Compliance
ANVISA Import Requirements
Health products, food, cosmetics, and pharmaceuticals — the registration and import requirements you must meet before shipping.
Updated May 2026
ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's FDA. If your product is a pharmaceutical, medical device, cosmetic, food product, or sanitizer, it needs ANVISA approval before it can enter Brazil. This guide covers the registration process, timelines, costs, and the critical details that foreign companies typically get wrong.
The fundamental rule: you need a Brazilian partner
Foreign companies cannot hold ANVISA registrations directly. Every registration requires a Brazilian legal entity (with CNPJ) as the registration holder. This means before you begin any ANVISA process, you need:
- A Brazilian distributor or importer willing to hold the registration, OR
- A Brazilian subsidiary (your own entity in Brazil), OR
- A regulatory agent (empresa importadora por conta e ordem) — a company that specializes in holding registrations for foreign firms
The holder is legally responsible for the product in Brazil — including adverse event reporting, recalls, and compliance monitoring.
Product categories and timelines
| Category | Type | Typical timeline | Estimated cost |
|---|---|---|---|
| Cosmetics (Grade 1) | Notification | 30-60 days | R$ 2,000-5,000 |
| Cosmetics (Grade 2) | Registration | 90-180 days | R$ 5,000-15,000 |
| Medical devices (Class I-II) | Notification (cadastro) | 60-120 days | R$ 5,000-20,000 |
| Medical devices (Class III-IV) | Registration (registro) | 6-18 months | R$ 30,000-100,000+ |
| Pharmaceuticals (generic) | Registration | 12-24 months | R$ 100,000-500,000+ |
| Pharmaceuticals (new molecule) | Registration | 18-36 months | R$ 500,000+ |
| Food (processed) | Registration | 60-120 days | R$ 3,000-10,000 |
| Food supplements | Notification | 30-60 days | R$ 3,000-8,000 |
Costs include ANVISA fees (GRU) + typical regulatory consultant fees. Complex cases may exceed these ranges.
Medical devices: the four risk classes
ANVISA classifies medical devices by risk level, which determines the registration pathway:
Low risk — Notification (cadastro)
Bandages, tongue depressors, manual wheelchairs, stethoscopes. Self-classification by the holder.
Medium-low risk — Notification (cadastro)
Powered wheelchairs, surgical gloves, blood pressure monitors, dental materials.
Medium-high risk — Registration (registro)
Ventilators, orthopedic implants, dialysis machines, coronary stents, X-ray machines.
High risk — Registration (registro) + stricter review
Heart valves, pacemakers, defibrillators, breast implants, IVD reagents for HIV/hepatitis.
GMP (Good Manufacturing Practices) inspection
For pharmaceuticals and Class III/IV medical devices, ANVISA may require a GMP inspection of your manufacturing facility — wherever it is in the world. Key details:
- ANVISA inspectors travel to your factory. You pay their travel costs (GRU taxa).
- Inspection follows ANVISA's RDC norms, which are largely aligned with WHO and PIC/S standards.
- If your facility has EU GMP or FDA cGMP certification, this helps but doesn't exempt you from ANVISA inspection.
- GMP certificate validity: 2 years. Must be renewed before expiration or you lose the ability to import.
- Scheduling backlog: 3-12 months between request and actual inspection visit.
The EU-Mercosur agreement includes provisions for mutual recognition of GMP, which may shorten this process for EU manufacturers in the coming years.
Labeling requirements
All ANVISA-regulated products must have Portuguese-language labeling before they can be sold in Brazil. For imported products:
- Primary packaging must include: product name in Portuguese, composition, net contents, manufacturing date, expiration date, batch number, manufacturer name and country, Brazilian holder's name and CNPJ
- Secondary packaging adds: usage instructions in Portuguese, warnings, storage conditions, ANVISA registration number
- Labels can be adhesive stickers applied over the original foreign-language labels — but must cover all required information
- For cosmetics: ANVISA allows bilingual labels (original language + Portuguese) as long as Portuguese is equally legible
Common questions
?What is a CNPJ?
CNPJ (Cadastro Nacional da Pessoa Jurídica) is Brazil's national business registry number — equivalent to an EIN (US), Company Number (UK), or Handelsregisternummer (Germany). Every company that imports into Brazil must have a CNPJ.
CNPJ registration guide?What is an NCM code?
NCM (Nomenclatura Comum do Mercosul) is Brazil's 8-digit tariff classification code. The first 6 digits match the international HS (Harmonized System) code — the remaining 2 are Mercosur-specific. Every import tax rate in Brazil is determined by the NCM code.
HS → NCM lookup tool?What is RADAR?
RADAR (Registro e Rastreamento da Atuação dos Intervenientes Aduaneiros) is Receita Federal's mandatory import/export authorization. Your Brazilian buyer needs active RADAR before any goods can clear customs. It comes in three modalities with different value limits.
RADAR & customs clearance guideCommon mistakes and how to avoid them
- Starting the registration process after the first order
ANVISA registration should start 6-12 months before you plan to ship. Begin the process as part of market entry strategy, not as a reaction to a purchase order.
- Wrong risk classification for medical devices
Misclassifying a Class III device as Class II means your notification will be rejected and you restart the process — losing months. Invest in a Brazilian regulatory consultant for proper classification.
- Not maintaining the registration
ANVISA registrations expire (5 years for drugs, 10 years for medical devices). Renewal must be filed before expiration. A lapsed registration means immediate import block.
- GMP certificate lapse
If your GMP certificate expires, all products from your facility are blocked — even if the product registration is valid. Track both expiration dates independently.