How to Check an Injectable's ANVISA Registration

Checking an injectable's registration is a five-minute task that protects the patient, the clinic, and your defense in the event of any complication. The search is public and free, but it has confusing details: medicines and medical devices sit in different areas, a single product can have several presentations, and "valid registration" does not mean "approved for any use".

This guide shows where to search, what to check for each type of product, and how to recognize signs of an irregular product. It refers to ANVISA, Brazil's health regulator. It does not name brands: the routine works for any trade name you want to verify.

What category is each injectable in?

Before searching, know which area of the system the product belongs to. The injectables used in HOF fall into different regulatory categories, each with its own rules and search screens.

Dermal fillers are regulated as risk class III or IV medical devices and may only be sold with ANVISA registration, as the agency itself reinforced in an alert dated March 12, 2026 (ANVISA news item).

Where is the registration number on the package?

The number appears on the package and labeling, generally preceded by "Reg. MS", "Registro ANVISA", or "Reg. ANVISA". According to ANVISA's guidance material for consumers:

A product with no number, a number in an odd format, or a label only in a foreign language is already a warning sign.

Step-by-step search

1. Have the package in hand. Note the trade name, registration number, holding company, lot, and expiration date.
2. Go to the query portal. The address is consultas.anvisa.gov.br. For medical devices, the health products area is at consultas.anvisa.gov.br/#/saude/. For toxin, use the medicines area.
3. Search by registration number. It is the most precise search. If you do not find it, try the trade name and then the company name or CNPJ (a company's tax ID in Brazil).
4. Open the result and check the status. The registration must be valid. Statuses such as expired, canceled, or lapsed indicate the product is not compliant.
5. Check the holding company and the manufacturer. They must match what appears on the package and the invoice. For imported products, also check the legal manufacturer and country of manufacture.
6. Check presentations and models. A single registration can cover several presentations. See whether the one you have is listed.
7. Open the documents. For health products, the search lets you access documents such as the instructions for use and labeling. For medicines, the approved package insert is in ANVISA's electronic library.
8. Read the indication and the intended areas. This is where you find out whether the area you plan to treat is covered by the registration.
9. Record it in the patient record. Product, registration number, lot, expiration date, and the date of the search. See patient records and documentation in HOF.

What should you check for each type of product?

For toxin, the package insert also carries reconstitution and storage information that changes from one product to another. The differences between products are in type A botulinum toxins: what changes between products, and the reason units are not interchangeable is in botulinum toxin in HOF: fundamentals.

For devices, the instructions for use are the document that defines areas, purpose, and precautions. ANVISA's 2026 alert recommends checking the areas and volumes listed in the instructions for use and giving the patient the product's traceability card, with a copy in the patient record.

Does a valid registration mean approved use?

No. Registration approves the product for what is described in the package insert or instructions for use. Applying it to another area, for another purpose, or in a different volume is off-label use. That decision carries regulatory, ethical, and legal responsibility for the professional.

Two situations come up often:

• Biostimulator in a body area or on the neck. The intended area varies between products of the same class. See biostimulator on the neck.
• Toxin in an area not listed in the package insert. Approved indications vary between products. See botulinum toxin in the masseter.

As for what each profession may do, the reference is your professional board, not the product's registration.

What are the signs of an irregular product?

• A price far below what regular distributors charge.
• Sale through social media, a messaging app, or an individual, without an invoice.
• A package without Portuguese labeling or with a sticker placed over the original.
• A registration number that is missing, illegible, or does not show up in the search.
• A holding company in the search different from the one on the package.
• A scratched-off lot or expiration date, or a tampered package.
• A promise of "the same imported product, cheaper".

What to do when something goes wrong?

• Suspected irregular product: do not use it, keep the package and the invoice, and report it through ANVISA's Ombudsman office on the Fala.BR system.
• Adverse event with a medicine (such as toxin): ANVISA points to the VigiMed system as the official reporting channel.
• Adverse event or technical complaint with a medical device (fillers, biostimulators, threads): use the channel for reporting product problems listed on ANVISA's website.
• Health alerts: ANVISA publishes alerts and measures about irregular products on the query portal. It is worth checking when a product you use appears in the news.

For the clinical management of complications, see safety and complications and hyaluronidase in the clinic.

How do you talk about this with the patient?

More and more patients ask, "Does this product have ANVISA approval?" Treat the question as a sign of trust, not distrust. ANVISA's campaign on safe procedures guides patients to check the product, the place, and the professional.

Citing the product and lot in the informed consent and the patient record reinforces this transparency.

Injectable compliance checklist

1. Product category identified: medicine, medical device, or cosmetic.
2. Registration number on the package, in the expected format.
3. Search done on the ANVISA portal, with valid status.
4. Holding company and manufacturer match the package and the invoice.
5. Package insert or instructions for use read, with indication and area checked.
6. Purchased from a regular distributor, with the invoice kept.
7. Product, registration, lot, and expiration date noted in the patient record.
8. Traceability card given to the patient, when available.