How to Register a Medical Device in Brazil

This video offers a practical, high-level walkthrough of the ANVISA medical device registration process in Brazil, including how to classify your device, prepare documentation, appoint a local representative, and navigate post-market requirements. Whether you’re expanding across Latin America or targeting Brazil specifically, this guide provides the clarity needed to move forward with confidence.

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As Latin America’s largest economy and one of the world’s top 10 healthcare markets, Brazil represents a critical opportunity for medical device manufacturers. With a population of 214 million, a universal healthcare system, and more than 50% of devices imported, demand is both deep and sustained. The medical device market is projected to reach $7.3 billion by 2028, while the smart-device segment alone is growing at 11.1% CAGR. But while the opportunity is clear, the regulatory pathway is complex and compliance with ANVISA requirements is non-negotiable.

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Before a device can be marketed in Brazil, manufacturers must navigate ANVISA’s four-tier risk classification system (Class I–IV), submit a detailed technical dossier, and in many cases, undergo Brazil GMP (B-GMP) inspections. Additional certifications may be required through INMETRO (for electrical safety) or ANATEL (for wireless technologies). Post-market surveillance and vigilance are also tightly regulated and must be built into your compliance strategy from the beginning.

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Topics covered in this video include:

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• Brazil's Medical Device Market Overview
  An overview of the opportunity, import trends, and long-term demand drivers.
• Regulatory Framework in Brazil
  Introduction to ANVISA and the primary regulatory pillars that govern device approvals.
• Medical Device Classification and Requirements
  How to determine your device’s risk class and what documentation is needed for each level.
• Marketing Approval and Post-Market Surveillance
  What’s required to obtain market clearance and how to maintain it through ANVISA-compliant vigilance programs.
• Brazil Local Representation
  The role of the Brazil Registration Holder (BRH) in submitting and maintaining your device license.
• How Pure Global Supports ANVISA Registration & Market Entry
  A look at how Pure Global simplifies ANVISA submissions and provides integrated support across Latin America.

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Need help registering with ANVISA?
Pure Global provides full-service support for medical device manufacturers entering the Brazilian market. From classification and technical file preparation to local representation, B-GMP readiness, and post-market compliance, we manage every step. Contact us to streamline your Brazil registration and accelerate LATAM market expansion.

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