Brazil: Anvisa Opens Public Consultation on Regulatory Sandbox Regulation

Anvisa has launched a public consultation on a proposed regulation establishing a regulatory sandbox framework within the Agency. The proposal aims to create a general procedure for the implementation of regulatory experimentation programs involving innovative products, services, processes, and business models subject to health surveillance regulation. The draft was submitted for public consultation following the approval of the Regulatory Impact Assessment (RIA) Report on the matter.

Key Highlights of the Proposal

• Establishment of a general regulatory framework for regulatory sandboxes at Anvisa
• Implementation of thematic sandbox cycles, to be launched through specific calls for applications published by the Agency
• Participation of startups, emerging companies, and established companies
• In certain circumstances, admission of developers not yet fully regularized with Anvisa
• Possibility of specific and temporary regulatory flexibilities, subject to monitoring and risk mitigation measures
• Preservation of ongoing regulatory experimentation projects, with no impact on initiatives currently underway

Why Is Anvisa Seeking to Regulate the Topic?

Although Anvisa has already conducted regulatory experimentation initiatives in specific sectors, including projects involving cosmetics and medical cannabis, the Agency does not yet have a general framework governing the structure and operation of such programs

According to the RIA, innovative technologies often face difficulties fitting within existing regulatory regimes. In some cases, applicable regulatory requirements may prevent the generation of the evidence needed for Anvisa itself to properly assess those technologies. The proposal seeks to create a controlled environment for experimentation while maintaining appropriate monitoring mechanisms and public health safeguards.

Legal Basis for the Proposal

One of the principal legal foundations of the proposed regulation is Brazil’s Startup Legal Framework (Law No. 14,182/2021), which expressly allows public authorities and entities to establish experimental regulatory environments.

Despite its connection to the startup ecosystem, the proposal is not limited to startups. The model may be used by a broad range of economic operators, including established companies developing innovative technologies or solutions that fall within Anvisa’s regulatory remit.

How Will the Model Operate?

The proposal establishes a sandbox model based on thematic cycles defined in advance by Anvisa. Participation will therefore not occur on a rolling basis. For each cycle, the Agency will publish a specific call for applications setting out the regulatory challenge to be addressed, eligibility criteria, and participation requirements.

Each sandbox program will be governed by its own protocol, defining:

• Regulatory requirements eligible for temporary flexibility
• Scope and boundaries of the experiment
• Monitoring mechanisms
• Risk mitigation measures
• Criteria for project completion or continuation

One of the proposal’s most noteworthy features is the possibility for developers of innovative technologies to participate even where certain regulatory registrations or authorizations have not yet been obtained, provided that applicable eligibility requirements and safeguards are met.

What Technologies May Be Covered?

The proposal does not create a sandbox dedicated to any specific sector or product category. Instead, it establishes a general framework that may be applied across different areas subject to health surveillance regulation whenever Anvisa identifies regulatory barriers that may be addressed through regulatory experimentation.

Throughout the RIA, Anvisa cites examples of technologies commonly associated with regulatory sandbox discussions, including: artificial intelligence in healthcare, digital health technologies, software-based medical devices, advanced therapies, personalised products and other emerging technologies that challenge traditional regulatory models

Public Consultation and Next Steps

The public consultation will remain open for contributions from 13 October to 11 December 2026. Stakeholders may submit comments on matters such as eligibility criteria, project governance, regulatory flexibility mechanisms, monitoring requirements, and the rules applicable following the conclusion of sandbox cycles.

The draft regulation also clarifies that the future framework is not expected to affect regulatory experimentation initiatives already underway at Anvisa, which will remain subject to the conditions established in their respective approval instruments.

This consultation represents an important step in strengthening regulatory mechanisms that support innovation in the healthcare sector and may expand the pathways available for assessing technologies that currently face challenges under existing regulatory frameworks.

The Life Sciences & Healthcare team at Souto Correa Advogados is available to discuss any questions regarding these developments.