Brazil

Brazil's primary health regulatory authority is the Agência Nacional de Vigilância Sanitária (ANVISA), established under Law No. 9.782/1999. ANVISA oversees the registration, post-market surveillance, and quality control of pharmaceuticals, medical devices, diagnostics, digital health software (Software as a Medical Device, or SaMD), and other health products. The general approval process begins with submission of a registration dossier through ANVISA's digital platform (SOLICITA/SEI), followed by technical review by the relevant product directorate. Risk classification determines the review pathway: lower-risk products may follow expedited or notification-based routes, while higher-risk or novel products undergo full technical analysis. Priority review tracks exist for products addressing unmet medical needs, neglected diseases, or public health emergencies.

All applicants must appoint a Brazilian legal representative (Responsável Técnico) and, for foreign manufacturers, a local regulatory holder (empresa detentora do registro) registered in Brazil. ANVISA accepts dossiers aligned with ICH Common Technical Document (CTD) structure for pharmaceuticals and has progressively harmonized device requirements with IMDRF frameworks. Brazil is a founding member of the Pan American Network for Drug Regulatory Harmonization (PANDRH) and participates in IMDRF, which has influenced recent reforms. Notable recent developments include RDC No. 204/2017 and its successors for medical devices, Resolution RDC No. 204 establishing a converged device registry (BNAFRO), the 2022-2023 reforms modernizing SaMD regulation under RDC No. 657/2022, and ongoing alignment of pharmaceutical registration pathways with ICH guidelines to reduce duplicative review burdens for products already approved in stringent regulatory authority (SRA) markets.

Brazil's public health procurement is primarily coordinated by the Ministério da Saúde (Ministry of Health), which operates through the Departamento de Assistência Farmacêutica e Insumos Estratégicos (DAF) for pharmaceuticals and the Departamento de Assistência Farmacêutica (DAFAR) and related units for devices and diagnostics. Centralized federal procurement is conducted via the Sistema Integrado de Administração de Serviços Gerais (SIASG) and formalized through atas de registro de preços (price registration records) and pregão eletrônico (electronic reverse auction) processes governed by the new Federal Procurement Law No. 14.133/2021. The Unified Health System (Sistema Único de Saúde, SUS) is the dominant public channel, serving approximately 75% of the population, and procurement decisions are heavily influenced by inclusion on the Relação Nacional de Medicamentos Essenciais (RENAME) and Relação Nacional de Ações e Serviços de Saúde (RENASES). Health Technology Assessment (HTA) conducted by the Comissão Nacional de Incorporação de Tecnologias no SUS (CONITEC) is a prerequisite for SUS reimbursement and public procurement inclusion, following a structured dossier and public consultation process. State and municipal health secretariats conduct their own complementary tenders, creating a federated procurement landscape that requires engagement at multiple governmental levels.

Brazil's private healthcare sector is substantial, representing approximately 25% of the population covered by supplementary health insurance (planos de saúde) regulated by the Agência Nacional de Saúde Suplementar (ANS). Private hospital networks, pharmacy chains, and diagnostic laboratory groups procure independently through commercial negotiations, group purchasing organizations (GPOs), and distributor agreements, often with faster adoption cycles than the public sector. Donor-funded procurement channels such as UNICEF Supply Division, the Global Fund, and USAID/PEPFAR play a limited but targeted role, primarily in the context of HIV/AIDS diagnostics and treatment, tuberculosis, and neglected tropical diseases, given Brazil's middle-income status. Brazil maintains strong local manufacturing preference policies, including the Complexo Econômico-Industrial da Saúde (CEIS) strategy and the Parcerias para o Desenvolvimento Produtivo (PDP) program, which incentivizes technology transfer agreements between foreign innovators and domestic manufacturers (public and private) as a condition of preferential public procurement access. Products manufactured domestically or through PDP arrangements may receive pricing advantages and preferred tender positioning under the Margem de Preferência framework.