Medical Devices

Brazil Medical Device Registration – Overview

Freyr provides comprehensive regulatory consulting and lifecycle management services for medical devices in Brazil, supporting manufacturers throughout the entire regulatory process, from the definition of the initial regulatory strategy to obtaining marketing authorization and ensuring post-approval compliance.

Our services are designed to help companies navigate the Brazilian regulatory framework before ANVISA, ensuring that medical devices comply with applicable technical, quality, and regulatory requirements prior to commercialization and throughout their entire market lifecycle. Freyr supports a broad range of medical devices, taking into account their classification, intended use, and risk profile, and adapts regulatory strategies accordingly.

By combining global regulatory standards with local regulatory expertise, Freyr Brazil assists its clients in managing regulatory submissions, maintaining regulatory compliance, and efficiently addressing regulatory changes, enabling timely market access and sustainable product lifecycle management in Brazil.

Regulatory Authority and Framework

In Brazil, medical devices are regulated by the National Health Surveillance Agency (ANVISA), the national health authority responsible for ensuring the safety, quality, and performance of health products before and after commercialization.

The regulatory framework for medical devices in Brazil is based on a risk management approach, under which regulatory requirements vary according to device classification, intended use, and the level of risk to patients and users. Compliance with applicable regulatory, technical, and quality requirements is mandatory for market access and continued commercialization.

Foreign manufacturers are required to appoint a local authorized representative or a legal entity established in Brazil to act as a regulatory liaison before ANVISA. This local representative is responsible for managing regulatory submissions, maintaining communication with the authority, and ensuring ongoing compliance throughout the product lifecycle.

Within this framework, regulatory oversight extends beyond the initial marketing authorization and includes post-market surveillance activities, change management, and compliance with applicable regulatory and quality obligations, reinforcing the importance of continuous regulatory management for medical devices marketed in Brazil.

Medical Device Classification in Brazil

The classification of medical devices in Brazil is established within the regulatory framework issued by ANVISA. Devices are classified based on their intended use and potential risk to the patient or user, following risk-based classification principles aligned with international standards.

In Brazil, medical devices are divided into four classes: Class I devices are considered low-risk products; Class II devices are considered medium-risk products; Class III devices are considered high-risk products and; Class IV devices are considered maximum-risk products.

ANVISA Legal Representation Services

Foreign manufacturers that do not have a legal presence in Brazil must designate a Registration Holder and/or local Legal Representative to commercialize medical devices in the country.

The legal representative is responsible for submitting the registration dossier, interacting with ANVISA throughout the entire evaluation process, and ensuring ongoing regulatory compliance once approval has been granted.

Medical Device Regularoty Pathways in Brazil

Considering that in Brazil medical devices are classified under a system of Classes I, II, III, and IV in line with international standards, the regulatory process provides for different pathways to market authorization, the applicability of which depends on the product’s classification and the existence of prior approvals in reference markets.

Class I and II devices are subject to notification, while Class III and IV devices require sanitary registration with ANVISA.

Accordingly, for Class III and IV devices, the registration process may follow different regulatory approaches, including:

Traditional pathway (standard procedure)

Applicable when no recognized regulatory precedent exists. This corresponds to the regular registration process, in which ANVISA performs a full technical assessment of the submitted documentation to verify the safety, efficacy, and performance of the device.

Equivalence pathway (optimized procedure)

Available for products previously approved by Equivalent Foreign Regulatory Authorities (AREE), as defined by ANVISA, including Australia, the United States, Canada, and Japan. In such cases, ANVISA may consider regulatory assessments conducted by these authorities, allowing for an optimized review of the registration process.

Post-Approval Medical Device Lifecycle Management

Post-approval change management

Administration and regulatory classification of modifications to the medical device sanitary registration, including the incorporation of new variants, accessories, changes to indications for use, or other updates that impact the authorized regulatory status, in accordance with the criteria and procedures established by ANVISA.

Renewal management

Support in the preparation and submission of applications related to the renewal of sanitary registration, in accordance with applicable timelines, conditions, and requirements established by ANVISA.

Liaison with the health authority (ANVISA)

Acting as a regulatory liaison between the manufacturer and ANVISA, facilitating communication during evaluation processes, regulatory follow-up, and post-market activities.

Importation process support

Regulatory support in managing requirements associated with the importation of medical devices registered in Brazil, in coordination with the authorities and stakeholders involved.