Understand how the digitalization of ANVISA’s protocol impacts regulatory processes and how QR Group can help your company

As of March 13, 2025, the National Health Surveillance Agency (ANVISA) will implement a 100% digital protocol for receiving documents, as established by RDC 947/2024. With this change, the submission of paper documents will no longer be accepted, requiring companies in the health sector to use exclusively electronic petitioning systems, such as Solicita and SEI.

This measure aims to optimize procedural analysis, reduce operating costs, and ensure the security and authenticity of the information submitted. QR Group, a specialist in health regulation, is ready to help companies adapt to this new scenario and ensure compliance with ANVISA’s new guidelines.

Impacts of RDC 947/2024 on the Regulatory Process

The transition to the digital protocol will bring significant changes for manufacturers, distributors, and importers of healthcare products. Key impacts include:

• Elimination of the use of paper: All documents will need to be submitted electronically, eliminating the need for printing, transport, and physical storage.
• Greater agility in processes: ANVISA’s analysis and response time will be reduced, providing greater efficiency in the regulatory process.
• Guarantee of authenticity and security: Electronic documents will have a qualified or advanced digital signature, according to Law 14.063/2020, ensuring their integrity and authorship.
• Cost reduction: Companies in the sector will save on printing, scanning and physical storage of documents.

How QR Group Ensures Fast, Efficient Compliance

QR Group offers complete support for companies that need to adapt to the new regulation, ensuring that all documents are prepared correctly and sent within the standards required by ANVISA. Our services include:

• Assistance in electronic petitioning: Technical and strategic support for the use of Solicita and SEI.
• Validation of electronic signatures: Guidance on the implementation of qualified or advanced digital signature.
• Regulatory monitoring: Monitoring of regulatory updates and adaptation to legal requirements.

If your company needs support to adapt to ANVISA’s 100% digital protocol, contact QR Group and ensure compliance and agility in your regulatory process.

Source: ANVISA