How to Register Medical Devices with ANVISA in Brazil

ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian Health Regulatory Agency. It is the national authority responsible for regulating, approving, and monitoring products that may affect public health.

ANVISA plays a similar role to:

• FDA in the United States
• EMA in the European Union
• MHRA in the United Kingdom

The regulatory procedure varies according to the risk classification of the device (Classes I to IV).
In general, the process includes the following stages:

• Product identification and risk classification according to its intended use and level of invasiveness;
• Preparation of the technical dossier – this step is the main part of the process, containing detailed information on composition, safety, performance, labeling, and instructions for use;
• Submission of conformity and safety certificates, such as INMETRO or ANATEL approvals when applicable;
• Electronic submission and follow-up of the application through ANVISA’s system until the registration or notification is granted and published in the Official Gazette.

Each step requires technical expertise and familiarity with Brazil’s regulatory system, as well as continuous monitoring of regulatory updates.

In addition to ANVISA registration, certain medical devices must also obtain certifications from other regulatory bodies before being placed on the market:

• INMETRO Certification (Brazilian Institute of Metrology, Quality and Technology)
  Required for electrical and electronic medical devices that involve patient contact or are used for diagnosis or therapy — such as monitors, ventilators, infusion pumps, and other electromedical equipment.
  INMETRO ensures compliance with international safety standards (based on IEC 60601 series).
  
  
• ANATEL Certification (Brazilian National Telecommunications Agency)
  Required for medical devices that use wireless communication technologies such as Wi-Fi, Bluetooth, or RFID.
  Examples include patient monitoring systems, wearable medical devices, and telemetry or data transmission equipment.
  ANATEL certification ensures the equipment operates safely within Brazil’s radiofrequency spectrum.

Partnering with an experienced regulatory consultancy makes a significant difference throughout the process.
Specialized firms are familiar with ANVISA’s requirements, electronic submission systems, dossier formats, and the procedures for obtaining INMETRO and ANATEL certifications when required.

With professional support, manufacturers can:

• Avoid rework and application rejections;
• Gain speed in approvals and market entry;
• Save time and financial resources;
• Ensure ongoing compliance and product maintenance in the Brazilian market.

Registering a medical device with ANVISA is a strategic step toward operating with safety, legality, and credibility in Brazil.
Working with a specialized regulatory consultancy not only simplifies the process but also guarantees that all regulatory aspects — including INMETRO and ANATEL requirements — are properly managed, reducing risks, delays, and unnecessary costs.