Author: Julio Martinez-Clark

Almost every first-in-human device sponsor I work with asks some version of the same question once the protocol starts taking shape: do we need a data monitoring committee, a clinical events committee, a medical monitor, or all three? Founders hear the acronyms from investors, from their FDA consultant and from the ethics committee, and they assume each one is a box to tick. In a 10- to 20-patient early study, buying all three can cost more than it protects. Leaving out the wrong one can stall the study the first time something goes wrong.

I am Julio Martinez-Clark, CEO of bioaccess®. This page explains what each of the three safety-oversight roles actually does in a first-in-human (FIH) or early feasibility device study, what FDA and Brazil’s ANVISA say about them, and how I size them for a small study in Latin America. It goes with our guide to stopping rules and staggered enrollment in an FIH device study, the ISO 14155 inspectable file and our early feasibility studies page. This is operator guidance, not legal or regulatory advice; check the current text of each regulation before you finalize your plan.

One-sentence answer

A medical monitor is the sponsor’s physician who reviews safety events as they happen, a clinical events committee (CEC) independently classifies events and endpoints against definitions written in advance, and a data monitoring committee (DMC, also called a DSMB) independently reviews the accumulating data and recommends whether the study should continue; a small FIH device study almost always needs the first, usually benefits from a lean version of the second, and needs the third when the risk analysis, the population or the regulator calls for it, which in Brazil includes every pivotal study of a Class III or IV device.

What each role does

Medical monitor

The medical monitor is a physician working for, or contracted by, the sponsor. They review serious adverse events as they come in, answer investigators’ protocol and eligibility questions, judge whether an event is a potential unanticipated adverse device effect, and make sure the reporting clocks start. They are not independent of the sponsor, and nobody expects them to be. Their value is speed: in an FIH study the first serious event usually needs a medical decision the same day.

Clinical events committee

A CEC is a small panel of independent physicians, often two or three specialists in the therapeutic area, who adjudicate events against definitions fixed in the protocol or a CEC charter before the first patient is enrolled. They decide whether an event meets the definition of a serious adverse event or a primary endpoint event, and whether it is related to the device, the procedure, or neither. They do not decide whether the study continues. Their output is consistency: the same event at two sites gets the same classification, and an investigator who is enthusiastic about the device is not the only person deciding whether it caused a complication.

Data monitoring committee

A DMC is a group of independent experts, typically clinicians plus a statistician and sometimes an ethicist, that reviews accumulating safety (and sometimes effectiveness) data at planned points and recommends to the sponsor whether to continue, modify or stop the study. FDA’s February 2024 draft guidance, Use of Data Monitoring Committees in Clinical Trials, which when finalized replaces the March 2006 guidance on establishing and operating DMCs, describes exactly this function. The DMC recommends; the sponsor decides and owns the consequences.

What FDA says

Under FDA regulations, sponsors are not required to use a DMC except in the narrow emergency-research setting of 21 CFR 50.24(a)(7)(iv). Device sponsors are, however, required to monitor their investigations under 21 CFR Part 812 (812.40 and 812.46), and unanticipated adverse device effects must be evaluated and reported within 10 working days under 21 CFR 812.150.

The tone has shifted. The 2006 guidance said DMCs were not needed for most studies, particularly early ones. The 2024 draft drops that language and notes that DMCs are now used in early-phase trials in serious diseases or conditions and where causality of adverse events is hard to judge without seeing the full data. FDA’s early feasibility study guidance (section 7.4.2) names a data monitoring committee of clinicians, scientific experts and people with ethics expertise as one possible risk-mitigation element for an early device study. Neither document makes a DMC mandatory for an FIH device study. Both make it something your reviewer may ask about.

What Brazil adds

ANVISA’s RDC 837 of 13 December 2023, which governs device clinical investigations in Brazil, is more specific. Under Art. 57 the sponsor must consider a DMC before the study starts, 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 decision. Art. 54 adds that the sponsor, or an independent DMC, evaluates adverse events in aggregate, and that evaluation feeds the annual reports.

So for an FIH study in Brazil, “we didn’t think about it” is not an available answer. You either have a DMC or a written justification for not having one.

