ANVISA Publishes RDC 982/2025: Understanding the Optimization of Risk Management and Compliance Monitoring
Keeping up with constant regulatory updates is essential for any company in the sector. The Passarini Group highlights the recent publication of ANVISA’s Collegiate Board Resolution (RDC) No. 982, from July 28, 2025, which arrives to enhance risk management and compliance monitoring processes.
This new resolution does not represent a radical change, but rather an evolution. It optimizes how ANVISA will use health risk management and compliance monitoring criteria for the initial granting or renewal of Good Practice Certificates.
What Does RDC 982/2025 Mean for Your Company?
In essence, the new RDC establishes a more modern and efficient framework for company evaluations. Instead of being a one-time process, risk management and monitoring become more integrated and continuous criteria in the agency’s decisions. This means that ANVISA will have a more complete and proactive view of each company’s compliance.
For you, this translates into the need to maintain a robust and up-to-date management system that demonstrates a constant commitment to quality and safety.
Key Points for Your Attention
- Does not revoke RDC 497/2021: It is crucial to note that RDC 982/2025 does not cancel the previous resolution. It acts as a complement, optimizing the application of risk management and monitoring already provided for in RDC 497/2021.
- Validity of certificates: The new RDC does not change the validity periods of existing certificates. Therefore, there is no need for immediate concern about the validity of your current documents.
- Focus on improvement: ANVISA’s goal is to make the certification process more assertive and aligned with the best practices of risk management.
The Passarini Group is attentive to all updates and ready to help your company navigate these changes. Understanding and adapting to these enhancements is crucial to ensuring compliance and success in your regulatory processes.
For a complete understanding of the resolution and its implications, the Passarini Group encourages reading the full document. Access Collegiate Board Resolution (RDC) No. 982/2025 directly to delve deeper into the risk management and monitoring criteria.
Need Help Adapting to ANVISA’s New Rules?
Understand how RDC 982/2025 can impact your company and ensure a smoother and more secure certification and renewal process.
Contact our team of experts and guarantee your business’s compliance. Send an email to contato@passarini.com.br
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