The Brazilian Health Regulatory Agency (Anvisa) has launched Public Consultation No. 1,427/2026 regarding a draft Collegiate Board Resolution (RDC) that establishes general rules for the operation of an experimental regulatory environment (Regulatory Sandbox). Contributions to this public consultation will be accepted until December 11, 2026.
The proposal aims to create a regulatory model that allows for the testing of innovative products and services subject to health oversight within a real-world environment, controlled and supervised by Anvisa. This mechanism may involve the temporary waiver or relaxation of certain regulatory requirements, with the goal of generating evidence to inform decision-making and potential improvements to health regulations.
Key aspects of the proposal include:
• Scope and Eligibility: The Sandbox may encompass various categories of products and services subject to health oversight, provided they offer verifiable benefits, present manageable risks, and have reached a sufficient level of maturity for experimentation. Participation will be contingent upon demonstrating that traditional regulatory mechanisms are inadequate to address the identified issue.
• Project Selection: Participation will be managed through public calls for proposals specific to each experimental cycle, with pre-defined criteria for eligibility, classification, and selection. The initiation of these cycles will be subject to technical assessment and deliberation by Anvisa’s Collegiate Board.
• Rule Relaxation: Selected projects may be granted temporary authorization, accompanied by an individualized protocol that outlines the specific rules being relaxed, the scope of the experimentation, and the applicable safeguards. Such relaxation will be limited to sub-legislative norms (regulations) under Anvisa’s jurisdiction and may not compromise established standards for quality, safety, or efficacy. • Finally, regarding monitoring and termination, participants must fulfill obligations related to transparency, incident reporting, and ongoing risk management. Anvisa may mandate adjustments, suspend authorizations, and establish measures for the discontinuation of projects. There is no guarantee that products will achieve regulatory compliance.
The definition of which projects may access the Sandbox warrants attention. Although the proposal establishes a general model applicable to various sectors regulated by Anvisa, the opening of new cycles will depend on the Agency’s institutional priorities and specific calls for applications. Consequently, no channel is created for the spontaneous submission of projects.
The public consultation offers an opportunity for interested sectors to evaluate and contribute to the refinement of eligibility criteria, the predictability of selection procedures, the scope of regulatory flexibilities, and the conditions governing participation, monitoring, and the termination of projects.
Leonardo Mattoso Sacilotto | leonardo.sacilotto@
Partner in the Environmental Law, Regulatory, and Biodiversity practice.
