New public call will select up to 10 projects for regulatory follow-up and reinforces the importance of a structured regulatory strategy from the earliest stages of development

Brazil’s National Health Surveillance Agency (Anvisa) has published Public Call Notice No. 5/2026, a new initiative aimed at selecting and providing regulatory follow-up for innovative medical device projects in Brazil.

The program is expected to select up to 10 projects with significant potential for Brazil’s healthcare system and represents an important opportunity for developers, manufacturers, startups, research institutions, and medical technology companies working with solutions that involve greater regulatory complexity.

The initiative follows the pilot project launched by Anvisa in 2023, when 107 proposals were submitted and 10 projects were selected for closer regulatory follow-up by the Agency.

More than a new selection process, the public call signals an important development in how medical device innovation can be addressed from a regulatory perspective in Brazil.

Why is Anvisa expanding this model?

The pace of technological development in healthcare has increased significantly in recent years.

Solutions involving artificial intelligence, medical software, new biomaterials, connected devices, advanced monitoring systems, diagnostic technologies, and high-complexity medical devices may present characteristics that do not always fit easily within traditional regulatory frameworks.

In this context, waiting until the registration application is submitted to discuss certain regulatory issues may create significant risks for a project.

These may include:

• the need to conduct additional studies;
• insufficient or inadequate clinical evidence;
• challenges in determining the appropriate regulatory classification;
• the need to revise technical requirements;
• delays in regulatory submissions;
• increased development costs;
• difficulties related to the market-entry strategy.

Anvisa’s proposed model is designed precisely to anticipate some of these discussions.

By establishing continuous communication between the Agency and the selected developers, regulatory challenges can be identified while the product is still under development.

Which projects are eligible?

According to Public Call Notice No. 5/2026, projects involving innovative medical devices classified as Risk Class III or IV may apply.

Among the criteria considered are technologies for which there are no comparable therapeutic or diagnostic alternatives already approved by Anvisa.

Projects that have the potential to offer significant advantages over currently available technologies may also be eligible.

The Agency has also indicated that certain projects will receive priority during the selection process.

These include projects that are:

• developed by Brazilian institutions;
• funded with public resources;
• related to women’s health.

Applications will remain open for 30 consecutive days from the publication date of the public call and must be submitted through the electronic form made available by Anvisa.

Up to 10 projects will receive regulatory follow-up

One of the key features of the initiative is the opportunity for continuous dialogue between the developers of the selected projects and Anvisa.

Under the conventional regulatory model, many product-related issues are formally assessed only during or after the regulatory submission process.

For innovative technologies, however, decisions made during the research and development stages can directly affect the future registration strategy.

Early interaction with the regulator may contribute to a better understanding of topics such as:

• device regulatory classification;
• applicable technical requirements;
• regulatory documentation;
• study design;
• required clinical evidence;
• safety and performance;
• risk management;
• regulatory development strategy.

This does not mean that approval requirements will be relaxed.

Medical devices will continue to be subject to the safety, quality, and efficacy requirements established under Brazilian health regulations.

The objective is to provide greater regulatory predictability for technologies that, precisely because of their innovative nature, may present challenges not yet fully addressed through traditional regulatory pathways.

Regulatory strategy should begin before registration

For companies operating in the medical device sector, the new public call reinforces an increasingly important principle: regulatory strategy should not begin only when the product is ready for registration.

In more complex projects, decisions made during development can directly influence the future approval of the device.

Factors such as intended use, target population, product claims, risk classification, technological architecture, clinical evidence, and technical documentation should be assessed in an integrated manner.

The more innovative the product, the greater the need for early regulatory planning.

A well-structured regulatory strategy can help companies identify risks before they become barriers to market entry.

What does the public call mean for international companies?

The program also deserves attention from foreign manufacturers interested in entering the Brazilian market.

Brazil is one of the largest healthcare markets in Latin America, but introducing medical devices into the country requires a detailed understanding of Anvisa requirements and the local regulatory framework.

For innovative technologies or higher-risk products, this preparation becomes even more important.

International manufacturers should assess, among other factors:

• the regulatory classification of the device in Brazil;
• technical documentation required by Anvisa;
• clinical evidence requirements;
• Good Manufacturing Practices (GMP) requirements;
• legal representation in Brazil;
• registration strategy;
• post-market obligations;
• potential differences between Brazilian requirements and those applicable in other markets.

The existence of regulatory follow-up programs focused on innovation demonstrates that Brazil’s regulatory environment is also adapting to the technological transformation taking place across the healthcare sector.

Innovation and regulation must advance together

Public Call Notice No. 5/2026 is aligned with Anvisa’s Innovation Policy, established under Ordinance No. 1,100/2023, and with the guidelines of Brazil’s Health Economic-Industrial Complex, established under Decree No. 11,464/2023.

The initiative aims to create conditions that allow new technologies to reach the healthcare system more efficiently without compromising the safety, efficacy, and quality standards required by health regulation.

For the medical device industry, the message is clear: technological innovation and regulatory strategy must evolve together.

How Register Medical Group can support your company

Register Medical Group provides regulatory support to companies seeking to develop, register, and commercialize medical devices in the Brazilian market.

With experience in regulatory processes and Anvisa requirements, RMG supports both Brazilian and international manufacturers in developing strategies for the different stages of bringing products to market in Brazil.

Our areas of expertise include:

• regulatory strategy for medical devices;
• product registration and regulatory compliance with Anvisa;
• registration hosting for international manufacturers;
• legal representation in Brazil;
• assessment and organization of technical documentation;
• support related to Good Manufacturing Practices requirements;
• audits and quality processes;
• distributor qualification;
• post-market requirements;
• support for establishing operations in Brazil.

For projects involving innovative technologies, early regulatory planning can be critical to reducing uncertainty and preparing the product for a more efficient regulatory review process.

Companies interested in Anvisa’s new program should carefully review the criteria established under Public Call Notice No. 5/2026 and assess the eligibility of their projects before the application deadline.

Register Medical Group is closely monitoring developments related to this initiative and remains available to provide additional clarification, assess potential regulatory implications, and support companies in determining the most appropriate strategy for their projects.

Access Anvisa Public Call Notice No. 5/2026.

Is your company developing an innovative medical device for the Brazilian market?

Register Medical Group can support the assessment of your regulatory strategy, technical requirements, and the pathways required to bring your product to the Brazilian market.

Register Medical Group — Regulatory expertise for companies expanding with confidence.