Authorized representative

Brazil Medical Device Registration Holder

A foreign medical device manufacturer cannot obtain an ANVISA marketing authorization directly in its own name. It must work with a partner company legally established in Brazil that can act as the local applicant and take legal responsibility for the imported product in Brazil. This is often called a Brazilian Registration Holder (BRH) or Brazil Authorized Representative.

Choosing a local representative is therefore more than appointing a contact person. The Brazilian company’s name and responsibilities are connected to the product’s ANVISA regularization and to its supply in the country.

Brazil Authorized Representative: Key Information

The applicable route depends on product type, classification and intended purpose. IVDs have specific classification and regularization requirements under RDC 830/2023.

What Is a Brazilian Registration Holder?

ANVISA’s regulation defines a notification or registration holder as the legal entity responsible for the medical device in Brazilian territory that holds the authorization to commercialize it. ANVISA also states that foreign companies must have a partner company legally established in Brazil that is responsible for products imported and distributed in the country.

Brazilian Registration Holder is a common industry term for this service. In regulatory documents, the relevant terms include applicant and notification or registration holder. The appointed Brazilian company is not automatically just an administrative contact: it may hold the product’s Brazilian regularization and carry responsibilities associated with that role.

Is this the same as an EU Authorized Representative?

No. The roles are not interchangeable by default. The EU MDR uses the specific legal role of an EU Authorized Representative. For Brazil, the manufacturer works through a Brazilian established partner company, and the company submitting the application may become the notification or registration holder responsible for the product in Brazil. The contract and regulatory filing should clearly identify which company holds the authorization and what it is responsible for. 

Is a Local Representative Required in Brazil?

For a foreign manufacturer seeking to regularize medical devices in Brazil, ANVISA states that it must have a partner company legally established in Brazil. For imported devices, the application requires a statement issued by the legal manufacturer authorizing the requesting company to represent and commercialize the products in Brazil. The manufacturer’s statement must identify the legal manufacturer and the Brazilian requesting company, expressly authorize representation and commercialization in Brazil, and include the manufacturer’s acknowledgment of applicable Good Manufacturing Practices requirements. ANVISA specifies supporting statement requirements for both notification and registration applications.

What Does the Brazil Authorized Representative Do?

The Brazilian representative’s exact services should be set out in a written agreement with the manufacturer. Depending on whether it acts as the applicant or authorization holder, its work may include:

• Representing the manufacturer in the Brazilian regulatory process: Submit and follow  up on applicable ANVISA petitions through the required systems. 

• Coordinating product submissions: Support preparation of the required forms and  documentation for notification or registration. 

• Maintaining regulatory information: Coordinate submissions for applicable changes,  renewals, or other post-authorization actions. 

• Supporting ANVISA communications: Receive and coordinate responses to requests  related to the products and submitted petitions. 

• Coordinating local compliance activities: Support applicable labeling, import,  complaint-handling, vigilance and corrective-action processes, as allocated in the  agreement and required under Brazilian rules. 

• Supporting manufacturer authorization records: Maintain the manufacturer’s  authorization for the Brazilian company to represent and commercialize the products. • Managing changes to the relationship: Coordinate appropriate regulatory steps if the  representative, holder or product authorization needs to change.

ANVISA Notification and Registration Are Different

For many medical devices, the required regularization route depends on risk class:

Notification for risk Classes I and II

ANVISA uses notification for medical devices in risk Classes I and II. ANVISA describes this pathway as a regularization route that does not require prior technical analysis before the notification number is issued. The applicant still needs to meet the applicable documentation and regulatory requirements, and ANVISA may conduct subsequent audits.

ANVISA states that these notifications are valid for an indeterminate period and are exempt from renewal, although they may be cancelled by the holder or by ANVISA in specified circumstances.