How to report an adverse event to ANVISA (Notivisa)
Reporting an adverse event to ANVISA (Brazil's health regulatory agency) means telling the health surveillance system that a controlled product, such as a filler, a toxin or an anesthetic, was associated with a problem. It is what lets the agency pool isolated cases, spot a defective lot, issue alerts and, if necessary, recall products. In orofacial harmonization (HOF), where a good share of the products are high risk and many uses are off-label, reporting is part of patient care and of your documentation.
The most common doubt is not whether to report, but where. ANVISA uses more than one system, and the channel changes with the type of product and the type of problem. Channels checked on the official ANVISA and gov.br pages on October 20, 2026. Screens and system flows change: before reporting, check ANVISA's notifications page.
Adverse event or technical complaint?
These are two different categories, and the choice changes the form.
| Category | What it is | Examples in HOF |
|---|---|---|
| Adverse event | Harm or an unwanted effect on the patient's health, associated with use of the product | Vascular occlusion and necrosis, hypersensitivity reaction, granuloma, eyelid ptosis after toxin, infection |
| Technical complaint | Suspected quality deviation in the product, with or without harm | Leaking syringe, gel with altered appearance, particles, vial without vacuum, illegible label, tampered packaging, suspected counterfeiting, unexpected lack of effect with a suspected lot |
The same case can have both sides. Hypothetical example: a lot of filler with a cloudy appearance, injected before anyone noticed, followed by inflammatory nodules in several patients. There is a technical complaint (the product) and adverse events (the patients).
Which system should you use for each product?
The point that confuses most: drugs and medical devices follow different paths. Botulinum toxin, registered hyaluronidase and anesthetics are drugs. Fillers, injectable biostimulators, threads, cannulas and needles are medical devices; fillers sit in the highest risk classes, as explained in class IV medical device.
| Product | Adverse event | Technical complaint |
|---|---|---|
| Drugs (botulinum toxin, anesthetics, registered hyaluronidase) | VigiMed | Notivisa |
| Medical devices (hyaluronic acid, biostimulators, threads, cannulas, needles) | Notivisa | Notivisa |
| Cosmetics used before or after (dermocosmetics, sunscreens) | Notivisa | Notivisa |
| Citizen report about devices and cosmetics | e-Notivisa | e-Notivisa |
| Citizen report about a drug | VigiMed form | ANVISA channels for citizens |
A summary of the three channels:
- VigiMed: ANVISA's system for adverse events from drugs and vaccines. It has an electronic form for citizens and health professionals and an access point for registered professionals and institutions.
- Notivisa: system for adverse events and technical complaints about the other products under health surveillance, including medical devices and cosmetics, and for technical complaints about drugs. It requires registration and login. There is a profile for independent health professionals not tied to a registered institution.
- e-Notivisa: a service for anyone to report problems with medical devices, cosmetics, food and sanitizing products, with a silver- or gold-level gov.br account. The complaint is forwarded to the manufacturer or distributor and can be tracked in the system.
Is reporting mandatory for an HOF practice?
It depends on how the service is classified. ANVISA's RDC 36/2013, on patient safety, applies to health services and requires a Patient Safety Center (Núcleo de Segurança do Paciente), which reports adverse events monthly, by the 15th business day of the following month, and within 72 hours when the event progresses to death. The sole paragraph of art. 2, however, excludes individual practices from its scope.
In practice:
- A clinic structured as a health service (staff, several treatment rooms, a health license as an establishment) tends to fall under RDC 36/2013 and needs to organize a reporting flow.
- An individual practice falls outside that resolution, but reporting remains possible and recommended, and other rules, from the professional council and the local surveillance authority, may require complications to be communicated.
Confirm with your city's health surveillance authority and with your professional council which category your service is in. If you share a room or rent hours in a clinic, you should know whether the service has a safety center and who reports; see ANVISA RDCs for the HOF clinic.
What should you report in HOF routine?
There is no closed list, but some cases justify reporting more clearly:
- Serious event: vascular occlusion with necrosis, visual complication, anaphylaxis, hospitalization.
- Unexpected event: a reaction not listed on the label or in the instructions for use, or occurring more often than expected.
- Repetition: more than one patient with the same picture after the same lot.
- Suspicion about the product: altered appearance, lack of effect with a suspected lot, tampered packaging, cold chain broken in transport.
Expected, mild complications, such as swelling and small bruises, generally do not need reporting, but they should be in the patient record. When in doubt about a serious event, report: surveillance works with suspicions, not certainties.
