New ANVISA Manual Guides Medical Device and IVD Manufacturers Through Brazil’s Regulatory Pathway
The Brazilian Health Regulatory Agency (ANVISA) has published a new edition of its Manual for the Regularisation of Medical Devices, providing detailed guidance to both national and international manufacturers seeking to place medical devices or in vitro diagnostic (IVD) products on the Brazilian market.
Why this matters
Brazil is Latin America’s largest medical device market, but navigating its regulatory system can be complex — especially for foreign manufacturers. ANVISA’s updated manual aims to simplify this process by consolidating the current legislation, practical procedures, and agency expectations into a single, user-friendly document.
What the new manual includes
The publication outlines the complete regulatory flow for devices and IVDs, covering:
Device classification rules for risk-based registration (Classes I to IV)
Required documentation for notification (notificação) and registration (registro) processes
Good Manufacturing Practice (GMP) certification and inspection procedures
Electronic submissions via the Solicita platform
Specific considerations for in vitro diagnostic (IVD) products
Renewal procedures, changes, and post-market obligations
Each step is explained with practical examples and updated references to the relevant ANVISA regulations (RDCs), making it easier for companies to comply.
Who should read it
The manual is a valuable tool for:
Brazilian manufacturers aiming for compliance and speedier approvals
International companies expanding into Brazil
Regulatory affairs professionals and consultants
IVD manufacturers navigating specific pathways
Although currently available only in Portuguese, it serves as an essential roadmap for any stakeholder preparing submissions to ANVISA.
The manual is currently available only in Portuguese, but it is a valuable reference for any company targeting the Brazilian market.
Source: ANVISA, October 2025
