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:
- the problem;
- the product: registration or notification number, product name, model and affected lot or serial numbers;
- the risk the problem creates;
- 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
- 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.
- 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.
- Keep the distribution map current. Contract distributors to deliver it on demand (Art. 12), down to lot and serial number for implants.
- Prepare the Portuguese alert template with the four Art. 7 elements, ready to fill in.
- 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.