Brazil

Brazil's primary health regulatory authority is ANVISA (Agência Nacional de Vigilância Sanitária), established under Law No. 9.782/1999 and operating under the Ministry of Health. ANVISA is responsible for the registration and post-market surveillance of pharmaceuticals, medical devices, in vitro diagnostics, and digital health solutions. All health products must obtain an ANVISA registration (Registro) or authorization before commercialization, with product risk classification determining the complexity and duration of the review process. Medical devices are classified under RDC 751/2022, pharmaceuticals under RDC 204/2017 and related resolutions, and in vitro diagnostics under RDC 36/2015, each establishing distinct dossier and technical requirements.

Applicants must appoint a locally established legal entity (Empresa Brasileira) as the regulatory holder, effectively requiring a local representative or subsidiary to hold the registration. ANVISA accepts dossiers structured according to the Common Technical Document (CTD) format for pharmaceuticals, and has progressively aligned with international standards through its membership in the International Council for Harmonisation (ICH) and the International Medical Device Regulators Forum (IMDRF). A significant reform introduced under RDC 204/2017 and expanded thereafter created a priority review pathway (Via Prioritária) for innovative products, orphan drugs, and products addressing unmet medical needs, reducing timelines substantially. ANVISA also recognizes prior approvals from reference regulatory agencies (FDA, EMA, Health Canada, TGA, among others) under its Recognized Foreign Registration pathway, which can accelerate approvals considerably for qualifying products.

Public health procurement in Brazil is predominantly structured through the federal Ministry of Health (Ministério da Saúde), which coordinates centralized purchasing for the Unified Health System (Sistema Único de Saúde, SUS). The SUS is a constitutionally mandated universal public health system, and procurement occurs through federal tender processes governed by Law No. 14.133/2021 (the New Public Procurement Law), which replaced the long-standing Law No. 8.666/1993. The central purchasing body, CONASS and CONASEMS (representing state and municipal health secretariats respectively), works alongside the Ministry of Health to manage both national tenders and decentralized state and municipal procurement. The national drug formulary (Rename) and the national medical device and health supplies list (Renases) determine which products are eligible for public procurement. Pricing for pharmaceuticals is regulated by the Drug Market Regulation Chamber (CMED), which sets maximum prices for both public and private channels.

The private sector represents a significant and growing channel, encompassing private hospitals, laboratory networks, pharmacy chains, and health insurance operators (Operadoras de Planos de Saúde) regulated by ANS (Agência Nacional de Saúde Suplementar). Multinational procurement channels such as PAHO/WHO revolving funds and UNICEF supply division play a limited but present role, primarily for vaccines and specific public health commodities. Brazil has a strong domestic manufacturing preference policy embedded in its industrial health complex strategy (Complexo Econômico-Industrial da Saúde, CEIS), which incentivizes technology transfer and local production through PDPs (Partnerships for Productive Development, Parcerias para o Desenvolvimento Produtivo). PDPs grant preferential public procurement to locally manufactured products in exchange for technology transfer to Brazilian public or private manufacturers, creating a structured market access pathway for international companies willing to localize production.