days of each Brazil date. First patient is a regulatory event, not only a clinical one.

    Amendments after that gate are expensive. Substantial changes to the brochure or device dossier that can affect quality or safety wait for ANVISA manifestation (again, 90 calendar days in RDC 837/2023). Substantial protocol amendments that affect participant safety or scientific value wait the same way, except amendments that remove an immediate risk, which you implement and notify. Classification mistakes tend to surface as those amendments.

    A practical next step

    This week, run a 90-minute classification huddle with RA, clinical, quality, and the Brazilian representative. Put the intended-purpose sentence, the Annex I rule, the Class I–IV result, and a yes/no DICD decision on one page. Attach the RDC 751/2022 English text and the RDC 837/2023 scope articles. If those four people cannot sign the page, do not book first-patient week. The calendar you save is not ANVISA’s — it is the month you would have spent unscrewing a class you never locked.

  • ICH E6(R3) Annex 2 Just Hit Step 4 In Rio. Argentina Is Positioned To Be Latin America’s First Adopter. Here’s What That Means For Medtech Sponsors.

    On June 3, 2026, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use convened its biannual Assembly in Rio de Janeiro — the first ICH meeting ever held in Latin America. Brazil’s health regulator, ANVISA, hosted. Among the multiple guidelines under consideration at the meeting, only one was advanced to Step 4 — the final stage of ICH adoption: E6(R3) Annex 2, the guideline that codifies decentralized clinical trial design, pragmatic study architectures, digital health technologies, and real-world data as integral elements of GCP-compliant clinical research.

    For a Latin American clinical research operator that has spent the past sixteen years arguing the case to MedTech, biotech, and radiopharma founders, the June 1 to June 4 sequence in Rio is the most strategically significant positioning event of 2026. The geographic precedent is itself meaningful — ICH governance has historically convened in Geneva, Brussels, Tokyo, or other established regulatory capitals. Selecting Rio de Janeiro and partnering with ANVISA as host signals a structural shift in how ICH governance views Latin American regulatory infrastructure. The substantive outcome — only one guideline elevated to Step 4 at the meeting, and that guideline being the one that defines modern trial design — matters even more for how sponsors will think about LATAM site sequencing over the next 18 to 24 months.

    This post unpacks what Annex 2 actually changes, why the Rio venue matters, and how MedTech sponsors should think about Argentina’s position as the first Latin American jurisdiction structurally ready to accept Annex 2-compliant protocols without amendment.

    What ICH E6(R3) Annex 2 Actually Changes

    ICH E6(R3) is the current Good Clinical Practice (GCP) guideline that all major regulators — FDA, EMA, MHRA, PMDA, Health Canada, and adopting regulators in Latin America — converge on for clinical trial conduct. The most recent revision moved GCP to a risk-based, principle-driven model. Annex 2 extends E6(R3) to explicitly cover the trial designs that have become operational reality over the past five years but lacked formal codification in GCP guidance.

    Specifically, Annex 2 addresses:

    • Decentralized clinical trials (DCTs) — trials where participant interaction with study sites is partially or fully replaced by remote visits, home-based assessments, mobile health units, or telehealth consultations.
    • Pragmatic trial designs — protocols built around real-world clinical settings, with broader patient populations and less restrictive inclusion criteria than traditional efficacy trials.
    • Remote site visits — sponsor monitoring conducted through electronic data review, remote source verification, and risk-based on-site oversight rather than universal in-person visits.
    • Digital health technology (DHT) data capture — continuous glucose monitors, wearable cardiac telemetry, accelerometer-based motion data, smartphone-based patient-reported outcomes, and similar tools used as primary or secondary endpoint capture methods.
    • Real-world data (RWD) — use of electronic health records, claims data, registries, and other non-trial sources as supporting evidence within GCP-compliant studies.
    • Adaptive designs — pre-specified protocol modifications based on accumulating trial data, including sample size re-estimation and arm-dropping decisions.

    The substantive shift in Annex 2 is not new regulation. It is the formal incorporation of these design elements into GCP rather than treating them as exceptions that require special justification. For sponsors who have been building modern trial designs over the past five years, the legal architecture finally caught up with the operational reality.

    Why The Rio Venue Matters

    ICH Assembly meetings rotate among the home jurisdictions of ICH members. Hosting the meeting is a substantive role — the host regulator coordinates logistics, sets the agenda for site-specific discussions, and shapes the framing of how the meeting’s outcomes are communicated to global stakeholders. ANVISA hosting the June 2026 Assembly is the strongest signal to date that Brazilian regulatory infrastructure is converging with ICH governance not as an observer but as an active participant.

    For Brazilian sponsors and CROs, the immediate implication is that ANVISA’s preparation for formal E6(R3) adoption is now visible in a way it was not six months ago. The May 28, 2026 ANVISA board session that explicitly addressed ICH E6 and E8 implementation preparation was the first concrete signal. The June 3 Assembly hosting is the next, much stronger signal. Brazilian formal E6(R3) adoption has no publicly announced timeline yet, but the operational trajectory is no longer in doubt.

    For Argentina, the implication is different but equally substantive. Argentina’s ANMAT, under Disposición 7516/25 operative since December 1, 2025, already maintains a regulatory framework aligned with E6(R3) principles. Argentina did not need to host the Rio Assembly to be ready for Annex 2 — it was already there. What the Rio Assembly does for Argentina is confirm that its regulatory positioning was correctly anticipated, and accelerate the speed at which ANMAT can absorb Annex 2-aligned protocols from sponsors.

    Argentina As The First LATAM Annex 2-Ready Jurisdiction

    Disposición 7516/25 modernized Argentina’s clinical trial framework along several dimensions that align directly with E6(R3) principles: a 62-day parallel ethics and agency review pathway, ICH E6(R3) substantive alignment in protocol structure expectations, and operational mechanisms for risk-based monitoring and remote oversight. Critically for Annex 2, Disposición 7516/25 does not preclude decentralized design elements, DHT data capture, or pragmatic patient populations — it accommodates them.

