Bringing a medical device to market in both the United States and Brazil requires navigating two regulatory systems that share the same fundamental objective—ensuring device safety and performance—but differ significantly in classification, submission pathways, documentation, and market authorization requirements.
The U.S. Food and Drug Administration (FDA) and Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) both apply risk-based regulatory frameworks. However, a regulatory strategy developed for one market cannot simply be replicated in the other.
Understanding these differences early can help manufacturers avoid unnecessary delays, documentation gaps, and costly changes during the market-entry process.
In this article, we compare some of the key differences between the FDA and ANVISA regulatory frameworks for medical devices and highlight practical considerations for manufacturers planning access to the U.S. and Brazilian markets.
1. Device Classification: Three Classes vs. Four Classes
One of the first differences manufacturers encounter is the structure of the risk-classification systems.
In the United States, the FDA classifies medical devices into three classes—Class I, Class II, and Class III—based on the level of regulatory control necessary to provide reasonable assurance of safety and effectiveness. Class I generally represents the lowest level of regulatory control, while Class III devices are subject to the most stringent requirements.
Brazil uses a four-class system under ANVISA: Class I (low risk), Class II (medium risk), Class III (high risk), and Class IV (maximum risk). The applicable classification depends on factors such as the device’s intended purpose, duration of use, invasiveness, anatomical application, and other characteristics established by the applicable classification rules.
As a result, manufacturers should not assume that an FDA classification automatically corresponds to an equivalent ANVISA classification. Each device should be independently assessed under the regulatory framework of the target market.
2. Premarket Pathways and Market Authorization
The pathway to legally market a medical device also differs substantially between the United States and Brazil.
In the United States, the applicable FDA pathway depends on the device classification and regulatory status. Many Class II devices require a Premarket Notification [510(k)], in which the manufacturer demonstrates substantial equivalence to a legally marketed predicate device. Novel low- to moderate-risk devices without an appropriate predicate may follow the De Novo pathway, while most high-risk Class III devices require Premarket Approval (PMA), which involves a more rigorous scientific and regulatory review. Some lower-risk devices are exempt from premarket review.
In Brazil, medical devices regulated under RDC No. 751/2022 generally follow one of two premarket regularization regimes. Class I and Class II devices are subject to Notification, while Class III and Class IV devices require Registration with ANVISA. Notification does not involve prior technical review by ANVISA before the notification number is issued, although the manufacturer and Brazilian registration holder remain responsible for maintaining the required technical documentation and regulatory compliance.
This distinction is particularly important when planning a dual-market strategy. A device that requires an FDA 510(k), for example, may fall under ANVISA’s notification regime depending on its Brazilian risk classification. Conversely, the technical documentation prepared for one jurisdiction may still require adaptation before it can support market access in the other.
3. Technical Documentation Requirements
Both FDA and ANVISA expect manufacturers to maintain technical documentation demonstrating that a medical device is appropriately designed, manufactured, and supported by evidence of safety and performance. However, the structure, content, and submission requirements are not identical.
In the United States, the documentation submitted to FDA depends heavily on the applicable regulatory pathway. A 510(k), for example, focuses on demonstrating substantial equivalence to a legally marketed predicate device, while a De Novo request addresses a novel low- to moderate-risk device for which no suitable predicate exists. Premarket Approval (PMA), generally associated with high-risk devices, requires a more extensive demonstration of safety and effectiveness.
In Brazil, RDC No. 751/2022 establishes documentation requirements for medical device notification and registration. For Class I and Class II devices subject to Notification, the technical dossier must be prepared and maintained by the Brazilian notification holder even though it is generally not submitted for prior technical review by ANVISA. Class III and Class IV devices are subject to Registration and require a more extensive regulatory submission and review.
Manufacturers entering both markets should therefore avoid assuming that an FDA submission package can simply be reused unchanged in Brazil. Existing test reports, risk-management files, clinical evidence, labeling, and technical specifications may provide a strong foundation, but the documentation must be mapped against the specific requirements of the target jurisdiction.
4. Quality Management Systems and Manufacturing Requirements
Quality management systems are fundamental to medical device compliance in both the United States and Brazil, but manufacturers must understand the regulatory requirements applicable in each market.
In the United States, FDA’s Quality Management System Regulation (QMSR) became effective on February 2, 2026. The QMSR amended 21 CFR Part 820 and incorporates by reference ISO 13485:2016, bringing the U.S. framework into closer alignment with the internationally recognized medical device quality-management-system standard. Manufacturers must nevertheless account for FDA-specific regulatory requirements that apply in addition to the incorporated standard.
