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.

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.
• Holding or supporting product regularization: Act as the Brazilian applicant or notification/registration holder, as agreed and reflected in the filing.
• 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

These activities should be allocated carefully. The foreign manufacturer remains responsible for its own obligations, and appointing a local representative does not remove the need to meet applicable product, quality and post-market requirements.

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.

Registration for risk Classes III and IV

Medical devices in risk Classes III and IV generally follow the registration pathway. ANVISA’s service information states that a medical device registration is valid for 10 years from publication in Brazil’s Official Gazette.

 The regulatory route for IVDs is governed by RDC 830/2023, so IVD classification and submission requirements should be assessed under that regulation rather than assumed from the general device pathway.

Important 2026 Update: Foreign Manufacturer Code for Classes I and II

As of August 2026, ANVISA moved creation, amendment and inactivation requests for international medical device manufacturers in risk Classes I and II—including IVDs—to the Solicita system under petition subject code 80326. When granted, the Unique International Manufacturer Code is used in product regularization petitions.

 For risk Classes III and IV, ANVISA says the procedure remains unchanged and is carried out together with the application for Good Manufacturing Practices certification. Check ANVISA’s current instructions before filing, as this is a recent process update.

Brazil Medical Device Representation and Regularization Process

1. Confirm product type and risk classification

Identify whether the product is a medical device or IVD, then assess its classification and  applicable regulation. For general medical devices, RDC 751/2022 is a central regulation; IVDs  are covered by RDC 830/2023. 

2. Appoint a Brazilian partner

Select a company legally established in Brazil to act as the applicant and, where applicable, notification or registration holder. Define responsibilities, access to records, complaint escalation, regulatory communications and transition arrangements in the agreement.

3. Prepare the manufacturer authorization

The foreign legal manufacturer provides the statement authorizing the Brazilian applicant to represent and commercialize the product in Brazil. ANVISA specifies the information and declarations required in the statement.

4. Check the Brazilian company’s operating authorizations

If the local company will carry out regulated activities such as importing, distributing or storing medical devices, it may need an ANVISA Autorização de Funcionamento de Empresa (AFE) covering the relevant activity. ANVISA’s service page lists the activities for which AFE is required. The precise authorization depends on what the company will do.

5. Submit the applicable notification or registration

The Brazilian applicant submits the applicable product petition and supporting documents. The document checklist depends on the product and petition type. ANVISA’s registration service requires the applicant to have a CNPJ registered with ANVISA to access its Solicita system.

6. Address applicable GMP and product requirements

For relevant risk Classes III and IV, the foreign manufacturing site and product must meet applicable GMP and product requirements. ANVISA states that the GMP certification application protocol may be accepted to start a product marketing authorization review, but approval depends on publication of a valid certificate.

7. Maintain the authorization and local obligations

After regularization, the holder and manufacturer should maintain accurate product information and manage required changes and applicable post-market activities. If the representative or holder changes, the parties should confirm the regulatory steps required before relying on a new local arrangement.

How OMC Medical Can Support Your Brazil Market Entry

OMC Medical can help manufacturers assess their Brazil representation needs and coordinate the regulatory work involved in entering the market, including:

• Brazilian representative and holder role assessment
• Medical device and IVD pathway review
• Risk classification and document-readiness review
• Manufacturer authorization and submission coordination
• ANVISA notification or registration support
• Assistance with local regulatory communications and ongoing compliance planning