    The practical consequence is that sponsors designing Annex 2-compliant protocols for FDA or EMA submission in 2026 and 2027 do not face a structural barrier to LATAM site inclusion when Argentina is the lead LATAM jurisdiction. Brazil, Colombia, Mexico, and other LATAM regulators have not formally adopted E6(R3), let alone Annex 2 — meaning protocols built around decentralized or DHT-enabled designs face higher regulatory friction in those jurisdictions until each regulator adopts the guidance domestically.

    For Brazil, the trajectory is unambiguous post-Rio. ANVISA hosting the Assembly, the May 28 board session on E6 and E8 preparation, and the substantive operational alignment between ANVISA’s technovigilance and clinical research frameworks all point toward formal E6(R3) adoption in 2026 or 2027. Annex 2 acceptance follows.

    For Mexico (COFEPRIS), Colombia (INVIMA), and other LATAM regulators, the path is less defined. Colombia’s pending Decreto Único de Dispositivos Médicos e In Vitro (currently in WTO comment phase with a July 17 deadline) introduces international reliance pathways that may indirectly accelerate Annex 2 acceptance, but no formal adoption has been signaled.

    Operational Implications For MedTech Sponsors Designing 2026-2027 Protocols

    For a MedTech sponsor designing a protocol today for a 12 to 18 month FIH-to-pivotal sequence, three operational questions matter immediately.

    First, should the protocol be built Annex 2-compliant from the start? The answer is almost always yes if any of the following apply: DHT-collected endpoints are part of the endpoint set; the patient population is large enough that pragmatic design considerations would materially expand enrollment; remote visits or telehealth consultations would meaningfully reduce participant burden; or the trial design contemplates pre-specified adaptive elements such as sample size re-estimation. Building Annex 2-compliant from the start adds modest protocol-authoring effort and substantial future flexibility.

    Second, how should LATAM country sequencing change? For 2026 and through Q2 2027, Argentina-primary is now the recommended LATAM lead jurisdiction for any Annex 2-aligned design. Disposición 7516/25 is the only operative LATAM framework that can absorb the design without amendment. Brazil-secondary is appropriate as ANVISA formalizes its adoption. Mexico and Colombia remain opportunistic, evaluated on therapeutic-area depth and sponsor-specific operational requirements rather than as primary LATAM hubs for decentralized designs.

    Third, what about sponsors with existing LATAM site relationships built around traditional trial architectures? The Annex 2 guidance does not invalidate traditional trial designs. Sponsors running fully on-site, non-decentralized protocols can continue without adjustment. The shift matters for sponsors whose product strategy is built around DHT-collected endpoints or decentralized data capture — for whom the regulatory architecture in LATAM was previously a bottleneck and now is not.

    What Comes Next

    National regulator implementation of E6(R3) Annex 2 will proceed on independent timelines through 2026 and 2027. FDA has signaled implementation guidance is forthcoming. EMA has indicated alignment without formal adoption schedule. PMDA and Health Canada are expected to follow. In Latin America, ANMAT is positioned to be the first formal adopter, followed by ANVISA. The realistic timeline for ANMAT formal Annex 2 acceptance is Q4 2026 to Q1 2027. ANVISA follows in H1 2027 to H2 2027.

    For sponsors making 2026 country sequencing decisions today, the implication is straightforward. Argentina is positioned as the natural lead LATAM jurisdiction for Annex 2-aligned protocols. Brazil follows. Mexico and Colombia continue to be evaluated case-by-case based on therapeutic-area depth and sponsor-specific requirements.

    The Bottom Line

    Latin America is no longer at the edge of global GCP. The June 3 Rio Assembly, the ANVISA hosting of the meeting, and the Step 4 advancement of E6(R3) Annex 2 together signal a structural shift that sponsors building modern trial designs should integrate into 2026-2027 strategy now rather than after the fact.

    The most expensive country sequencing decision is not the one made wrong. It is the one made too late, after the trial design has been frozen and the regulatory pathway is already constrained by choices that no longer reflect the current landscape.

    If you are evaluating an Annex 2-aligned FIH protocol for 2026 or 2027 and want a LATAM country sequencing analysis that integrates the new Rio Assembly outcomes, the team at bioaccess® can produce a tailored proposal within two weeks. We have run first-in-human and pivotal-stage trials across Argentina, Brazil, Colombia, Mexico, and Panama since 2010, and our U.S. EFS plus LATAM FIH practice is the only one in Latin America structured to deliver both pathways under a single operational team.

    Citations:

  • Brazil’s 90 Day Clinical Trial Review Cap: What Medtech Sponsors Should Do Before Submitting

    Brazil’s 90-Day Clinical Trial Review Cap: What MedTech Sponsors Should Do Before Submitting

    Brazil has moved from being a “high-potential but unpredictable” country for early-stage MedTech studies to a jurisdiction with a defined statutory review clock. For sponsors, that shift is not just a speed story — it is a planning story. When review timelines become shorter and more predictable, the relative impact of preventable sponsor-side errors gets larger.

    This article is written for MedTech founders, clinical operations leaders, and regulatory directors who want to run first-in-human (FIH) or early feasibility work in Brazil without losing weeks to rework. We focus on what you can control before submission: dossier readiness, ethics strategy, local operational prerequisites, and vendor orchestration.

    Why a faster regulatory clock changes the sponsor playbook

    Short timelines compress decision-making. If you used to “fix it after ANVISA feedback,” you may no longer have that luxury — because site contracts, import permits, radiology workflows, and ethics committee coordination can become the rate-limiting steps. A faster clock also forces clearer internal governance: who owns the final protocol, the risk assessment, the device technical file, and the country-specific annexes?