ISO 14155:2020, the standard most Latin American ethics committees and regulators expect device sponsors to follow, treats a DMC as optional and expects the clinical investigation plan to say whether one is used and how it works. Ethics committees in the region read that section closely in first-in-human protocols.

How I size oversight for a small FIH study

1. Always name a medical monitor with a phone number the sites can reach on the day of the procedure. For a study run in Latin America, that person needs to be reachable in the sites’ time zone and comfortable reading source documents in Spanish or Portuguese.
2. Use a lean CEC when the endpoints involve judgment. If your primary safety endpoint is “major adverse events at 30 days” and relatedness to device versus procedure matters to your FDA story, two or three independent adjudicators with a short charter and pre-written definitions are usually worth it. If the endpoint is a simple, objective measurement, a CEC may add little.
3. Decide on the DMC against the risk file, not habit. Implantables, life-sustaining devices, fragile populations, follow-up longer than a few months, or a Brazilian pivotal Class III/IV study point toward a DMC. A short, single-country study of a low-risk procedure with staged enrollment may be well served by an independent safety reviewer instead, with the reasoning written into the plan.
4. Combine roles carefully in very small studies. In a 10-patient study, one small independent committee can sometimes adjudicate events and also make continuation recommendations, as long as its charter says so, its members have no financial stake in the device, and investigators do not vote on their own restart.
5. Write the charter before first patient in. Membership, conflicts of interest, meeting triggers (for example, after each of the first few subjects and after any serious event), what data the committee sees, how recommendations reach the sponsor, and who tells the ethics committee and regulator.

Common mistakes I see

• A DMC charter that exists on paper but whose first meeting is scheduled after the last subject is treated.
• The sponsor’s chief medical officer sitting on the “independent” committee.
• Event definitions that differ between the protocol, the CEC charter and the case report forms, so the adjudicators are classifying against a moving target.
• No plan for who translates source documents for an adjudicator who does not read Spanish or Portuguese.
• Treating the DMC’s recommendation as the regulatory report. In Brazil the sponsor still has to file it with ANVISA; in a US-bound program the sponsor still owns 812.150 reporting.

How bioaccess® runs this

In the first-in-human and early feasibility studies we run in Latin America, we set up the medical monitoring, the adjudication workflow and, where needed, the DMC charter as part of study start-up, and we map each committee’s output to the reporting clocks of every regulator involved: ANVISA, INVIMA, COFEPRIS, Panama’s MINSA, and FDA when the data will support a US submission. The goal is an oversight structure sized to a 10- to 30-patient study that still reads as rigorous to an FDA reviewer looking back at it.

FAQ

Is a DMC the same as a DSMB?

Yes. FDA’s guidance treats data monitoring committee, data and safety monitoring board (DSMB), data and safety monitoring committee and independent data monitoring committee as names for the same function.

Does FDA require a DMC for an early feasibility device study?

No. FDA does not require one outside the emergency-research exception in 21 CFR 50.24. Its early feasibility guidance lists a DMC as one possible risk-mitigation element, and reviewers may ask how you will oversee safety if you do not have one.

Does Brazil require a DMC?

For pivotal studies of Class III and IV devices, yes (RDC 837/2023, Art. 57). For other studies the sponsor must consider one based on its risk analysis and justify the decision in the clinical investigation plan if it does not set one up.

Can the CEC and DMC be the same people?

In a very small study, sometimes, if the charter defines both functions and the members are independent of the sponsor and the investigators. In larger studies they are usually kept separate.

Who pays the committee members?

The sponsor, under written agreements that disclose fees and conflicts of interest. Payment does not compromise independence as long as it is fixed and not tied to the study’s outcome.

Sources: FDA, Use of Data Monitoring Committees in Clinical Trials, draft guidance (February 2024) and Federal Register notice 2024-02849; FDA, Establishment and Operation of Clinical Trial Data Monitoring Committees (March 2006); FDA, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, section 7.4.2; 21 CFR 50.24, 812.40, 812.46 and 812.150; ANVISA RDC 837/2023, Arts. 54 and 57; ISO 14155:2020.

