Brazil Local Authorized Representative (AR)

For foreign manufacturers without a legal entity in Brazil, it is mandatory to appoint a locally based company as their Authorized Representative (AR) to represent their medical devices or IVDs in the country. The AR, also known as the Brazilian Registration Holder (BRH), ensures compliance with the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) regulations and facilitates market entry.

The BRH can be the manufacturer, importer, or another authorized representative, and their details must appear on the device's labelling. Without a BRH, a foreign manufacturer cannot register or market medical devices in Brazil.

ANVISA allows registration holders to authorize multiple companies to import products, providing flexibility for manufacturers. By appointing an independent BRH, manufacturers can maintain control over the distribution chain and minimize reliance on a single importer or distributor. Moreover, they can add or change distributors as needed without disrupting the device’s market authorization.

Liaison with ANVISA

The BRH serves as your official point of contact with ANVISA. This includes managing all regulatory communications with Brazilian authorities and responding to inquiries to ensure efficient, accurate communication.

Registration

The BRH is responsible for submitting and managing registration applications with ANVISA, thus ensuring the device is approved by ANVISA and can legally enter the Brazilian market. The BRH is responsible for the device’s commercialization after approval and holds legal accountability for the product safety and quality. The BRH also holds the registration certificate issued by ANVISA.

Documentation

The BRH must keep the technical dossier, labelling, Instructions for Use (IFU), and other documents available for ANVISA inspections. All regulatory submissions, labels and IFUs must be in Portuguese. These labelling requirements ensure safety, traceability, and regulatory compliance for medical devices marketed in Brazil.

Compliance

A local BRH ensures compliance with Brazilian regulations, smooths the approval process with ANVISA, and facilitates the supply of products in the Brazilian market. The BRH manages the Brazilian Good Manufacturing Practice (B-GMP) certification process to ensure compliance with Brazilian quality standards and handles post-market surveillance activities including vigilance, adverse event reporting, recalls, renewals, and modifications of device registrations.