    Practically, the sponsor question becomes: How do we arrive at Day 0 with no missing pieces? The goal is to avoid pauses caused by translation gaps, document format mismatches, incomplete investigator packages, or unaligned device documentation.

    Pre-submission checklist: what to lock down before Day 0

    • Protocol version control: Confirm the final protocol, synopsis, schedule of assessments, and statistical plan are aligned — and that the same versions appear in every submission component.
    • Risk classification and device description: Ensure the device description, intended use, instructions for use, and risk analysis are consistent across documents. Inconsistency is one of the most common sources of questions.
    • Investigator and site packages: Collect CVs, training evidence, GCP documentation, and site capabilities early. In Brazil, the operational readiness of sites can become as important as the regulatory dossier.
    • Translations and local formatting: Build time for Portuguese localization and formatting checks. A strong translation is not only linguistic — it must preserve clinical meaning and match annex references.
    • Informed consent strategy: Prepare consent language that is clear, compliant, and aligned to local norms. If your device includes software, connectivity, or data transfer, incorporate that into consent and data handling text.
    • Import and logistics planning: Map the path for device shipment, labeling, and storage. Even for non-radioactive devices, customs, temperature needs, and distribution responsibilities can derail timelines.

    Parallel ethics + regulatory review: how to operationalize it

    When a system allows parallel tracks, the bottleneck often shifts to coordination. Sponsors should treat ethics submission as a project with its own critical path, not as an administrative afterthought. Build a unified submission calendar and align on:

    • Sequence of internal approvals: Decide who signs off on ethics content and who owns final responses.
    • Site-by-site variance: Even with a national framework, each site can introduce operational nuance. Standardize as much as possible, but plan for local adjustments.
    • Response management: Pre-write response templates for common questions (risk/benefit, recruitment strategy, device safety, data management) so you can move quickly.

    For FIH and early-stage work, ethics committees will often focus on patient protection and feasibility: training, emergency procedures, follow-up, and the practical ability of the site to manage adverse events. Your dossier should show readiness, not just compliance.

    What MedTech sponsors often underestimate in Brazil

    Speed-friendly frameworks do not eliminate complexity; they amplify the cost of under-planning. The most common underestimates include:

    • Data and privacy workflows: If your study uses digital endpoints or remote monitoring, align data flows, storage, and access controls early.
    • Device accountability: Plan how devices will be tracked, stored, returned, and reconciled. Accountability gaps create audit risk and can slow activation.
    • Training: Documented training is not optional in early-stage device studies. Build training into your timeline and capture evidence systematically.
    • Vendor interdependencies: CRO, imaging core lab, shipping/logistics, and local regulatory support must operate from the same timeline assumptions and document set.

    FAQ

    1) Does a statutory review cap guarantee approval in 90 days?
    No. A cap can improve predictability, but the practical timeline still depends on dossier quality, completeness, and how quickly questions are resolved.

    2) Should we treat Brazil as a first-choice country for FIH studies?
    Brazil can be compelling when the patient population, investigator expertise, and activation path fit the product. Sponsors should evaluate Brazil alongside other Latin American jurisdictions based on feasibility, ethics speed, and operational readiness.

    3) What’s the biggest sponsor-side mistake?
    Submitting with misaligned documents (protocol vs. device description vs. risk file) and assuming issues can be fixed “during review.” In faster systems, that approach often costs more time, not less.

    Bottom line: If your goal is to capture the benefit of a faster review framework, your work starts well before Day 0. A sponsor-side checklist — executed early — is often the difference between a fast approval and a slow cycle of preventable questions.

  • Law 14.874/2024 Explained: How Brazil’s 90‑Business‑Day Review Window Changes Early‑Stage Clinical Trial Planning

    Law 14.874/2024 Explained: How Brazil’s 90‑Business‑Day Review Window Changes Early‑Stage Clinical Trial Planning

    For MedTech and Biopharma teams considering Latin America, Brazil has historically been seen as a high-potential but hard-to-predict jurisdiction for early-stage clinical trials. That uncertainty can inflate budgets and push teams toward smaller, single-country feasibility strategies.

    Brazil’s Law No. 14.874/2024 introduced a clear constraint: for primary petitions for clinical trials with humans (for marketing authorization purposes), the health analysis may not exceed 90 business days. The law also describes how additional information requests affect the clock.

    This article explains what the 90-business-day window means in practical terms, how sponsors can build a sponsor-ready activation timeline around it, and what pitfalls still cause delays even in a more predictable regime.

    What the law changed (and what it did not)

    The most sponsor-relevant shift is that a defined review window reduces planning ambiguity. A predictable maximum review duration enables better parallelization: ethics preparation, site contracting, and supply chain setup can be scheduled against a more reliable regulatory milestone.

    However, a legal review window does not automatically eliminate operational delays. Sponsors still need to manage:

    • Dossier completeness and consistent technical documentation
    • Ethics sequencing across institutions and committees
    • Import readiness for investigational product shipments
    • Site activation capacity (training, contracting, scheduling)

    In other words, the “clock” helps the regulatory portion of the critical path—but the rest of the program still needs a plan.

    Translating “90 business days” into an activation timeline

    Sponsors often underestimate how different business days can be from calendar days when building a global timeline. A pragmatic approach is to create three layers:

    • Regulatory layer: submission, review window, and potential information request handling
    • Ethics layer: committee submissions and approvals (often overlapping but not identical to regulatory steps)
    • Operations layer: contracts, budget approvals, training, and supply chain readiness

    A sponsor-ready planning template for Brazil should include:

    • Week 0–2: lock document ownership, finalize submission-ready dossier, confirm translation requirements, and run an internal quality check.
    • Week 2–4: submit to the relevant bodies; initiate site contracting and budget cycles in parallel.
    • During review window: implement a weekly “readiness review” covering import documentation, device labeling alignment (if applicable), training scheduling, and monitoring plans.
    • Upon clearance + ethics alignment: initiate first shipment, conduct site initiation, and begin enrollment.

