Agência Nacional de Vigilância Sanitária-Anvisa

What Agência Nacional de Vigilância Sanitária-Anvisa does

Agência Nacional de Vigilância Sanitária (ANVISA) is Brazil's federal health surveillance agency, an autarquia operating under the Ministry of Health with statutory monopoly over the regulation of pharmaceuticals, medical devices, vaccines, cosmetics, food, sanitizing products, blood products, and health services in the national market. Its mandate covers the full lifecycle from product registration and market authorization through post-market surveillance, recall coordination under RDC 551/2021, and health-emergency response, with operational reach across all 26 Brazilian states and the Federal District via the federated Sistema Nacional de Vigilância Sanitária (SNVS). The agency exercises both routine oversight and high-impact enforcement, including the recent temporary discontinuation of Instituto Butantan's BUTANTAN-DV dengue vaccination campaign following ESAVI signal detection.

ANVISA's technology platform centers on proprietary regulatory data systems. SISTEC (Sistema de Tecnovigilância) publishes field-action and safety alerts; Notivisa is the institutional notification channel for adverse events and technical complaints related to health products; VigiMed extends spontaneous reporting to the general public; and the Open Data Portal publishes tecnovigilância panels and analytical datasets. The agency's outward communications are distributed through the gov.br/anvisa portal, social media (Instagram, Facebook, YouTube, X/Twitter), press releases, public consultations, newsletter, RSS, and the VLibras accessibility widget for Brazilian Sign Language users. Internationally, ANVISA participates in WHO, PAHO, and ICH harmonization networks for global pharmacovigilance and regulatory alignment.

ANVISA does not operate on a commercial revenue model. It is funded through Brazilian federal budget allocations and regulatory fees collected for product registrations, authorizations, and inspections, with no equity shareholders, venture backing, or stock listing. Its regulated constituents include multinational medical-device manufacturers (Philips, GE Healthcare, Siemens, Olympus, Elekta, Zimmer Biomet, Randox), domestic public laboratories (Fundação Ezequiel Dias), and Brazilian research institutions (Instituto Butantan), all subject to mandatory registration, inspection, and post-market surveillance obligations.

Name

Agência Nacional de Vigilância Sanitária-Anvisa

Legal name

Agência Nacional de Vigilância Sanitária

Website

https://antigo.anvisa.gov.br

Company type

Private

Operating status

Operating

Short description

ANVISA is Brazil's federal health surveillance agency, regulating pharmaceuticals, medical devices, vaccines, cosmetics, food, and sanitizing products through registration, post-market surveillance, and recall authority. It operates nationwide via the SNVS network and funds itself through federal budget allocations and regulatory fees.

Ownership category

akta.pro rank

Product category

Health Regulatory Services

NAICS

Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (92615), Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors (926150)

akta.pro primary industry

Drug Regulators (Human Pharmaceuticals) (HLAJADAA)

akta.pro secondary industries

Healthcare Compliance & Enforcement Authorities (HLAJACAB), Regulatory Compliance, Licensing & Enforcement (Public Health) (HLAJAMAE), Health Regulation, Licensing & Compliance (Public Health) (BPAIAJAN)

Keywords

• Health product regulation
• Pharmaceutical regulatory oversight
• Medical device registration
• Pharmacovigilance monitoring
• Sanitary surveillance services

Headquarters

HQ city

Brasília

HQ country

Brazil

HQ region

Latin America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure

Distribution channels3 records

Marketing channels9 records

Core offering

Brazil's National Health Surveillance Agency (Anvisa) regulates and monitors health products including pharmaceuticals, medical devices, vaccines, cosmetics, food, and sanitizing products. It issues market authorizations, conducts pharmacovigilance and tecnovigilância surveillance, coordinates product recalls and field actions, and operates proprietary safety reporting systems (Notivisa, VigiMed, SISTEC) through the national SNVS network.

Product overview

ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's national health surveillance agency operating through the gov.br portal. The agency provides regulatory services including a public alert system (SISTEC) for health product safety notifications, the Notivisa system for adverse event and technical complaint reporting, and an accessible web portal with VLibras support for Brazilian Sign Language users.

Differentiator

Problem solved

Functional benefit

Quantifiable outcome

• 4,393+ alerts processed through sanitary alert system covering medical devices, pharmaceuticals, and health products
• +2 more outcomes

