ANVISA: what it is and its role in facial harmonization
Quick facts
- Definition
- Brazil's National Health Surveillance Agency, a federal health body.
- Role
- Regulates and oversees products, services and facilities subject to health surveillance.
- In facial harmonization
- Registers and controls products such as dermal fillers and toxins.
- For the professional
- Check the registration, lot and expiration date of the product being applied.
- Does not
- Does not define which professionals may inject, a matter for the professional councils.
ANVISA is Brazil's National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária), a federal government body linked to health. It regulates and oversees products and services that may affect health, from medicines to equipment, including the products used in aesthetic procedures.
What does ANVISA have to do with facial harmonization?
Dermal fillers, toxins and other injectable products used in harmonization are subject to health regulations. In general, each product must have a health registration to be sold and used, and that registration comes with a risk classification. Fillers, for example, are usually treated as a Class IV medical device, the highest-risk class.
| Topic | What to check |
|---|---|
| Registration | Registration number on the packaging and in the official search |
| Lot and expiration | Recorded in the patient record, for traceability |
| Off-label use | Use outside the labeled indication, under the professional's responsibility |
| Technovigilance | Reporting problems with the product |
What should the professional do?
- Buy only registered products from a reliable source.
- Check the packaging, lot, expiration date and seal.
- Record the lot and expiration date in the patient record and, if possible, stick the product label there.
- Report serious adverse events through the official channels.
- Keep the clinic compliant with local health surveillance.
Sources
Product search, regulations and reporting channels are on the agency's official website, at gov.br/anvisa. Always check the current version of the rules, because they change.
Also called: National Health Surveillance Agency, federal health surveillance.
Frequently asked questions
How do I check whether an injectable product is registered with ANVISA?
Through the public product search on the agency's official website, using the product name or the registration number printed on the packaging. A product without registration should not be used.