    The objective is to avoid a common failure mode: regulatory clearance arrives, but operations are not ready—so the team loses the predictability advantage that the defined window provides.

    How information requests can still create delays

    Even with a defined maximum window, sponsors should plan for information requests. The practical lesson is to assume that the first submission must be as complete as possible, and that the team must be ready to respond quickly.

    To reduce the chance of delays:

    • Assign a single submission owner responsible for consistency across protocol, investigator brochure (if applicable), device dossier, and administrative documents.
    • Create a rapid-response package before submission: technical specs, risk management summaries, labeling variants, and manufacturing documentation.
    • Pre-brief sites on likely follow-up questions so responses do not stall waiting for institutional input.

    Speed matters because information requests often pause progress until the sponsor responds, and slow responses can negate the benefits of the defined review period.

    Why Brazil’s predictability matters for LATAM multi-country strategy

    For some early-stage teams, Brazil may now be easier to include in a multi-country Latin America strategy when paired with other jurisdictions. The strategic value is not only speed—it is credibility of planning. When leadership teams can explain why the timeline is realistic, financing, vendor contracting, and site commitments become easier.

    To maximize the benefit, sponsors should treat Brazil as one component of a LATAM activation architecture:

    • Define a country sequencing strategy (which country starts first and why)
    • Standardize document templates across countries (with country annexes)
    • Build a supply chain plan that can support staggered activations without stockouts

    When done well, the result is not just a faster first patient in; it is a trial program that is easier to scale.

    FAQ

    Does the 90-business-day window guarantee approval?

    No. A defined window is about timing, not outcome. Sponsors still need a complete, well-justified dossier and an operational plan that supports ethics and site readiness.

    Should early-stage sponsors wait for Brazil before activating other LATAM countries?

    Not necessarily. Many sponsors can run activities in parallel across countries. The right choice depends on device complexity, supply chain constraints, and how quickly the sponsor can support multiple site activations.

    What is the single biggest mistake sponsors make with “faster” regulatory timelines?

    Assuming that regulatory speed automatically creates operational speed. The winning approach is to use predictability to parallelize work—contracts, training, and import readiness—so the program is ready when clearance arrives.

    Bottom line: Brazil’s Law 14.874/2024 gives sponsors a more predictable planning horizon. The teams that benefit most will be the ones that treat the regulatory window as a scheduling tool—and execute the operational readiness plan in parallel.

  • Brazil’s 2025 Clinical Research Rulebook: What Early-Stage Sponsors Should Do Differently

    Brazil’s 2025 Clinical Research Rulebook: What Early-Stage Sponsors Should Do Differently

    Brazil continues to be one of the most important anchors for early-stage clinical development in Latin America, but the compliance baseline is moving. In 2026, Anvisa highlighted that Brazil’s clinical research environment has been updated through Law No. 14.874/2024 (ethical aspects of research with human beings) and the newer regulatory package RDC 945/2024 plus IN 338/2024 for clinical research supporting registration of medicines, which Anvisa notes took effect in early 2025 (Anvisa).

    For MedTech founders and regulatory directors planning first-in-human (FIH) or early pivotal work in the region, the strategic opportunity remains: access to experienced investigators, high-quality sites, and diverse patient populations. The operational requirement, however, is to design submissions, vendor oversight, and essential documentation so you can demonstrate control at any moment—especially as inspection programs mature.

    1) What changed in Brazil’s research governance—and why it matters for sponsors

    Anvisa’s 2025 activity reporting explicitly connects the new ethical law and the updated clinical research regulation to the agency’s current oversight approach (Anvisa). In parallel, Anvisa’s inspection metrics reporting emphasizes inspection readiness against GCP expectations (ICH E6 (R2) or updates) while referencing RDC 945/2024 and Law 14.874/2024 as part of the inspection framework (Anvisa).

    Practical takeaway: even when timelines are competitive, sponsors should assume that documentation quality, vendor governance, and data integrity controls will be evaluated more explicitly. This is good news for well-prepared early-stage teams: strong fundamentals can shorten back-and-forth with sites and reduce downstream remediation.

    2) A sponsor-ready timeline: how to think about “FIH speed” without compliance debt

    Internal execution experience across Latin American programs repeatedly shows that speed usually breaks down in predictable places: incomplete essential documents, misaligned responsibilities between sponsor and CRO, and late-stage changes to protocol and informed consent artifacts. Treat “speed” as a systems outcome rather than a hero effort.

    • Pre-submission (4–8 weeks): lock protocol operational feasibility, confirm investigational product/device logistics, and establish a document control plan.
    • Submission-ready package: create a single source of truth for protocol, IB/IFU (as applicable), safety reporting plan, and data handling plan.
    • Site activation: standardize training, delegation, and vendor onboarding so the first site is not a one-off build.

    Many startups underestimate that “time to first patient” is often constrained by operational readiness, not just authority review. Investing early in a repeatable activation model is one of the highest ROI moves you can make.

    3) Inspection readiness: build once, benefit for years

    Anvisa’s inspection metrics report notes its focus on inspections conducted in 2024 and 2025 and positions inspections as a tool to protect participants and data integrity (Anvisa). For early-stage sponsors, the implication is clear: build inspection readiness into your operating rhythm rather than treating it as a “phase 3 problem.”

    Start with five non-negotiables:

    • Essential document discipline: version control, signatures, and clear ownership.
    • Delegation and training: role-based training mapped to tasks; keep it auditable.
    • Deviation and CAPA workflow: define severity levels and timelines; trend issues.
    • Vendor oversight: documented qualification, KPIs, and periodic review for CROs, labs, and logistics partners.
    • Data integrity: audit trails, access controls, and reconciliation between source, eCRF, and safety database.