By Julio G. Martinez-Clark

CEO, bioaccess®

General information, not legal or regulatory advice. Review clocks are cited to the regulation or the regulator’s own guidance. Durations marked “bioaccess® experience” are planning estimates from our recent study timelines, not legal deadlines or guarantees. bioaccess® runs studies in all three regions, so this guide sets out the trade-offs rather than a single answer. Sources last checked: 29 October 2026.

In this guide: The short answer · Review clocks at a glance · Side-by-side comparison · United States · Canada · Latin America · Will FDA accept the data? · Decision guide · Hybrid plans · Questions to answer · Glossary · FAQ

The short answer

There is no single best region. The right choice depends on what the first study has to do for your program.

• The United States fits when you want FDA to shape the study with you from the start, when US investigators matter for the next study, or when investors want US data. FDA’s review clock is 30 days for both an IND (drugs) and an IDE (devices). The time usually goes into the pre-submission work, institutional review and contracts around it.
• Canada fits drug studies that want a 30-day default review (the trial is authorized if Health Canada does not object within 30 days), and device studies that can work with a 30-day review target, where the authorization for Class III and IV devices can be issued before ethics approval. Canada is also on FDA’s lists of countries with simplified export of investigational products.
• Latin America fits when activation speed, patient access and cost are the binding constraints, and when the study is designed from day one so FDA can accept the data. The regulator clock and review order vary by country: from parallel ethics and regulator review timed to each committee’s meeting schedule (Panama), to several months for drug trials where the regulator clock is long (Brazil: ANVISA 90 business days) or starts after ethics (Colombia: INVIMA 60 business days).

Many programs use more than one region in sequence. The data rules below decide whether that works.

Review clocks at a glance

The chart shows different published review milestones, not comparable approval or activation durations: the IND clock starts at FDA receipt, the CTA at receipt of a complete application, the ITA at the start of screening, and Colombia’s is a first response after ethics. Panama includes ethics review (up to 20 business days, 10 expedited, or 30 in total for full-committee review). It is not the time to first patient. Business days are converted to calendar days at about 7 calendar days per 5 business days, before holidays.

Side by side: US, Canada and Latin America

Question	United States	Canada	Latin America
Drug application	IND to FDA	Clinical Trial Application (CTA) to Health Canada	National regulator application; varies by country
Device application	IDE to FDA for significant-risk devices; non-significant-risk studies follow abbreviated IDE requirements with IRB approval	Investigational Testing Authorization (ITA) for unlicensed Class II, III and IV devices; none for Class I	Varies by country; confirm with us
Regulator clock	IND takes effect after 30 days unless FDA places a clinical hold; an IDE study may begin after 30 days unless FDA objects (21 CFR 312.40; 21 CFR 812.30)	CTA: 30-day default; ITA: 30-day target (CTA guidance; ITA guidance)	About 4 weeks (Panama) to about 4 months (Brazil, drug dossiers); see the table below
What happens if the regulator says nothing	IND takes effect after 30 days unless FDA places a clinical hold	CTA: authorized if no objection within 30 days. ITA: no automatic authorization	Depends on the country
Ethics review	IRB at each site, or a central IRB	Research Ethics Board (REB) per site	Ethics committee per site or national committee; order varies
Ethics and regulator in parallel?	Yes; IRB and FDA run separately	Yes. For Class III and IV devices, the ITA letter can issue before REB approval	Parallel in some countries (Panama; El Salvador (bioaccess® experience); Brazil submissions); sequential in others
Local presence needed	FDA states that the sponsor of an IDE must be located in the US	CTA attestation by a senior medical or scientific officer residing in Canada	Varies by country; an importer of record is needed for the product. Confirm with us
Regulator fee	Confirm with us	CTAs and ITAs carry no Health Canada fee	Varies; confirm with us
Labels	US investigational labeling	Drugs and devices: investigational statements in English and French	Local-language labels in several countries (for example Spanish in Panama and Chile)
Export from the US	Not needed	Simplified: Canada is on FDA’s tier-one list for devices and on the listed countries in 21 CFR 312.110(b) for drugs	Devices need FDA export approval under 801(e)(2); drugs ship under an IND in effect or, subject to its conditions, an export certification (21 CFR 312.110)
FDA use of the data	Collected under the IND or IDE	Foreign data: 312.120 (drug studies not conducted under an IND) and 812.28 (devices)	Same as Canada

United States: IND, IDE and early feasibility studies

Drugs. An IND goes into effect 30 days after FDA receives it, unless FDA places the study on clinical hold, or earlier if FDA says so (21 CFR 312.40). FDA offers pre-IND meetings before the filing.

