Regulatory updates

Date: February 18, 2026 The ANVISA has published Normative Instruction (IN) No. 426/2026, establishing the requirements for transmission and management of data within Brazil’s Unique Device Identification (UDI) database. The regulation strengthens traceability and transparency for medical devices marketed in Brazil and reinforces post-market control mechanisms. Entry into force: March 1, 2026Non-compliance will constitute a

Date: February 5, 2026 The ANVISA has published RDC No. 1.015/2026, revising and updating the regulatory framework for granting sanitary authorization for cannabis-based products in Brazil. This new resolution replaces the previous regulation and introduces several changes with significant commercial and compliance implications. The updated framework will enter into force on May 4, 2026. Key

Date: November 12, 2025 The ANVISA has updated its list of Equivalent Foreign Regulatory Authorities (AREEs) through the publication of Normative Instruction (IN) No. 403/2025. This list is used within ANVISA’s Reliance framework, allowing the Brazilian authority to leverage prior assessments conducted by recognized foreign regulators for specific regulatory procedures. What is the reliance process

Date: November 3, 2025 The ANVISA has approved a new regulation classifying sodium chloride-based products intended for nasal irrigation as medical devices. The decision was approved by ANVISA’s Collegiate Board (Dicol) on October 29, 2025 and formalized through a new Collegiate Board Resolution (RDC), granting the measure full regulatory and normative effect. What does the new

Date: October 29, 2025 The Federal Council of Medicine (CFM) has officially authorized the use of ozone therapy for specific medical indications through Resolution CFM No. 2,445/2025. This new resolution revokes Resolution CFM No. 2,181/2018, which had previously classified ozone therapy as an experimental procedure in Brazil. This update represents an important milestone for manufacturers

ANVISA presented the latest results of its Strengthening and Modernization Plan during a meeting of the Executive Group of the Health Economic-Industrial Complex (GECEIS), held in São Paulo on November 24, 2025. The initiative aims to reduce regulatory backlogs and improve review timelines across several product categories. Key progress highlights include Medical Devices : A