    4) How to operationalize this across Latin America (not just Brazil)

    Brazil is rarely the only country in a Latin America strategy. Use Brazil as the quality anchor and replicate the same operating system across additional countries. You can localize what must be localized (ethics committee formats, language, import processes), while keeping your core compliance artifacts stable.

    A useful mental model: create a regional master file (core documents, SOPs, training), plus country modules (local submissions, contracts, import permits), plus site modules (delegation, logs, training, monitoring).

    FAQ

    When did Brazil’s latest clinical research regulations take effect?
    Brazil’s updated framework referenced by Anvisa includes Law 14.874/2024 (in force since 29 Aug 2024) and RDC 945/2024 plus IN 338/2024 (effective 2 Jan 2025).

    Do these changes apply to medical devices too?
    The Anvisa updates cited relate to clinical research for registration of medicines and biologics; device sponsors should still align operational quality systems and inspection readiness to ICH GCP expectations and local ethics requirements.

    How should startups prepare for inspection readiness?
    Build inspection-ready documentation from day one: role-based training, version-controlled essential documents, delegation logs, deviation management, and vendor oversight that can be demonstrated quickly.

    Need help designing a Latin America FIH plan? bioaccess® supports sponsors with regional feasibility, activation, and execution strategies built for speed and inspection readiness.

  • First-In-Human In Brazil In 2026: A Practical Timeline For Sponsors

    First-in-Human in Brazil in 2026: A Practical Timeline for Sponsors

    Primary keyword: first-in-human trial Brazil timeline

    Brazil is increasingly on the shortlist for early-stage clinical development because sponsors can combine a large patient base with growing regulatory clarity. A recent policy analysis argued that Lei 14.874 de 2024 created the basis for a more predictable environment and, for the first time, establishes timelines and greater regulatory clarity for clinical studies.

    This article gives a practical, sponsor-side timeline for launching a first-in-human (FIH) study in Brazil in 2026—what to do first, what typically slows teams down, and how to sequence work so you do not lose weeks to preventable back-and-forth.

    1) Define the “Brazil-ready” FIH package (Weeks 0–2)

    Before any submission, align internal stakeholders on what “Brazil-ready” means. For most MedTech and biopharma sponsors, FIH readiness is not only a protocol question—it is also a documentation and site execution question.

    • Protocol and IB alignment: Ensure endpoints, safety monitoring, and dose-escalation logic are consistent with your global plan.
    • Country adaptations: Identify what must be localized or supplemented (consent language, site materials, labeling, and investigator documentation).
    • Feasibility assumptions: Confirm whether required imaging, lab, or procedural capabilities exist at target sites.

    Internal best practice: Create a single “FIH Brazil master checklist” with owners and due dates. Treat it as a deliverable, not an afterthought.

    2) Select sites for speed, not just prestige (Weeks 1–4)

    In FIH, startup speed is highly correlated with site readiness. Sponsors often choose sites based on reputation, then discover contracting and operational realities late.

    • Prioritize operational maturity: Look for sites with dedicated research staff, established ethics processes, and experience with sponsor audits.
    • Validate recruitment pathways: Treatment-naive populations can be an advantage, but referral networks still matter.
    • Assess import and handling constraints: If your study uses temperature-sensitive materials, confirm storage and chain-of-custody procedures early.

    3) Build a parallel workstream plan (Weeks 2–6)

    The most common timeline mistake is running tasks sequentially that can be executed in parallel. Even when formal review clocks improve, sequential execution can erase the benefit.

    To compress time, run these workstreams at the same time:

    • Regulatory dossier preparation (quality, safety documentation, and trial authorization package)
    • Ethics submission package (site-specific documents and consent)
    • Contracts and budgets (CTA, indemnities, payment schedules, and monitoring model)
    • Supply and logistics readiness (import planning, labeling, storage validation, and back-up scenarios)

    Even when legal reforms aim to improve predictability, sponsors still need coordinated execution across stakeholders to realize those gains.

    4) Anticipate “hidden” startup time: contracts, import, and training (Weeks 4–10)

    Even when review timelines are favorable, sponsors can lose time after approvals due to operational bottlenecks:

    • Contract negotiation cycles: Build buffer time for legal review, redlines, and institutional sign-off.
    • Import and release: If your investigational product or device must be imported, confirm lead times and documentation requirements early.
    • Site initiation and training: FIH trials require strict adherence to safety procedures; schedule training sessions while approvals are in progress.

    Practical tip: Maintain a “go-live readiness dashboard” that tracks contract status, shipment readiness, and training completion. This prevents surprises when the green light arrives.

    5) A sponsor-friendly 2026 FIH timeline (example)

    Every program is different, but a realistic planning template looks like this:

    • Weeks 0–2: Brazil-ready protocol package, checklist, and internal alignment
    • Weeks 1–4: Site selection, feasibility, and early budget/CTA drafts
    • Weeks 2–6: Parallel dossier + ethics package finalization
    • Weeks 4–10: Contracts, import planning, training, and vendor setup
    • Weeks 10–14: Final site activation steps and first-patient readiness

    If you are aiming for speed, measure time-to-ready as rigorously as you measure time-to-approval. In many FIH programs, the fastest sponsors are simply the ones that avoid rework.

    FAQ: First-in-human trial Brazil timeline

    • How long does it take to start a first-in-human trial in Brazil?
      Timelines vary by protocol complexity and site readiness, but sponsors should plan for parallel regulatory and ethics pathways, early document localization, and realistic contracting and import lead times.
    • What is the biggest cause of FIH delays in Brazil?
      In practice, delays often come from incomplete documentation, late site selection, and underestimated startup logistics (contracts, import permits, and investigational product readiness), not just the formal review clock.
    • Can Brazil FIH data support US or EU submissions?
      Yes, when the trial is designed to international GCP standards and endpoints align with your global regulatory strategy, Brazilian data can be part of a broader evidence package.