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• Ministry of Health - Programa Nacional de Imunizações (PNI)coreStrategic or Co-development Partner · 1 June 2026ANVISA collaborates with the Ministry of Health's National Immunization Program for vaccine safety monitoring and regulatory oversight. Joint decision-making on temporary discontinuation of dengue vaccination campaign in June 2026 based on safety signal detection. The partnership coordinates between regulatory authority and public health implementation program.
• Instituto ButantancoreStrategic or Co-development Partner · 1 December 2025Instituto Butantan is the Brazilian research institution responsible for developing and registering the BUTANTAN-DV dengue vaccine. ANVISA registered the vaccine in December 2025 following clinical trial evaluation, and subsequently coordinated with Butantan on pharmacovigilance monitoring when safety signals were detected in June 2026, requiring temporary discontinuation of vaccination for investigation.
• Fundação Ezequiel Dias (FUNED)minorStrategic or Co-development PartnerFUNED is a Brazilian public health laboratory that conducted fiscal analysis (Laudo de Análise Fiscal) on health products. In Alert 5265, FUNED issued analysis report n. 2268.1P.1/2025/IOM/FUNED for Sutura MaxBraid product testing that identified unsatisfactory label analysis results, leading to product recall determination.
• Zimmer Biomet Brasil LtdaminorChannel Partner/ Reseller/ DistributorMedical device company that holds ANVISA registration for Sutura MaxBraid suture product. Subject to ANVISA regulatory oversight and field action coordination. Company CNPJ 02.913.684/0001-48 located in São Paulo required to execute product recall under RDC 551/2021.
• Olympus Optical do Brasil LtdaminorChannel Partner/ Reseller/ DistributorMedical device company holding ANVISA registration for Endoscopy equipment including UHI-4 Insufflator. Subject to ANVISA regulatory field action coordination for software updates addressing technical defects. CNPJ 04.937.243/0001-01.
• Elekta Medical Systems Comércio e Serviços Radioterapia LtdaminorChannel Partner/ Reseller/ DistributorRadiotherapy equipment company registered with ANVISA for Flexitron HDR brachytherapy system. Subject to field action coordination for safety communication regarding IU tube detachment issue. CNPJ 09.528.196/0001-66.
• Philips Medical Systems LtdaminorChannel Partner/ Reseller/ DistributorMedical imaging equipment company with multiple ANVISA registrations for Azurion, Allura Xper angiography systems, and Zenition surgical C-arm. Subject to regulatory oversight for HDD performance issue field actions affecting systems across Brazil's 26 states.
• GE Healthcare do BrasilminorChannel Partner/ Reseller/ DistributorMedical equipment company registered with ANVISA for X-ray systems including Optima XR200/220/240amx. Subject to field action coordination for column safety mechanism issues under FMI 10967 correction code. CNPJ 00.029.372/0001-40.
• Randox Brasil LTDAminorChannel Partner/ Reseller/ DistributorIn vitro diagnostic company holding ANVISA registration for urine analysis control products. Subject to recall coordination for ketone testing accuracy issue affecting batch 1380UC.
• Siemens Healthcare Diagnósticos LtdaminorChannel Partner/ Reseller/ DistributorDiagnostic reagent company registered with ANVISA for Flex Tacrolimus reagent for Dimension systems. Subject to field action coordination for positive bias issue affecting quality control and patient results with specific lot numbers.
• Pan-American Health Organization (PAHO)coreStrategic or Co-development PartnerANVISA participates in international regulatory networks through PAHO/WHO for vaccine safety information exchange, regulatory harmonization, and global health emergency coordination.
• World Health Organization (WHO)coreStrategic or Co-development PartnerInternational regulatory cooperation through WHO for global pharmacovigilance, vaccine safety monitoring, and health product regulatory harmonization initiatives.

Scale indicators7 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• U.S. Food and Drug Administration: The FDA is the US federal health product regulator overseeing pharmaceuticals, medical devices, vaccines, food, and cosmetics. It is the most direct functional analog to ANVISA in terms of mandate, scope, and authority structure across the product lifecycle.
• European Medicines Agency: The EMA regulates human and veterinary medicines across the EU with centralized scientific evaluation and member-state execution. It shares ANVISA's pharmacovigilance focus and lifecycle oversight approach for drugs and biologics.
• UK Medicines and Healthcare products Regulatory Agency: MHRA regulates medicines, medical devices, and blood components in the UK, executing comparable end-to-end oversight similar to ANVISA's mandate in Brazil across pharmaceuticals and medical devices.
• Health Canada: Health Canada regulates pharmaceuticals, biologics, medical devices, food, and cosmetics nationally. Its multi-product scope and federal department structure mirror ANVISA's authority and mandate.
• Japan Pharmaceuticals and Medical Devices Agency: PMDA reviews drugs and medical devices for safety and efficacy in Japan, providing comparable regulatory review and post-market surveillance functions to ANVISA for biologics and high-risk devices.
• Australia Therapeutic Goods Administration: TGA regulates therapeutic goods including medicines, medical devices, and vaccines in Australia, with a similar lifecycle oversight mandate and pharmacovigilance role to ANVISA.

Regional players

• Mexico Federal Commission for Protection against Sanitary Risks (Cofepris): Cofepris is Mexico's federal health regulator for health products, food, and cosmetics, making it a regional peer to ANVISA with comparable scope across Latin America's two largest health markets.

Broad incumbents

• China National Medical Products Administration: NMPA is China's national regulator for drugs and medical devices, providing large-scale regulatory authority comparable to ANVISA but operating within a much larger market and centralized framework.

Others

• Uppsala Monitoring Centre: UMC operates the WHO Programme for International Drug Monitoring and supports pharmacovigilance systems globally, including the data infrastructure used by ANVISA through VigiMed and WHO safety data exchange.
• Brazilian Ministry of Health: ANVISA's parent organization, responsible for broader health policy including the National Immunization Program with which ANVISA coordinates on vaccine safety and regulatory oversight decisions.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xtwitter.com/anvisa_oficial
• YouTubeyoutube.com/user/AudiovisualAnvisa
• Facebookfacebook.com/AnvisaOficial
• Instagraminstagram.com/anvisaoficial

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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M&A

Investments

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Frequently asked questions about Agência Nacional de Vigilância Sanitária-Anvisa