Brazil is one of Latin America’s largest and most dynamic markets for pharmaceuticals, medical devices, and life sciences products, with strong growth potential and increasing demand for innovative healthcare solutions.
The Agência Nacional de Vigilância Sanitária (ANVISA), under the Ministry of Health, is the national regulatory authority responsible for the registration, inspection, and post-market oversight of drugs, medical devices, cosmetics, food supplements, and biologics. ANVISA enforces rigorous standards aligned with international guidelines (including ICH, IMDRF, and GMP), requiring detailed dossiers, local representation for foreign manufacturers, and compliance across the product lifecycle. MedWisdom LifeScience is dedicated to supporting global life sciences companies in navigating Brazil’s complex regulatory landscape. We provide end-to-end services, including regulatory strategy development, market intelligence, ANVISA submissions, local representation, and post-approval maintenance to ensure efficient market entry, sustained compliance, and long-term success in Brazil.
Get Brazil Compliance Support
Full support for ANVISA marketing authorization applications (including generics, similars, new drugs, and biologics) with complete dossier preparation and submission.
Guidance through ANVISA registration pathways (Class I–IV), CADIFA listing, and conformity assessment aligned with Brazilian Good Manufacturing Practices (B-GMP).
Preparation and submission of Clinical Trial Applications (Dossiê de Desenvolvimento Clínico – DDC) to ANVISA and CEP/CONEP ethics committees.
Support for clinical evaluation reports, performance evaluation studies, and post-market clinical follow-up for medical devices per ANVISA RDC requirements.
Compilation, submission, and maintenance of Drug Master Files (DMF) to ANVISA for active pharmaceutical ingredients and excipients.
Preparation for and support during ANVISA GMP/B-GMP inspections, internal QMS audits, and corrective action implementation.
Support for planning, CRO selection, protocol development, and regulatory submission of BE/BA studies required for generics and similars in Brazil.
Risk management file development per ISO 14971, ISO 13485 QMS implementation, and ANVISA-aligned risk-benefit analysis for devices.
Guidance on Brazilian GMP (RDC 658/2022) requirements, site readiness, documentation, and preparation for ANVISA GMP certification/inspection.
Compilation and submission of complete technical dossiers for medical devices (including STED format) to ANVISA for registration and renewal.
Local pharmacovigilance system setup, ANVISA adverse event reporting, PSUR/PBRER submissions, and risk management plan maintenance.
PMS/PMSR plans, vigilance reporting, field safety corrective actions (FSCA), trend analysis, and compliance with ANVISA post-market requirements.
Review and approval preparation of promotional materials, claims, and advertising to ensure compliance with ANVISA RDC 751/2022 and ethical standards.
Portuguese labelling review, IFU preparation, artwork compliance, readability testing, and ANVISA-specific requirements for drugs and devices.
Full support for drug labelling (bula, cartucho, rótulo), packaging updates, and compliance with ANVISA RDC 71/2009 and subsequent resolutions.
Assistance with ANVISA import/export authorizations, special permits, batch release certificates, and customs documentation for regulated products.
Partner with Medwisdom for expert, comprehensive, and compliant regulatory support in Brazil — from ANVISA registrations and GMP compliance to pharmacovigilance, labelling, and sustained market access.
Contact Our Brazil Regulatory Experts