Brazil also establishes Good Manufacturing Practice requirements for medical devices. Manufacturers placing products on the Brazilian market must comply with applicable Brazilian requirements, including the Good Manufacturing Practices framework established by ANVISA. For higher-risk devices, ANVISA certification requirements can become an important component of the regulatory strategy.
For manufacturers operating internationally, alignment around ISO 13485 can reduce duplication, but it does not eliminate jurisdiction-specific obligations. A quality system that supports U.S. compliance should therefore be assessed against Brazilian requirements before market entry rather than assumed to be automatically sufficient.
5. The Role of the Brazilian Registration Holder
One of the most important practical differences for foreign manufacturers is the need for an appropriately authorized Brazilian entity to hold the device notification or registration.
For imported medical devices, the foreign manufacturer authorizes a Brazilian applicant to represent and commercialize its products in Brazil. The Brazilian entity becomes the notification or registration holder and assumes regulatory responsibilities associated with maintaining the product’s authorization in the Brazilian market.
This relationship deserves careful consideration. The registration holder is not merely an administrative intermediary. Its responsibilities may involve regulatory submissions, maintenance of required documentation, management of post-market regulatory obligations, communication with ANVISA, and implementation of applicable changes throughout the product lifecycle.
For U.S. manufacturers planning long-term expansion into Brazil, the selection and governance of this relationship should therefore be treated as part of the market-entry strategy. Regulatory responsibilities, access to technical documentation, change-control communication, post-market information, and commercial expectations should be clearly defined before the product is submitted to ANVISA.
6. Regulatory Timelines and Market-Entry Planning
Regulatory timelines in the United States and Brazil cannot be compared reliably through a single fixed number. The pathway, device classification, completeness of the documentation, need for additional information, certification requirements, and product-specific characteristics can all influence the time required to reach the market.
In the United States, a device may be exempt from premarket review or may require a 510(k), De Novo request, or PMA, depending on its classification and regulatory status. These pathways involve substantially different levels of review and supporting evidence.
Brazil follows a different structure. Class I and Class II devices are generally subject to Notification, which does not involve prior technical review by ANVISA, while Class III and Class IV devices require Registration. Additional requirements may also apply depending on the device, including conformity assessment and Good Manufacturing Practice certification.
For this reason, regulatory planning should begin before a manufacturer commits to a commercial launch date. Classification, applicable standards, required testing, technical documentation, labeling, local representation, and manufacturing compliance should be evaluated as interconnected workstreams rather than sequential tasks addressed only at the end of product development.
7. Key Considerations for U.S. Manufacturers Entering Brazil
For a U.S. medical device manufacturer, successful entry into Brazil requires more than translating an FDA-cleared product’s labeling into Portuguese.
A practical market-entry assessment should begin by confirming the Brazilian risk classification and applicable ANVISA pathway. The manufacturer should then evaluate whether its existing technical documentation and test evidence support Brazilian requirements, identify any country-specific conformity assessment or manufacturing certification obligations, and determine how labeling and instructions for use must be adapted for the Brazilian market.
The relationship with the Brazilian notification or registration holder should also be established early. Responsibilities for regulatory maintenance, product changes, post-market activities, technical documentation, and communication with the manufacturer should be clearly understood.
The most efficient strategy is usually to identify these differences before the submission process begins. Early regulatory mapping can reveal documentation gaps, testing needs, labeling changes, or local requirements while there is still time to address them without disrupting the commercial launch.
8. Final Considerations
FDA and ANVISA share the same fundamental objective: ensuring that medical devices placed on the market are safe, effective, and appropriately controlled throughout their lifecycle. Their regulatory systems, however, differ in classification, premarket pathways, documentation, local representation, and implementation requirements.
For manufacturers operating across both jurisdictions, the key is not to create two completely separate regulatory strategies, but to understand where existing evidence and quality-system elements can be leveraged and where country-specific adaptation is required.
A structured gap assessment between U.S. and Brazilian requirements can help manufacturers identify these differences early, reduce avoidable rework, and build a more predictable path to market.
Planning medical device market access between the United States and Brazil?
AVRA Medical Consulting supports MedTech organizations with regulatory strategy, technical documentation, quality-system compliance, and international market-access planning across U.S. and Brazilian regulatory frameworks.