Featured Products
Saline Syringe
10mL · box of 30
Nitrile Gloves
Blue · box of 100
Hypodermic Needle
Various sizes · box of 100
Macrodrip Set
Complete · each
Triple-Layer Mask
Surgical · box of 50
ANVISA Regulatory Services
Pmed Saúde specializes in ANVISA registrations, filings, validations, and other technical and regulatory needs for medical devices, cosmetics, sanitizers, food, pharmaceutical ingredients, and medicines. Host your registration in Brazil with confidence and security.
ANVISA Registration Holder
Brazilian Registration Holder for foreign manufacturers, with full regulatory compliance.
Operating Authorization (AFE)
Support obtaining AFE, Special Authorization (AE), and state and municipal health licenses.
GMP Certification (CBPF)
Technical support for Good Manufacturing Practices certification with ANVISA.
Product Registration
Strategy and execution of registrations for medical devices, cosmetics, sanitizers, food, and medicines.
Regulatory Consulting
Regulatory feasibility analysis, health classification, and responses to ANVISA technical requirements.
Import and Distribution Consulting
Structuring operations in Brazil, customs support, and document compliance for importers.
Structuring Operations in Brazil
Complete planning for international manufacturers to begin regulatory and commercial operations in Brazil.
Partner and Channel Management
Coordination of distributors and sales channels to maximize reach and compliance.
Regulatory Feasibility
Preliminary assessment of the pathway, timelines, and approval requirements for your product in Brazil.
