ANVISA RDC 982/2025: Brazil's New Risk-Based Certification System

On July 28, 2025, Brazil's National Health Surveillance Agency (ANVISA) published Resolution RDC No. 982, a transformative regulation introducing health risk management and compliance monitoring as key factors in the issuance and renewal of Good Manufacturing Practices (CBPF) and Good Distribution and/or Storage Practices (CBPDA) certificates.

Officially published in the Diario Oficial da União on July 29, 2025, RDC 982/2025 applies to establishments handling Active Pharmaceutical Ingredients (APIs), medicines, biologicals, medical devices, and cannabis-based products for medicinal use.

Key Changes Introduced by RDC 982/2025

1. Risk-Based Certification Criteria Under RDC 982, ANVISA now evaluates certification applications based on:

• Product risk class and classification

• Establishment complexity and criticality

• Compliance history with Good Manufacturing and Distribution Practices

• Valid inspection reports or certificates from internationally recognized regulatory bodies

2. Recognition of International Regulatory Authorities Accepted reports or certificates can now come from:

• Equivalent Foreign Regulatory Authorities (AREEs)

• Members of the Pharmaceutical Inspection Co-operation Scheme (PIC/s)

• Health authorities from International Medical Device Regulators Forum (IMDRF) countries

• Audits under the Medical Device Single Audit Program (MDSAP)

This marks a move toward global harmonization and regulatory reliance, streamlining Brazil's approval processes.

Impact of RDC 982/2025 on Market Access and Compliance

For Manufacturers and Distributors Certification timelines may shorten thanks to recognized third-party audits and reduced inspection frequency for low-risk or high-compliance sites.

For Importers and Exporters Harmonized standards ease cross-border operations and facilitate quicker market entry into Brazil.

For Compliance and Quality Teams A robust quality management system and proactive documentation are essential to meet the new evaluation framework.

How to Comply with ANVISA’s RDC 982/2025

1. Review Product Classifications: Understand your portfolio's risk levels.

2. Analyze Compliance Records: Gather internal audit outcomes and previous inspection data.

3. Obtain Recognized Certificates: Ensure availability of inspection reports from AREE, PIC/s, IMDRF, or MDSAP.

4. Enhance Internal Controls: Align quality and risk management systems with ANVISA’s expectations.

Conclusion

RDC 982/2025 modernizes Brazil’s regulatory framework by introducing a health risk-based model for GMP and GDP certifications. Its adoption of international audit equivalence will reduce redundancy and accelerate access to Brazil’s health products market. Companies that align quickly with these new standards will benefit from regulatory predictability and efficiency.

For official details, read the full publication: ANVISA RDC 982/2025 - IN.gov.br

Learn more about ANVISA Brazil Medical Device Registration.

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