    Need help planning an FIH startup in Brazil or across Latin America? bioaccess® supports sponsors with country startup planning, site activation, and operational execution—without exposing confidential details publicly.

  • Regulatory Harmonization in Latin America: What ANVISA’s Regional Cooperation Signals for Multi‑Country MedTech Trials

    Regulatory Harmonization in Latin America: What ANVISA’s Regional Cooperation Signals for Multi‑Country MedTech Trials

    Latin America is not a single regulatory market, but the region is moving toward more structured cooperation, reliance, and convergence. For MedTech sponsors running multi-country clinical programs, these shifts matter because they can change how dossiers are prepared, how evidence is reused, and how activation risks are managed.

    In June 2026, ANVISA reported participating in a PAHO-organized Regional National Regulatory Reference Authorities (NRAr) meeting in Buenos Aires focused on strengthening regulatory systems and expanding international cooperation. ANVISA also described bilateral discussions with multiple agencies (including FDA, Cofepris, Anmat, and Invima) and highlighted signing a memorandum of understanding with Colombia’s regulator to enable confidential information exchange and support reliance initiatives.

    These developments do not eliminate country-by-country requirements. However, they signal a direction of travel: more formal cross-border collaboration, more alignment on good regulatory practices, and potentially more predictability for sponsors who plan strategically.

    1) Why “harmonization” matters for MedTech trial execution (not just strategy)

    When teams hear “regulatory harmonization,” they often think of policy. Operationally, the real value comes from:

    • Reuse of core evidence packages across multiple authorities
    • Fewer contradictory requirements that force protocol redesign
    • More predictable review expectations when agencies align with shared standards
    • Reduced activation friction when documentation formats converge

    For early-stage MedTech sponsors, reducing friction is not a luxury. It can be the difference between hitting a funding milestone and needing a bridge round.

    2) What ANVISA’s recent cooperation activity suggests

    ANVISA’s public update indicates three practical signals for sponsors:

    • Regional capacity-building is a priority: the NRAr meeting agenda included mechanisms for convergence and innovation, plus updates to PAHO’s regional policy for strengthening regulatory systems.
    • Reliance is becoming more explicit: ANVISA described an agreement with Colombia’s regulator to enable confidential information exchange and support reliance initiatives.
    • Global credibility is a strategic goal: ANVISA highlighted progress toward WHO Listed Authority (WLA) recognition, which can influence how other stakeholders view Brazilian regulatory decisions.

    None of this means that a sponsor can file once and be approved everywhere. But it does mean sponsors should expect more structured cooperation and should design their evidence and documentation to be “portable.”

    3) How to design a “portable dossier” for Latin America

    A portable dossier is not a one-size-fits-all PDF. It is a controlled set of core modules that can be adapted with minimal rework. Practical components include:

    • Master protocol with annex-ready country adaptations (contact details, lab references, safety reporting specifics)
    • Device description and risk analysis aligned to internationally recognized principles (clear intended use, hazards, mitigations)
    • Clinical evaluation narrative that ties early feasibility data to the next evidence step
    • Quality and traceability package that supports import, accountability, and post-trial device handling

    The goal is to reduce “translation churn”—not just language translation, but repeated rewriting driven by different templates.

    4) Planning multi-country activation under partial convergence

    Even with convergence, activation remains a network problem. Practical planning considerations include:

    • Choose an anchor country with predictable timelines and strong sites to generate early momentum.
    • Open a second wave in parallel where operational readiness is high and import pathways are clear.
    • Use timeline intelligence from authoritative resources: for example, NIH ClinRegs summarizes that Brazil’s Law No. 14.874 sets a 90-business-day deadline for ANVISA’s analysis of primary petitions for clinical trials, while Peru’s INS must complete review and approval of a clinical trial application within a maximum of 30 working days.

    These published timelines are not the entire story, but they are a useful starting point for scenario planning and stakeholder alignment.

    5) What to watch next (and how to stay ahead)

    Regulatory convergence tends to move in “bursts,” driven by new policies, pilot programs, and bilateral agreements. Sponsors can stay ahead by:

    • Monitoring regulator cooperation news from agencies and PAHO
    • Building evidence packages that align with shared standards so they remain reusable as convergence increases
    • Running pre-activation risk reviews that consider import, ethics, and site readiness in each target country

    The most successful teams treat regulatory strategy as an operational lever. Convergence is valuable, but only if you translate it into a concrete activation plan.

    FAQ: Regulatory harmonization and multi-country trials in Latin America

    Is Latin America becoming a single regulatory market for MedTech trials?

    No. Each country retains its own laws and authorities. However, cooperation and convergence efforts can reduce friction and improve predictability over time.

    What recent sign suggests increased cooperation?

    ANVISA publicly described participating in PAHO’s NRAr meeting in Buenos Aires and reported signing a memorandum of understanding with Colombia’s regulator to enable confidential information exchange and support reliance initiatives.

    How should sponsors respond today?

    Design a portable dossier, plan activation as parallel workstreams, and sequence countries based on both published timelines and on-the-ground operational readiness.

    Bottom line: regulatory harmonization is not a shortcut, but it is a trend sponsors can operationalize. Teams that build portable evidence and plan multi-country activation around predictable processes will be best positioned as convergence accelerates.

