Health Registration: What It Means for Injectables
Quick facts
- Definition
- ANVISA authorization that allows the manufacture, import and sale of a product subject to health surveillance.
- Where to check
- On the official ANVISA website, using the registration or notification number shown on the packaging.
- What it guarantees
- That the product went through regulatory review; it does not guarantee results or the absence of risk.
- Relevance in orofacial harmonization (HOF)
- Using a product without valid registration exposes the patient and the professional to clinical, ethical and legal risks.
Health registration is the authorization granted by ANVISA (Brazil's health regulatory agency) for a product subject to health surveillance to be manufactured, imported or sold in Brazil. For aesthetic injectables, it is the document showing that the product went through review by the regulator, with analysis of safety, quality and the stated purpose.
What does registration mean, and what does it not mean?
A product with valid registration is one that can be sold and used according to the approved indication. That is different from guaranteeing results or absolute safety. Complications exist even with registered products, and registration does not replace clinical assessment, proper technique and consent.
| Registration indicates | Registration does not indicate |
|---|---|
| The product was reviewed by the regulator | That the result will be what the patient expects |
| A stated indication and risk class exist | That the product is indicated for any region of the face |
| The manufacturer or importer is identifiable | That the product is properly stored at the clinic |
| There is lot traceability | That the professional chose the right product |
In practice, hyaluronic acid fillers are treated as high-risk-class medical devices, covered in the entry on class IV medical device. Toxins are medicines, with their own rules. The classification defines the type of registration and who can buy and use the product.
How do you check it in daily practice?
Checking registration is a purchasing habit, not a rare event. With every new lot, it is worth checking the packaging, the number, the lot, the expiration date and the origin.
Suspicion of an irregular or counterfeit product should be handled as a technical complaint and reported to the surveillance channels, without using it on the patient. The page how to check an injectable's registration with ANVISA shows the step by step.
What are the risks of using an unregistered product?
For the patient, the risk is clinical: unknown composition, contamination, adverse reactions with no traceability and no safety data. For the professional, the risk is ethical and legal: liability before the professional council, health surveillance and the civil courts. A price far below market, sales through informal channels and no invoice are warning signs.
Even with a registered product, use outside the approved indication, known as off-label use, has consent and liability implications that must be assessed.
Also called: ANVISA registration, health regularization, notification (for some lower-risk products).
Frequently asked questions
How can I tell whether an injectable product is registered?
Check the registration number on the packaging and look it up on the official ANVISA website. Be wary of a product with no number, no lot or a nonstandard label. Checking is worthwhile with every purchase.