Devices. For a significant-risk device, the study can begin 30 days after FDA receives the IDE unless FDA objects, or when FDA approves it by order. FDA can approve, approve with modifications, or disapprove (21 CFR 812.30). Non-significant-risk device studies follow abbreviated requirements with IRB approval (21 CFR 812.2(b)). See IDE vs IND, what to send in a Q-Submission and IDE steps after you submit.

Early feasibility studies (EFS). An EFS is a small, early device study, typically before the design is final, used to check the concept and guide changes. FDA’s EFS Program offers interactive review, help from an EFS representative, potentially less non-clinical data when clinical risk mitigations are in place, and faster ways to change the device or protocol. FDA recommends a Pre-Submission before the IDE (FDA EFS Program; 2013 guidance on IDEs for early feasibility studies, including certain first-in-human studies).

Where the US time goes. The 30-day clock is often not the longest step. Pre-submission meetings, approval-with-modifications rounds, institutional review, hospital contracts and clinical-trial insurance add the time. Across regions, an industry benchmark found an average of 31.4 weeks from site identification to completed start-up, with repeat sites 9.9 weeks faster (Tufts CSDD, 2018).

Canada: CTA and ITA

Drugs (CTA). A sponsor needs a Clinical Trial Application to sell or import a drug for a phase I to III trial. Health Canada has 30 days from receipt of a complete application to object; without an objection the trial is authorized, and Health Canada typically issues a No Objection Letter. Answers to questions during review are due within 2 calendar days (CTA guidance).

The 7-day review is narrower than many sources suggest. Health Canada’s 7-day administrative target applies only to comparative bioavailability studies of pharmaceuticals: single dose, healthy adults, a reference product marketed in Canada, the US or a few other listed countries, and a study dose no higher than the reference product’s labeled maximum. It does not apply to biologics, cell or gene therapies, or to other studies such as first-in-human studies of a new drug, which follow the 30-day default (CTA guidance, 2.3.3; performance standards).

Devices (ITA). Unlicensed Class II, III and IV devices need an Investigational Testing Authorization; Class I devices do not. The review target is 30 calendar days from the start of screening. It is a target, not a default: there is no automatic authorization. Screening deficiencies must be fixed within 15 calendar days. If Health Canada asks for more information after review, the applicant has 60 days to answer and a new 30-day review starts. The manufacturer or importer applies. For Class III and IV devices, the Letter of Authorization can be issued before REB approval, as long as at least one qualified investigator is named; REB approval must reach Health Canada before the study starts. ITA applications carry no fee, and pre-ITA meetings are available (ITA guidance).

Practical points. Drug labels must carry the required information in English and French, and device labels need the investigational statements in both languages. The CTA must be attested by a senior medical or scientific officer residing in Canada. Our Canada page compares Canada and Latin America for first-in-human device trials.

Latin America: regulators and review order

Latin America is not one pathway. The order of ethics and regulator review is the biggest difference between countries. These are the published clocks; our site activation guide has the full country notes and sources.

Country	Regulator	Order	Published clock
Panama	MINSA; DNFD for medicines and health products	Ethics and ministry in parallel	Ethics up to 20 business days (10 expedited; 30 in total if the full committee reviews); DNFD 15 business days (Executive Decree 21 of 2026)
El Salvador	SRS with the national ethics committee (CNEIS)	One submission, parallel review (bioaccess® experience)	No published clock; about 47 to 85 days to approval (bioaccess® experience)
Costa Rica	CONIS	Accredited ethics committee first, then CONIS registration	CONIS acknowledges a complete registration within 5 business days; technical report within 10 business days
Brazil	ANVISA	Can be submitted in parallel; drug trials start after both approve	ANVISA 90 business days for drug dossiers (RDC 945/2024); ethics 10 working days to check plus 30 days (Law 14,874)
Colombia	INVIMA	Ethics first, then INVIMA	First INVIMA response within 60 business days for drug protocols (INVIMA guide GU039)
Mexico	COFEPRIS	Institutional committees first, then COFEPRIS	30 business days under the health research regulation (COFEPRIS guidance states 30 calendar days; confirm with us)
Argentina	ANMAT	Confirm with us	Drug studies: 20 + 10 or 35 + 10 business days of technical and administrative review (Disposition 7516/2025)
Chile	ISP	Ethics report and ISP authorization for drug trials	45-day term, average evaluation 28 business days, reported by InvestChile
Ecuador	ARCSA	Ethics committee (CEISH) first, then ARCSA	Document check in 7 days, then up to 60 days of technical review (extendable by 30)
Peru	INS	Ethics first, then INS	Up to 30 working days

