Overview
The Brazilian Health Regulatory Agency (ANVISA) recently participated in a major international event, where it reaffirmed its crucial role in monitoring drug safety. This blog details the main topics addressed by the Agency regarding Pharmacovigilance, the advancement in managing adverse events in Brazil, and the direct impact of these discussions on the operations and strategies of Regulatory Affairs companies in the sector.
Introduction
The term SaMD refers to software intended for medical purposes that functions independently of a hardware medical device. Think of apps that perform retinal diagnosis from a photo, or AI algorithms that analyze patient data to assist clinical decisions.
For this software to be used in Brazil, it must be formally registered. RDC 657/2022 is the main framework governing the registration and manufacture of these digital products, and its enforcement is intensifying. It is crucial for your company—whether a developer, distributor, or consultant—to understand these requirements.
Development: The Importance of RDC 657/2022 and the Training Opportunity
The regulatory landscape for SaMD in Brazil is rapidly evolving. ANVISA recognizes that, just like a physical piece of equipment (X-ray or scalpel), software that aids in diagnosis or treatment poses a potential sanitary risk if it fails. For this reason, RDC 657/2022 established strict quality and safety requirements that companies must adhere to.
Why Did ANVISA Expand the Inspection Course?
ANVISA recently expanded the target audience for the course “Introduction to Inspection in Companies Developing Software as a Medical Device (SaMD)”.
This measure serves two main purposes:
Knowledge Sharing: The training aims to share technical-regulatory knowledge about the inspection and sanitary oversight process in SaMD developing companies.
Market Training: By opening the course to a wider audience, including regulatory professionals, medical software developers, consultants, and other stakeholders, the Agency promotes education and prepares the market for full compliance with RDC 657/2022.
Key Takeaways for Readers
For those involved in the development, distribution, or consulting of digital health products, these are the critical points to note:
- RDC 657/2022 is the Foundation: Deeply understand the requirements of this RDC. It is your guide for the development, validation, and registration of SaMD.
- Digital Quality Management: Your software and its development process must follow a robust Quality Management System (QMS) that meets ANVISA’s requirements, including detailed documentation on the clinical and technical validation of the software.
- Increased Oversight: ANVISA’s investment in inspection courses indicates the Agency is preparing to actively inspect the sector. Compliance is not just bureaucratic; it is an operational necessity.
- Training Opportunity: Take advantage of the free course on “Introduction to Inspection in Companies Developing Software as a Medical Device (SaMD)”. This is a direct way to understand the inspector’s perspective and ensure your processes are audit-proof.
Conclusion
SaMD represents the future of healthcare, and Global Regulatory Partners Brazil closely monitors this regulatory progress. ANVISA is paving the way for digital innovation to be implemented safely. The best strategy is to be proactive: use the available training resources and ensure that the development and registration of your digital products are 100% compliant with RDC 657/2022. Patient safety begins in the software code.
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.
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.