Brazil

Brazil's primary health regulatory authority is ANVISA, established under Law No. 9.782/1999 and operating under the Ministry of Health. ANVISA oversees the registration and post-market surveillance of pharmaceuticals, medical devices, in vitro diagnostics, digital health software, and related health products. The general approval process requires submission of a registration dossier (petição de registro) through ANVISA's electronic platform, Solicita, followed by technical review, risk classification assessment, and issuance of a Registration Certificate (Registro de Produto). Products are risk-stratified: lower-risk items may qualify for simplified or notification-based pathways, while higher-risk products undergo full technical review. ANVISA also operates priority review pathways for products of high public health relevance, including those approved by reference stringent regulatory authorities (SRAs) such as the US FDA, EMA, or Health Canada.

All foreign manufacturers must appoint a locally registered Brazilian legal representative (Responsável Técnico) and an authorized importer or distributor (Empresa Detentora do Registro) to hold the product registration. Dossier standards are broadly aligned with ICH Common Technical Document (CTD) format for pharmaceuticals, and ISO-based technical documentation for medical devices and diagnostics. Brazil has progressively adopted RDC (Resolução da Diretoria Colegiada) resolutions to modernize its framework, including RDC 751/2022 for pharmaceuticals and RDC 830/2023 for medical devices, the latter aligning more closely with international standards such as IMDRF guidelines. ANVISA has also introduced an expedited pathway for digital health software (Software as a Medical Device, SaMD) under RDC 657/2022, reflecting growing market digitalization. Post-Brexit and post-pandemic reforms have accelerated convergence with global regulatory best practices, reducing duplication for products already cleared in recognized SRA jurisdictions.

Public procurement in Brazil is dominated by the federal Ministry of Health (Ministério da Saúde), which coordinates centralized purchasing through national tenders managed by the Departamento de Logística em Saúde (DLOG). The primary procurement mechanism is the Sistema de Registro de Preços (SRP), a price registration system enabling framework agreements that federal, state, and municipal health secretariats can access. Large-volume strategic products, including vaccines, antiretrovirals, and essential medicines, are procured centrally through the Ministry of Health and distributed via the national logistics network. Brazil's Unified Health System (Sistema Único de Saúde, SUS) operates on a federated model, meaning state (Secretarias Estaduais de Saúde) and municipal health secretariats also conduct independent procurement for locally managed health programs, creating a multi-tiered purchasing landscape. Public procurement is governed by the new Federal Procurement Law No. 14.133/2021, which modernized bidding rules, introduced greater use of electronic auctions (pregão eletrônico), and strengthened compliance and anti-corruption provisions.

The private sector represents a substantial and growing procurement channel, driven by a large supplementary health market regulated by the Agência Nacional de Saúde Suplementar (ANS), encompassing private health insurers, hospital networks, and diagnostic laboratory chains. Private procurement operates through direct commercial negotiations, group purchasing organizations, and distributor networks. Brazil participates selectively in donor-funded procurement channels: PAHO's Strategic Fund and PAHO/WHO Revolving Fund are used for select vaccines and public health commodities, and the Global Fund has historically supported HIV and tuberculosis programs. USAID and Gavi engagement is limited given Brazil's upper-middle-income status, though technical cooperation continues. Notably, Brazil maintains active local manufacturing preference policies under its Produção Nacional and Parceria para o Desenvolvimento Produtivo (PDP) programs, which incentivize technology transfer agreements with domestic manufacturers, granting preferred pricing and procurement advantages in SUS tenders to products with significant local content or national production partnerships.