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ANVISA 2026-01-15

Importing regulated products into Brazil: step-by-step guide for foreign suppliers

Importing a regulated product into Brazil isn't just buying abroad and unloading at port. The flow goes through several systems — Siscomex, ANVISA, Federal Revenue — and any failure halts the cargo.

Pre-requisites for the importer

Before the first import, the importing company needs to be:

  • Registered in Radar Siscomex (Brazilian Federal Revenue) — modality matching volume
  • ANVISA AFE (Operating Authorization) covering the imported product class
  • Product registration/notification at ANVISA (with the importer's name on file)
  • Importer registered in ANVISA's system

What ANVISA is

The Brazilian Health Regulatory Agency (ANVISA) is the federal body regulating health products in Brazil — equivalent to the FDA. Cosmetics, supplements, medical devices, food, sanitizers and pharmaceuticals all need ANVISA approval.

The import flow

  1. International purchase (commercial invoice, packing list, BL/AWB)
  2. Product shipment with all technical documentation
  3. Arrival in Brazil — cargo stays in primary zone (port/airport)
  4. Import License (LI) in Siscomex — approved by ANVISA
  5. Sanitary Inspection Petition (LIVS/LMS) in ANVISA's SOLICITA
  6. Physical inspection when ANVISA determines — batch analysis, document review
  7. Sanitary clearance — registered in Siscomex
  8. Federal Revenue clearance — tax payment, final check
  9. Release to importer — cargo leaves the customs warehouse
Where it usually gets stuck

The most common errors: (1) AFE without the correct class, (2) product not registered in the right importer's name, (3) incomplete documentation in SOLICITA upload, (4) inconsistency between invoice and technical document. Each can cost days or weeks of held cargo — with storage fees running.

Technical documentation that travels with cargo

  • Commercial invoice (description, HS code, values)
  • Packing list with weights and dimensions
  • BL/AWB (bill of lading)
  • Certificate of Analysis (CoA) for the lot
  • Free Sale Certificate or equivalent
  • CBPF (Brazilian GMP certificate) of the manufacturer (for certain classes)
  • Technical manual / IFU for devices

Taxation

In addition to import duties, IPI, ICMS, PIS/Cofins-Import, the importer pays the TFVS (Brazilian sanitary inspection fee). Worth calculating the total landed cost before placing an order — in some cases, the Drawback regime or an Ex-tarifário position reduces impact significantly.

Holder Service for the importer

International companies that want the Brazilian market but aren't ready to open a subsidiary can use Holder Service — a Brazilian company holds the registration and acts as importing partner. It's faster (and cheaper) than opening a CNPJ.

For foreign suppliers

If you're shipping product to Brazil:

  1. Confirm your Brazilian partner is properly registered before shipping
  2. Match the product specification exactly to what's filed at ANVISA
  3. Send the lot's Certificate of Analysis with the shipment
  4. Include English-Portuguese bilingual labels when possible
  5. Verify your Free Sale Certificate is recent (within 2 years)

A coordinated start — technical packet aligned between manufacturer abroad and holder in Brazil — saves weeks of customs hold.

Need regulatory support in Brazil?

Wissen Consultoria serves companies across Brazil and international clients in ANVISA, MAPA, foreign trade and Holder Service. Reply within 1 business day.

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