Medical Equipment

We offer comprehensive and personalized legal support for companies that develop, manufacture, import, and market medical devices. Our services include the following:

• Regulatory Compliance: Guidance on ANVISA regulations and other applicable regulatory authorities (e.g., INMETRO, ANATEL).
• Contracts and Negotiations: Drafting and reviewing commercial contracts, supply and distribution agreements, and other legal instruments.
• Litigation and Disputes: Representation in judicial and administrative disputes.
• OPME (Orthotics, Prosthetics, and Special Materials): Specialized legal advice in the OPME market.
• Software as Medical Devices (SaMD): Guidance on ANVISA’s specific regulations and understandings. Drafting and reviewing licensing contracts. Legal support for HealthTechs and developers of medical software.
• Technovigilance: Assistance in reporting adverse events to ANVISA, conducting field actions and recalls. Interface with foreign headquarters and/or international partners in cross-border matters.
• Sanitary Infractions: Defense, appeals, and monitoring of sanitary infraction processes.
• Company Licensing: Assistance in obtaining the Authorization for Company Operation (AFE) from ANVISA, as well as local sanitary licensing.
• Import and Export Consultancy: Assistance in medical device import and export processes. Coordination with foreign law firms in internationalization processes of Brazilian companies.