  • Brazil’s 90‑Business‑Day ANVISA Clock: How to Plan First‑in‑Human Activation Without Bottlenecks

    Brazil’s 90‑Business‑Day ANVISA Clock: How to Plan First‑in‑Human Activation Without Bottlenecks

    Brazil has moved from “unpredictable timelines” to a more clock-driven model for key clinical trial petitions. According to the U.S. NIH ClinRegs Brazil overview, Law No. 14.874 requires ANVISA’s analysis of primary petitions for clinical trials (including Clinical Drug Development Dossiers, DDCMs) to be completed within 90 business days. This is a meaningful planning advantage for MedTech and Biopharma teams designing first‑in‑human (FIH) or other early-stage studies in Latin America.

    But a defined regulator timeline does not automatically translate into a fast first-patient-in. Activation can still stall due to ethics sequencing, site contracts, import permits, labeling, budgeting, and operational readiness. The sponsors who benefit most are the ones who orchestrate the entire activation system around the review clock—not just the regulatory submission.

    This article provides a practical playbook for using Brazil’s defined review window to reduce uncertainty without compromising compliance. It is written for MedTech founders, clinical operations leaders, and regulatory directors planning early clinical evidence generation in Latin America.

    1) What the “90‑business‑day clock” means (and what it doesn’t)

    In many countries, the biggest activation challenge is not the technical content of the dossier—it is uncertainty. When timelines drift, every downstream dependency becomes harder: site selection, device logistics, vendor contracting, and financing.

    Brazil’s framework has introduced a clearer expectation. ClinRegs summarizes that ANVISA’s analysis of primary petitions for clinical trials with human beings “must be completed within 90 business days” under Law No. 14.874, with related implementing details in Resolução RDC No. 945 (including how the 90 business days are counted for DDCM/DEEC petitions).

    Important nuance: a regulator timeline is one piece of a multi-track activation pathway. If the sponsor treats the ANVISA clock as the entire schedule, they can still lose weeks or months elsewhere.

    2) Build an activation timeline like a network, not a checklist

    Fast activation is usually the result of parallelization, not heroics. A useful way to plan is to treat each workstream as a node in a network:

    • Regulatory dossier readiness (DDCM/DEEC content, translations, country-specific annexes)
    • Ethics committee readiness (Brazil CEP/CONEP strategy, submissions, anticipated questions)
    • Site readiness (feasibility, equipment, training, contracts, budgets)
    • Import and logistics readiness (customs broker, labeling, packaging, temperature control, returns)
    • Data and safety operations (eCRF build, SAE workflows, vendor setup, monitoring plan)

    In early-stage MedTech programs, the “critical path” often shifts midstream. For example, the device may be available, but site contract negotiation drags. Or the site is ready, but import documentation is incomplete. A network view helps you see what must be done in parallel so that the 90-day review window is not wasted.

    3) A practical pre-submission readiness package (what to have done before day 0)

    To benefit from predictable review windows, sponsors should aim to begin ANVISA review with minimal “churn” during the clock. In practice, this means building a readiness package before the submission date. Common elements include:

    • Protocol that is operationally executable: endpoints, visit schedule, and device handling that local sites can implement.
    • Risk-driven monitoring and safety plan: proportional to first-in-human risk, with clearly defined escalation pathways.
    • Brazil-ready informed consent: culturally appropriate language; processes for re-consent if amendments occur.
    • Import map: who will act as importer-of-record, how devices will be labeled, and the evidence trail for traceability.
    • Site contracts and budgets in draft form: so legal review does not become the gating item after regulatory clearance.

    Internal experience across Latin America shows that when sponsors plan only the submission, they often discover the “real bottleneck” later. Conversely, when they package readiness early, they can compress time-to-site-initiation after regulatory clearance.

    4) Common activation bottlenecks in Brazil (and how to design around them)

    Even with a defined regulator timeline, teams can lose time in avoidable areas. Here are recurring bottlenecks and practical ways to design around them:

    • Ethics sequencing misunderstandings: plan early for CEP/CONEP pathways and expected document sets; align translations and investigator documents up front.
    • Device logistics not protocolized: define receipt, storage, accountability, and disposal processes inside the protocol and site manuals.
    • Training delays: schedule investigator meetings and device training as soon as sites are selected; do not wait for final approvals to build training assets.
    • Budget misalignment: ensure site budgets reflect local realities (procedures, imaging, follow-up) to reduce renegotiation cycles.

    Operationally, the fastest programs are those where regulatory and operations leaders co-own the activation timeline, instead of treating it as a handoff from “regulatory” to “clinops.”

    5) How to use Brazil’s timeline advantage in a multi-country Latin America strategy

    Brazil’s defined review window can be especially valuable when used as one “anchor country” in a broader Latin America evidence strategy. Sponsors often seek to generate credible early data quickly, then expand into additional markets.

    To do this effectively:

    1. Design the protocol for exportability: align endpoints and data standards with future regulatory and reimbursement conversations.
    2. Standardize your core dossier: build a master package that can be adapted for different authorities without reinventing content.
    3. Plan the expansion pathway early: identify which countries can open in parallel (based on timelines, import complexity, and site readiness).

    For example, NIH ClinRegs indicates Peru’s INS must complete review and approval of a clinical trial application within a maximum of 30 working days, which may influence sequencing decisions depending on site availability and import readiness. The right path depends on the sponsor’s risk tolerance, funding timeline, and clinical endpoints.

    FAQ: Brazil’s ANVISA clock and first‑in‑human planning

    How long does ANVISA have to review key clinical trial petitions in Brazil?

    NIH ClinRegs summarizes that, under Law No. 14.874, ANVISA’s analysis of primary petitions for clinical trials (including DDCMs) must be completed within 90 business days.

    Does a 90-business-day regulator timeline guarantee fast first-patient-in?

    No. Activation speed depends on the entire system: ethics reviews, site contracts, import logistics, training, and operational readiness. A defined review window reduces uncertainty, but sponsors still need parallel planning.

    What is the biggest mistake sponsors make when planning first‑in‑human studies in Brazil?

    Treating regulatory submission as the whole project. The most common failure mode is not “regulatory delay”—it is downstream operational bottlenecks that were not designed into the timeline.