bioaccess® runs first-in-human studies in Colombia now.

In our recent plans, the quickest-review countries reached first patient about 8 to 9 months from a protocol synopsis, or about 4.5 to 6 months from a final protocol (bioaccess® experience). Ethics committee calendars and turnaround are practice, not law, and they vary by committee.

Will FDA accept data from outside the US?

Yes, when the study is designed and run for it. It is never automatic.

• Drugs. FDA accepts a well-designed, well-conducted foreign study not run under an IND if it followed good clinical practice, including independent ethics committee review and informed consent, and FDA can validate the data through an onsite inspection if needed. The sponsor describes the steps taken to meet GCP (21 CFR 312.120). Approval based only on foreign data is governed separately (21 CFR 314.106).
• Devices. For investigations that began on or after 21 February 2019, FDA accepts data from outside the US to support an IDE, 510(k), De Novo or PMA if the investigation is well designed and conducted, a GCP statement and the supporting information are provided, and FDA can validate the data (21 CFR 812.28). FDA notes that an IDE is not needed for a study conducted entirely at foreign sites, but FDA decides whether to accept the data (FDA).
• Canada and Latin America are treated the same way. For FDA, both are foreign data. What matters is how the study was run, not the country.

Design rules that protect acceptance: follow ISO 14155 for devices and ICH GCP for drugs, use an independent ethics committee, keep source documents and device accountability inspection-ready, and show FDA your plan in a pre-submission meeting before the study starts. More detail: Panama and El Salvador data for an FDA IDE, 510(k) or De Novo.

Decision guide: which region fits your program

If your priority is…	Consider	Why
Iterating the device with FDA from the first case	United States (EFS)	FDA’s EFS Program is built for interactive review and fast design changes
US investigators who will run the pivotal study	United States	Early experience stays with US sites
A 30-day default drug review	Canada	30-day CTA default, separate REB review
A device authorization that does not wait for ethics approval	Canada	Class III and IV ITA letters can issue before REB approval
A simplified export from the US	Canada	Tier-one country for FDA device export; listed country in 21 CFR 312.110(b) for drugs
Short review where ethics and regulator run in parallel	Latin America (for example Panama; El Salvador (bioaccess® experience))	Parallel ethics and regulator review
Patient access and enrollment throughput	Latin America	Depends on the indication and the site; confirm with feasibility
Lower study cost	Compare study-specific budgets in each region	In our studies Latin American site costs have been lower than US costs (bioaccess® experience); see our line-by-line budget guide
Data that must support an FDA submission	Any region	In the US, run under the IND or IDE; outside the US, design for 312.120 or 812.28 from day one

Hybrid plans

Common sequences in our practice:

1. Latin America first-in-human, then a US EFS or feasibility study. First human data before the US study; FDA sees the plan in a pre-submission.
2. A US EFS with a parallel cohort in Canada or Latin America. US FDA interaction plus enrollment from other sites under one protocol.
3. Canada for a drug phase 1, then Latin American and US sites for phase 2.

For cardiovascular devices, our sister organization Amavita Research runs a site in Miami, so one team can coordinate a US arm and a Latin American arm. See also US vs Latin America for first-in-human.

Questions to answer before you choose

• Which FDA submission will this study support, and has FDA seen the plan?
• Is the product used in the study identical to the one you will file, or do you need a documented comparison?
• Who is the sponsor of record in each country, and who is the importer of record?
• Which ethics committees review, how often do they meet, and in what language do they want the file?
• Can the sites’ source documents and accountability logs pass an FDA inspection?
• Do the sites see enough of your patients, and can they keep them through follow-up?
• What is the export route from the US for your product?

