ANVISA is emerging as an active player in global regulatory governance. From assuming leadership positions at the International Medical Device Regulators Forum (IMDRF) to signing bilateral cooperation agreements with India and China, the Agency is clearly signaling its strategic direction. Here is an overview of recent developments in ANVISA’s international cooperation efforts and key highlights from its 2026-2027 Regulatory Agenda.
ANVISA's International Cooperation is Expanding
We have been following ANVISA's efforts to assume an increasingly strategic role, expanding its presence at international events and missions, establishing bilateral agreements, and reinforcing strategic alliances:
- Regional Integration in Latin America: The Rio de Janeiro Declaration marked an unprecedented commitment among Latin American countries to harmonize regulatory processes, strengthen trust among health authorities, and promote greater technical alignment.
- Leadership in Global Medical Device Forums: At the IMDRF, ANVISA assumed new strategic responsibilities, reinforcing its influence in defining international standards. The strengthening of the MDSAP and leadership in global working groups demonstrate Brazil's commitment to regulatory harmonization and the use of trust mechanisms between authorities.
- Bilateral Cooperation with Strategic Markets: Official missions to India and China expanded technical exchange, facilitated the recognition of good manufacturing practices, and opened doors for technological partnerships. These agreements strengthen essential production chains and accelerate access to innovative technologies.
- CELAC-Africa and the Construction of Common Regulatory Standards: Participation in the CELAC-Africa Forum reinforces the importance of cooperation between countries of the Community of Latin American and Caribbean States (CELAC) and African countries, promoting regulatory alignment and the exchange of experiences based on common challenges and shared solutions.
These initiatives demonstrate that ANVISA is aligned with international best practices and committed to regulatory convergence as a way to strengthen health security and expand access to health technologies.
Regulatory Convergence outlined in ANVISA's Regulatory Agenda
Within this context of global trends, ANVISA has been leading regional regulatory convergence initiatives, which can be seen through the themes of the 2026-2027 Regulatory Agenda. The Regulatory Agenda is an instrument for planning ANVISA's regulatory activity and therefore presents the set of priority themes to be regulated during its validity. Among the priority themes of ANVISA's Regulatory Agenda for 2026-2027, the following stand out:
- Review of the regulatory framework for technovigilance focusing on companies holding registration for medical devices: The proposal aims to modernize and improve the post-marketing surveillance process for medical devices, focusing on convergence with international best practices. It will affect the regulatory acts RDC 67/2009 and RDC 551/2021.
- Mandatory participation in MDSAP for the purpose of Certification of International Manufacturers of medical devices: Currently, international medical device manufacturers lacking MDSAP certification face long waits for ANVISA inspections for Good Manufacturing Practices (GMP) certification due to the high volume of applications and the Agency's limited capacity. Knowing that approximately 65% of GMP certifications are already granted by ANVISA through the MDSAP program, this proposal aims to establish the MDSAP program as the sole method for granting GMP certification to international companies. This will expedite GMP certification, allow for the reallocation of resources to ANVISA's GMP compliance monitoring activities, and strengthen international regulatory trust. It will affect regulatory act RDC 687/2022.
- Review of the regulation of software as a medical device (SaMD). The proposal aims to revise the current regulation (RDC 657/2022) concerning Software as Medical Devices (SaMD), which, despite being recent, already needs updating to keep pace with the evolution of a rapidly growing and expanding market, as well as to harmonize with international regulations and practices. It will affect regulatory acts RDC 657/2022 and RDC 751/2022.
Information is a Strategic Advantage in Brazil
For manufacturers, importers, and registrations holders, understanding these trends is essential to anticipate changes, adjust processes, and maintain competitiveness. It is crucial to have partners who can anticipate their practical impacts on your device’s compliance.
Our team monitors ANVISA's regulatory developments closely, including its activity in international forums, bilateral missions, and formal rule-making. If your company needs clarity on how these changes affect your specific products or registration status, we are ready to provide technical and strategic guidance as your in-country representative to keep you ahead of the curve. Learn more about ANVISA Brazil registration.
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