What data should you gather before reporting?
The more complete the report, the more useful it is. Gather:
| Group | Data |
|---|---|
| Product | Trade name, manufacturer, ANVISA registration number, lot, expiry date, supplier and invoice |
| Use | Date and time, area treated, amount injected, technique in general terms, whether use was on-label or off-label |
| Patient | Initials, age, sex, relevant comorbidities and medications, without data that is not needed |
| Event | Onset of signs, description, severity, management adopted, course and known outcome |
| Evidence | Dated clinical photos, kept in the patient record, and the remaining product set aside and labeled |
| Reporter | Your name, professional council and contact, for any follow-up from surveillance |
This work becomes simple when injectable traceability is already routine: a label or note of the lot in the patient record at each injection. There is a template for lot recording and traceability with a field for the report protocol number.
Step by step, at review level
- Treat first. Reporting never delays management. Follow the complication protocol and refer when indicated.
- Record in the patient record. Times, signs, management, medications with lot numbers, photos and instructions given.
- Classify. Adverse event, technical complaint or both. Drug or device.
- Choose the channel. VigiMed for a drug's adverse event; Notivisa for devices, cosmetics and technical complaints.
- Fill in with objective data. Describe what was observed, without conclusions you do not yet have.
- Keep the receipt. Protocol number, date and a copy of what was sent, attached to the patient record.
- Notify the manufacturer. The registration holder also has surveillance obligations and may investigate the lot. Notifying the manufacturer does not replace reporting to ANVISA.
- Follow alerts. ANVISA publishes alerts and recalls; it is worth checking whether the lot appears.
What about patient data?
A report involves health data, which is sensitive personal data under the LGPD (Brazil's data protection law). Provide only what surveillance needs, use initials when the form allows and do not send photos of the patient's face to the manufacturer or supplier without a legal basis and authorization. The full record, with identification, stays in the patient record. The informed consent can mention that adverse events may be reported to health authorities, which makes the patient aware from the start.
How do you talk to the patient about the report?
Explaining it this way usually reduces mistrust and shows care. Promising what ANVISA will do with the report, on the other hand, is not advisable: the agency's response is not guaranteed and has no deadline for the professional.
And in Harmy?
Reporting checklist
- Patient treated and referred when indicated.
- Patient record with times, photos, management and lot.
- Classification done: adverse event, technical complaint or both.
- Right channel: VigiMed (drug) or Notivisa (device, cosmetic, technical complaint).
- Remaining product set aside and labeled.
- Report protocol attached to the patient record.
- Manufacturer notified.
- Service classification under RDC 36/2013 confirmed with local surveillance.
For the practice's emergency plan as a whole, see the HOF practice emergency kit.
Frequently asked questions
How do I report an adverse event to ANVISA?
It depends on the product. Adverse events from drugs and vaccines, such as botulinum toxin, go to VigiMed. Adverse events and technical complaints about medical devices, such as fillers, and technical complaints about drugs go through Notivisa. Citizens can also report problems with devices and cosmetics through e-Notivisa, with a gov.br account.
What is the difference between an adverse event and a technical complaint?
An adverse event is harm or an unwanted effect on the patient's health associated with use of the product. A technical complaint is a suspected problem with the product itself, such as a defect, a change in appearance, tampered packaging, an irregular label or suspected counterfeiting, even without harm to the patient.
Can a self-employed professional report through Notivisa?
Yes. Notivisa has a profile for independent health professionals, for those not tied to a registered institution, and access requires prior registration. For drugs, VigiMed offers an electronic form for citizens and health professionals.
Is reporting adverse events mandatory for a harmonization clinic?
RDC 36/2013 requires health services to report adverse events through the Patient Safety Center (Núcleo de Segurança do Paciente), but it excludes individual practices from its scope. Even when there is no formal obligation, reporting is recommended and helps surveillance detect problems with products. Confirm how your service is classified with the local health surveillance authority.
Does reporting to ANVISA mean admitting fault?
No. Reporting serves product and care surveillance: it gathers risk signals and can lead to alerts, lot investigations and recalls. It is not a proceeding against the professional and does not replace the entry in the patient record.
Harmy images are illustrative simulations generated by AI from the patient's photo to support the conversation between practitioner and patient. They are not a promise of results. Indication, technique, product and volume are solely the decision of the licensed practitioner. This content is for information only and does not replace a clinical assessment.