Glossary

• IND: Investigational New Drug application to FDA.
• IDE: Investigational Device Exemption from FDA, for significant-risk device studies.
• EFS: early feasibility study; a small, early device study, often first-in-human.
• Q-Submission (Pre-Sub): a request for FDA feedback before a submission.
• CTA: Clinical Trial Application to Health Canada (drugs).
• NOL: No Objection Letter from Health Canada.
• ITA: Investigational Testing Authorization from Health Canada (devices).
• REB / IRB / ethics committee: the independent committee that reviews the study for participant protection.
• GCP: good clinical practice (ICH E6 for drugs, ISO 14155 for devices).
• Tier-one country: FDA’s short list of countries with simplified export of investigational devices; a similar country list applies to drugs in 21 CFR 312.110(b). No Latin American country is on either list.

Frequently asked questions

Is Canada’s CTA review really 7 days for phase 1?
Only for comparative bioavailability studies of pharmaceuticals in healthy adults that meet Health Canada’s criteria. A first-in-human study of a new drug follows the 30-day default review.

How long does FDA take to review an IND or IDE?
30 days from receipt. An IND takes effect after 30 days unless FDA places a clinical hold; an IDE study may begin after 30 days unless FDA objects, or earlier if FDA approves it by order.

Does Health Canada’s ITA authorize a device automatically after 30 days?
No. The 30 days is a review target, not a default. Health Canada issues a Letter of Authorization when the application meets the requirements.

Do I need an IDE to run a device study only in Latin America or Canada?
FDA says an IDE is not needed for a study conducted entirely at foreign sites. You still need the local approvals, and FDA evaluates the data under 812.28 when you submit it.

Will FDA accept first-in-human data from Latin America or Canada?
It can, when the study meets 21 CFR 312.120 (foreign drug studies not conducted under an IND) or 812.28 (devices): good clinical practice, independent ethics review, consent and data FDA can validate. Acceptance is decided per submission.

Which region is fastest to first patient?
It depends on the country and the study. FDA’s IND and IDE clocks are 30 days; Health Canada’s CTA has a 30-day default and the ITA a 30-calendar-day target from the start of screening, with no automatic authorization. In Latin America, published clocks range from about 4 weeks (Panama, parallel review) to several months where clocks are long or sequential. In our recent plans, the quickest-review Latin American countries reached first patient about 4.5 to 6 months from a final protocol (bioaccess® experience).

Which region is cheapest?
It depends on the study, the procedure and the sites, so compare study-specific budgets. In our studies, Latin American site costs have been lower than US costs (bioaccess® experience). See our sample budget.

Can I combine regions?
Yes. Some programs run a first-in-human cohort in one region and the next study in another, or a parallel cohort under one protocol. One regulatory strategy should cover all the regions.

What does Canada require that the US does not?
English and French label statements, and a CTA attestation by a senior medical or scientific officer residing in Canada.

Are these clocks calendar days or business days?
FDA and Health Canada clocks are calendar days. Most Latin American clocks are business days, so 30 business days is about 6 weeks on the calendar before holidays. The country table says which unit each clock uses.

Talk through your plan

Send us your synopsis and the FDA submission you are aiming for. We will tell you which regions and countries fit, and which don’t. Contact bioaccess®.

Related reading: Site activation timeline in Latin America · Importing investigational drugs and devices into Latin America · IDE vs IND · FDA Q-Submission · FDA IDE steps after you submit · Panama and El Salvador data for FDA · US vs Latin America for first-in-human · Canada vs Latin America for device trials · Clinical trial budget by country, line by line

Sources

• FDA: 21 CFR 312.40; 21 CFR 312.120; 21 CFR 812.2; 21 CFR 812.28; 21 CFR 812.30; EFS Program; Import and export of investigational devices
• Health Canada: CTA guidance; Performance standards; ITA guidance
• Latin America: country sources in our site activation guide
• Tufts CSDD site start-up benchmark (2018), as reported in Tufts CSDD’s release

When a US or European manufacturer asks me who should hold its ANVISA registration in Brazil, the conversation usually centers on dossiers and timelines. The question I push onto the table early is a different one: when something goes wrong with a device that is already on the Brazilian market, who has to act, and how fast? In Brazil the answer is written into one resolution, and it lands squarely on the registration holder.

