Overview
This blog post discusses recent ANVISA regulatory changes that directly impact the industries of medicines, medical devices, cosmetics, and sanitizing products, as well as dietary supplements. The goal is to provide a practical guide for regulatory affairs companies, such as GRP Brazil, to anticipate and adjust their processes, ensuring compliance and operational efficiency.
Introduction
In the dynamic world of regulatory affairs, staying updated is more than a necessity—it’s a critical success factor. ANVISA has been moving at a rapid pace, publishing new regulations and updates to modernize and strengthen sanitary surveillance in Brazil. For companies operating in this market, understanding and quickly adapting to these changes is essential to mitigate risks, optimize processes, and, most importantly, maintain product compliance. In this blog post, we detail the main regulatory updates affecting different sectors, offering a clear overview of how these new rules can impact your business.
Regulatory Affairs
1. What's New for Medicines and Medical Devices?
ANVISA is restructuring the regulatory landscape for health products. The main new development is the restriction on the simplified medicine registration procedure, directly affecting companies that operate with licensing or joint ventures. This change requires companies to review their registration strategies and business models to ensure they meet the new criteria.
Furthermore, the agency has encouraged innovation by extending the deadline for participation in a pilot project focused on the regulatory evaluation of innovative medical devices. This initiative shows ANVISA’s commitment to adapting its processes for the entry of new technologies, such as artificial intelligence applied to healthcare.
2. Updates for the Cosmetics and Sanitizing Products Sector
The cosmetics and sanitizing products sector has also undergone significant changes. One of the most notable is the obligation for companies to create channels for receiving consumer complaints. Additionally, the notification of serious adverse events to ANVISA has become a requirement, and companies need to update their labels and advertising materials.
Another crucial point is that the regularization of Cosmetics Degree 1 is now done exclusively through the digital platform Solicita/Datavisa, simplifying the process but demanding careful attention to detail and correct information entry.
3. Focus on Quality: Dietary Supplements in the Agency’s Spotlight
ANVISA has intensified its inspection of the quality of dietary supplements. One of the main reasons for product rejection is the lack of stability studies, which are fundamental to guaranteeing safety and efficacy over time. This warning from the agency reinforces the importance of a strict quality control and meticulous attention to the required technical documentation—a service where GRP Brazil can act as a strategic partner.
Conclusion
The recent movements by ANVISA make it clear that the agency seeks greater rigor and modernization in its processes. For companies that work with regulated products, these changes are not just challenges but also opportunities to improve product quality and operational efficiency.
Staying up-to-date with specific regulations and understanding their impact on your daily operations is essential for ensuring regulatory compliance and security. Count on GRP Brazil to be your strategic partner, helping you navigate these changes and transform regulatory complexity into a competitive advantage.
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.