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.