I am Julio Martinez-Clark, CEO of bioaccess®. This page explains what ANVISA’s RDC 551/2021 requires of a registration holder when a marketed medical device needs a field action (a recall, a correction, or a safety alert), and what that means for how you set up your holder in Brazil. It sits next to our Brazil ANVISA market-access page, the guide to the LATAM registration holder and importer of record and the guide to transferring a registration to a new holder. This is operator guidance, not legal advice. Check the current text of the resolution and ANVISA’s forms before you act on a live event.

One-sentence answer

Under ANVISA RDC 551/2021, the Brazilian registration holder must start a field action as soon as there is sufficient evidence that a marketed device does not meet its essential safety and performance requirements, notify ANVISA within 3, 10 or 30 calendar days of deciding to act depending on the risk, get ANVISA’s prior approval within 5 calendar days for any alert that runs in mass media, issue a clear alert message, file monitoring and closure reports, and keep a traceable file of the whole action.

Who is responsible: the holder, not the foreign factory

RDC 551 was published on 30 August 2021 and took effect on 1 October 2021. It replaced RDC 23/2012 (Art. 19). Article 2 defines the detentor de registro as the company that holds the registration or notification of the product with ANVISA. That is the legal person in Brazil, not the manufacturer abroad.

The same article makes the holder and every other party from production to use (or disposal) jointly responsible for keeping the product’s quality, safety and effectiveness up to the end user. In practice ANVISA addresses the holder. If your distributor holds your registration, your distributor is the company ANVISA expects to plan, notify and run your recall in Brazil. That is one more reason I tell manufacturers to think hard before they let a commercial partner hold the registration.

What counts as a field action

Article 3 defines a field action (ação de campo) as an action by the manufacturer or registration holder that aims to reduce the risk of an adverse event related to a device that has already been marketed. It also defines:

• Alert message: the holder’s communication to health professionals, patients, users and others about the risk of an adverse event.
• Serious adverse event: death; permanent damage to a body structure; medical or surgical intervention to prevent permanent impairment; hospitalization or prolonged hospitalization; or fetal distress, fetal death or congenital anomaly.
• Serious threat to public health: any occurrence that creates an imminent risk of death, serious injury or serious illness and calls for rapid corrective action.

Article 4 sets the trigger. The holder must start a field action as quickly as possible whenever there is sufficient evidence, or proof, that a device does not meet its applicable essential safety and effectiveness requirements. The holder is also the one who has to say whether marketing or importation of the affected lot or series must be suspended, unless the national health surveillance system decides it first (Art. 4, §2). Article 6 adds that the system can order a field action on its own, whatever the holder has or hasn’t done.

The clocks

All of the deadlines below are in calendar days, and they run from the decision to carry out the field action (Art. 8 and Art. 9, §1), not from the date the complaint arrived. That makes the date you document the decision important.

Situation	Deadline to notify ANVISA	Basis
The alert must run in mass-circulation media	3 calendar days (plus prior approval of the message within 5 calendar days)	Art. 9, I; Art. 8
Serious threat to public health	3 calendar days	Art. 9, II
Risk of a serious adverse event (not covered above)	10 calendar days	Art. 9, III
Any other field action	30 calendar days	Art. 9, IV

Notification goes in on ANVISA’s specific form (Art. 9, §2), and ANVISA can ask the holder to revise or complete it (Art. 9, §3). ANVISA’s instructions for the form say the notification form and the distribution map must be attached to the initial field-action petition. When the affected device has been implanted, the holder must also attach a follow-up plan for implanted patients covering, at a minimum, the patient list, how and how often patients will be contacted, what data will be collected and analyzed, what measures follow from the results, and how the plan’s effectiveness will be assessed.

