Overview
Effective March 13, 2025, The Brazilian Health Surveillance Agency (Anvisa) will bring about a significant transformation in its document protocol processes. With the implementation of RDC 947, the submission of documents will be completely electronic, eliminating the need to receive paper files. This initiative seeks to modernize and optimize document analysis, as well as reducing costs related to digitization and physical storage.
Introduction
The digital age is transforming many sectors, and Health Surveillance couldn’t be left out. In a move towards modernization, The Brazilian Health Surveillance Agency (Anvisa) is implementing a significant change in its processes. From March 13, 2025, RDC 947 will come into force, making it compulsory to use the Electronic Protocol for all documents submitted to the agency. As a result, the use of paper will be completely eliminated, making procedures more agile, sustainable and efficient.
What changes with the new standard
With the implementation of the Electronic Protocol, all companies, health institutions and other applicants will have to submit documentation through Anvisa’s digital system. This includes product registration applications, renewals, registration changes and any other bureaucratic process regulated by the agency.
The main advantage of this change is the optimization of processes, significantly reducing analysis and decision times. In addition, significant savings are expected by reducing the use of paper and logistical costs, making the process more sustainable and efficient.
Benefits of Electronic Protocol
Agility and Efficiency – Digital submission speeds up the workflow, reducing deadlines and facilitating inspection.
Sustainability – Eliminating paper reduces environmental impact and printing and transportation costs.
Security and Traceability – The electronic system ensures greater control over processes, with a digital record of actions taken.
Accessibility – Companies and professionals can send documents from anywhere, without having to physically travel.
Making preparations
Companies and professionals who deal with Anvisa must adapt quickly to the new rules. To do so, we recommend
Register with Anvisa’s Electronic Protocol system;
Digitize all the necessary documentation according to the required standards;
Train teams to use the submission platform;
Keeping an eye on deadlines and new regulatory requirements.
Conclusion
The modernization of Anvisa with the definitive adoption of the Electronic Protocol represents a major step forward for health surveillance in Brazil. The measure promises greater efficiency, sustainability and security, benefiting both companies and regulatory bodies. Paying attention to the new rules and adapting to the requirements will be essential to ensure a more agile and effective process with Anvisa. GRP Brasil can help your company prepare. Contact our team.
GRP Brazil
If you are interested in registering your products in Brazil, GRP is ready to help. Our team of experts can simplify the process of registering products in Brazil and make it easier to schedule meetings with Anvisa more efficiently.
GRP can act as your local Agent & Register your product in U.S
Contact our team today to Inquire!
Email: info@globalregulatorypartners.com
Telephone : (+1) 781-672-4200
References
Learn more about Anvisa. For the link, click here
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and South Korea. GRP helps many life science companies register their products in different countries in compliance with local regulations.