    Bottom line: Brazil’s defined review timeline can be a real advantage for early-stage programs, but only if sponsors plan activation as a coordinated set of parallel workstreams. If you treat the 90-day clock as a project management tool—not just a legal detail—you can reduce uncertainty and protect your first-patient-in date.

  • Anvisa’s 2026–2027 International Convergence Agenda: What Medtech Sponsors Need To Plan For

    ANVISA’s 2026–2027 International Convergence Agenda: What MedTech Sponsors Need to Plan For

    Brazil’s medical device regulator, ANVISA, is in the middle of the most aggressive period of international regulatory convergence in its history. Between the mid-2024 Brazilian Clinical Research Law (Lei 14.874) becoming fully operative on January 1, 2025, and the agency’s published 2026–2027 priorities, the rules around clinical trial submissions, post-market surveillance, software as a medical device (SaMD), and unique device identification (UDI) are all changing simultaneously.

    For MedTech sponsors planning to use Brazilian clinical data in US, EU, or Brazilian regulatory submissions, the next 18 months are a strategic window. Here is what is changing, why it matters, and how to plan for it.

    What Is Actually Changing

    Three convergence streams are running in parallel.

    1. Stronger international cooperation on device review. ANVISA has expanded its participation in international regulatory work-sharing arrangements, including the Medical Device Single Audit Program (MDSAP) and increased reliance agreements with FDA, EMA, and Health Canada-equivalent regulators. The practical effect: a device that has cleared review in a recognized reference jurisdiction can move through Brazilian registration substantially faster than under the old country-by-country framework.

    2. New SIUD database and UDI implementation. ANVISA’s Sistema de Informação de Identificação Única de Dispositivos Médicos (SIUD) is being phased in across 2026, requiring UDI assignment, labeling, and database submission for medical devices entering the Brazilian market. The phase-in follows risk class — Class IV (highest risk) and IVDs first, then descending through Class III, II, and I over the multi-year timeline.

    3. Software-as-a-medical-device pathway clarification. ANVISA has published updated normative instructions for SaMD classification, including AI-enabled clinical decision support, aligning more closely with FDA and IMDRF frameworks. For digital health and AI MedTech sponsors, the Brazilian pathway is now substantially more predictable than it was 24 months ago.

    All three streams are happening on top of the already-operative parallel review framework under Lei 14.874, which lets sponsors submit to ANVISA and the institutional ethics review system simultaneously rather than sequentially.

    Why the Window Matters Now

    For sponsors planning a Brazilian arm of a clinical trial — or a market access registration — three strategic implications flow from the current convergence wave.

    Documentation prepared for FDA or EU MDR is increasingly leverageable in Brazil. The technical file structure, risk classification reasoning, and clinical evidence summary you build for an FDA 510(k), De Novo, or EU MDR conformity assessment now translates more directly into ANVISA’s expectations than at any prior moment. The historical penalty of duplicating documentation across regions is materially smaller in 2026 than it was in 2022.

    The window for “first to file under the new framework” is open. Regulatory teams that align Brazilian submissions with the new convergence framework now will move ahead of teams that wait for further clarification. Once a sponsor has navigated one device through the new SIUD or updated SaMD pathway, every subsequent submission moves faster.

    Post-market obligations are being modernized. The new SIUD database is not just a labeling exercise — it forms the backbone of a more sophisticated post-market surveillance regime. Sponsors who structure their data capture and adverse event tracking systems to align with the new SIUD inputs from day one save significant retrofit cost later.

    Practical Planning for the Next 12 to 18 Months

    Three actions are appropriate for any sponsor with Brazilian exposure or plans:

    • Audit your UDI strategy now. If your device class is in the early SIUD phase-in, allocate budget and labeling capacity in 2026. If your device is in a later phase, use the next 12 months to harmonize UDI assignment with the FDA UDI database and the EU EUDAMED framework so all three jurisdictions are covered with a single system.
    • Restructure your technical file with convergence in mind. The 2026 reality is that one well-organized technical file should serve FDA, EU MDR, and ANVISA submissions with mostly mechanical translation steps and only modest jurisdiction-specific addenda. If your team is still maintaining three parallel files, the next 12 months are the right window to consolidate.
    • Engage early on SaMD classification. If your device incorporates software, AI, or clinical decision support, ANVISA’s updated framework means that a pre-submission classification conversation now yields meaningfully more predictable answers than two years ago. Take advantage of that predictability before launching the trial.

    Frequently Asked Questions

    Does the new ANVISA convergence framework affect clinical trial submission timelines?
    Yes — primarily through Lei 14.874’s parallel review mechanism, which lets ANVISA and ethics committees review submissions simultaneously instead of sequentially. The practical effect is a several-week to several-month reduction in start-up timelines compared with the pre-2025 framework, depending on device complexity.

    If my device is FDA-cleared, will ANVISA accept the FDA submission as-is?
    Not as-is. ANVISA’s reliance and convergence framework reduces duplication but does not eliminate the need for a Brazil-specific submission. What it does change is that your FDA-aligned technical file, risk classification logic, and clinical evidence package now translate more directly into ANVISA expectations, with smaller jurisdiction-specific gaps to fill.

    How does the SIUD database affect sponsors who do not yet sell in Brazil?
    If you have no Brazilian commercial presence and no plans for one, SIUD does not directly apply. If you are running a clinical trial in Brazil intending to commercialize there later — or to use Brazilian data in support of a future commercial registration — building UDI alignment into your trial-stage device labeling now is materially cheaper than retrofitting it later.

    bioaccess® supports first-in-human and early-feasibility medical device trials across 10 Latin American countries, including Brazil under ANVISA’s modernized framework. Learn more at bioaccessla.com or book a strategy conversation at bioaccessla.com/book-a-meeting.