Mass-media alerts need ANVISA’s approval first

If the alert has to go out through mass-circulation media, the holder must submit the message for ANVISA’s prior approval within 5 calendar days of the decision, under Art. 41-B of Law 9.782/1999 (Art. 8). ANVISA can approve it or point out corrections. Once approved, the holder must run it immediately. Prior approval does not replace the Art. 9 notification; both are required (Art. 8, §4).

What the alert message must say

Article 7 requires the holder to issue the alert as quickly as possible, in clear and objective language, with at least:

1. the problem;
2. the product: registration or notification number, product name, model and affected lot or serial numbers;
3. the risk the problem creates;
4. instructions for health professionals, patients, users and anyone else concerned.

The holder picks the most effective channel. For a hospital-only device that is usually direct letters to the risk managers of the hospitals on the distribution map. For a widely used product it may mean media, which brings in the Art. 8 approval step.

After the notification

• Monitoring and closure reports go to ANVISA on the dates the holder declared in the action plan, on ANVISA’s model, with proof of completion (or a statement that the proof is on file) attached to the closure report (Art. 10). ANVISA can ask for reports on other dates (Art. 11).
• Distributors must send the holder the distribution map and any other information needed, in good time (Art. 12). Put this obligation in your distribution agreements; a holder that can’t get a distribution map can’t meet a 3-day clock.
• Patient and user assistance is mandatory when the device has been or is still being used, to bring the risk to an acceptable level and reduce harm already done (Art. 13).
• Recalled product must be identified and segregated in a separate, secure area until its final destination is decided; if nothing is collected, the affected product still has to be identified and, where relevant, segregated (Art. 14). Destruction is the holder’s responsibility and must fully de-characterize the product (Art. 15).
• Records: the holder keeps an up-to-date, traceable file of every field action, including proof of correspondence sent and received and proof of completion (Art. 16).
• Written procedures for field actions are mandatory (Art. 5). ANVISA will ask for them, and an auditor will too.

Breaking these rules is a health infraction under Law 6.437/1977, without prejudice to civil, administrative and criminal liability, including under the Consumer Defense Code, Law 8.078/1990 (Art. 17).

A global recall usually becomes a Brazilian field action

The resolution doesn’t care where the problem was found. If your headquarters opens a recall or field safety corrective action in the US or Europe and the affected models or lots were shipped to Brazil, your Brazilian holder has to decide on a field action there and the clocks start from that decision. The coordination failure I see most often is a global quality team that issues its field safety notice and only tells the Brazilian holder days later. By then the 3- or 10-day window may already be closing.

How I set this up for a foreign manufacturer

1. Write the field-action SOP before launch, not after the first complaint (Art. 5). It names who in Brazil decides, who files, and how the decision date is recorded.
2. Wire the global quality system to the holder. The manufacturer’s complaint, CAPA and recall procedures should name the Brazilian holder as a party that is notified the same day a field action is considered for any lot shipped to Brazil.
3. Keep the distribution map current. Contract distributors to deliver it on demand (Art. 12), down to lot and serial number for implants.
4. Prepare the Portuguese alert template with the four Art. 7 elements, ready to fill in.
5. Plan for implants. If you sell implantable devices, draft the patient follow-up plan structure in advance; ANVISA’s form instructions ask for it with the initial notification.

That is what a registration holder is for. At bioaccess® we provide an independent ANVISA registration holder service for foreign manufacturers, so the company answering to ANVISA on a field action is not the same company that sells your product. Pricing is two-part, a one-time registration fee plus an annual holder fee, as set out on our market-access page.

FAQ

Does RDC 551 apply to devices under notification as well as registration?

Yes. Article 2 defines the holder as the company that holds the registration or the notification of the product with ANVISA, so lower-risk notified devices are covered too.

When does the 10-day clock start?

From the decision to carry out the field action (Art. 9, §1). Document that decision with a date.

Can the distributor run the recall?

Distributors must supply the distribution map and information on time (Art. 12), but notification and the action itself are the holder’s obligations. If your distributor is also your holder, it runs your recall.

What did RDC 551 replace?

RDC 23/2012 and RDC 501/2021 (Art. 19). RDC 551 took effect on 1 October 2021 (Art. 20).

Sources: ANVISA RDC 551, of 30 August 2021 (DOU), Arts. 1 to 20; ANVISA field-action page and the instructions for completing the field-action notification form.