Introduction:
Gaining ANVISA certification is a significant milestone for any medical device manufacturer aiming to access the Brazilian market. However, the journey doesn’t end with product registration. Maintaining ANVISA certification requires continuous compliance with post-market requirements set forth by Brazilian regulatory authorities. These obligations not only help safeguard patient safety but also ensure that your product remains legally marketed without interruption.
For manufacturers unfamiliar with the Brazilian regulatory framework, the post-market phase, often referred to as Vigilância Sanitária, can be complex. This blog provides a clear roadmap based on official ANVISA and Brazilian Ministry of Health regulations to help you stay compliant, proactive, and audit-ready.
1. Post-Market Surveillance in Brazil (Vigilância Sanitária )
Brazil mandates active post-market surveillance as a critical component of medical device compliance. As outlined in RDC 751/2022, manufacturers and local representatives must monitor product performance and ensure swift action in response to any adverse events.
Key obligations include:
- Ongoing collection and analysis of product performance data
- Periodic safety reviews
- Timely updates to ANVISA if new risks are identified
Failing to maintain effective post-market surveillance could lead to product recalls or even suspension of market authorization.
2. Incident Reporting and the TEC System
All adverse events or product-related technical complaints must be reported through the TEC (Tecnologia Envolvida em Comunicação) system, ANVISA’s official portal for incident communication.
According to RDC 67/2009, manufacturers are required to:
- Report serious incidents within 10 days
- Submit follow-up and final investigation reports
- Coordinate with the Brazilian representative (local MAH) to ensure timely submissions
Using the TEC system appropriately is not just a compliance requirement—it is a legal duty aimed at patient safety.
3. Product Traceability
Traceability is a foundational requirement under RDC 185/2001, especially for Class III and IV devices. Manufacturers must:
- Maintain distribution records
- Ensure that unique identifiers (e.g., IUM/UDI) are correctly used
- Support field safety corrective actions (FSCAs) if needed
These practices enable prompt recalls and risk management actions, demonstrating a commitment to public health and regulatory transparency.
4. Registration Renewals and Validity Monitoring
Although registration validity is typically 10 years (as per RDC 751/2022), failing to apply for renewal before expiration may require restarting the entire approval process.
Key tips:
- Begin renewal preparations 6–12 months in advance
- Review any accumulated change notifications
- Ensure updated labeling and IFU documents are included
Neglecting timely renewal can result in unnecessary market disruption.
5. ANVISA Inspections and Compliance Audits
Post-market inspections by ANVISA assess continued conformity with Brazilian Good Manufacturing Practices (BGMP), per RDC 665/2022.
What to expect:
- Documentation reviews of CAPA, complaints, and adverse event handling
- On-site or remote audits (especially during renewal or due to a reported issue)
- Sanitary surveillance agency (Visa) coordination at state or municipal levels
Best Practice: Maintain inspection readiness by regularly auditing your local importer’s files and your global QMS processes.
6. Labeling and IFU Updates
Any changes to labeling, Instructions for Use (IFU), or translations must comply with ANVISA requirements, as specified in IN 10/2021.
Updates may be required if:
- A new risk is identified
- A product indication is modified
- Regulatory text formatting evolves
Ensure that all updates are submitted via proper Alteração de Registro pathways and that local representatives align on language and content accuracy.
7. Change Notification (Alterações de Registro)
Any significant modification to a registered product must be notified or approved by ANVISA. Under RDC 340/2020, changes are categorized into:
- Type I (Minor) – e.g., administrative updates
- Type II (Moderate) – e.g., manufacturing site changes
- Type III (Major) – e.g., device design changes requiring prior approval
Each category has its own documentation and approval timeline. Understanding these distinctions helps avoid delays or regulatory non-conformance.
Best Practices to Maintain ANVISA Certification
- Assign a dedicated regulatory lead for Brazil post-market compliance
- Establish a compliance calendar with deadlines for renewal, inspections, and reporting
- Maintain open communication with your Brazilian distributor and legal representative
- Conduct internal audits aligned with ANVISA expectations
- Stay updated with changes in RDCs and INs via ANVISA’s portal
Conclusion:
Maintaining ANVISA certification goes beyond regulatory formality—it is a continuous demonstration of commitment to product safety, regulatory responsibility, and operational excellence in the Brazilian healthcare market. By proactively managing your post-market obligations, you ensure not only compliance but also sustained business continuity in one of Latin America’s most regulated markets.
For medical device manufacturers, understanding and meeting Brazil’s post-market requirements is not optional—it’s essential.
Sources:
- RDC 751/2022 – ANVISA RDC 751/2022
- RDC 67/2009 – ANVISA RDC 67/2009
- RDC 185/2001 – ANVISA RDC 185/2001
- RDC 665/2022 – ANVISA RDC 665/2022
- IN 10/2021 – ANVISA IN 10/2021
- RDC 340/2020 – ANVISA RDC 340/2020