After submitting a Class I medical device registration application with Brazil ANVISA, there are several regulations and requirements that manufacturers and Brazilian Registration Holders (BRH) must follow to ensure compliance. These include responsibilities during the review process, as well as obligations that continue after the device is approved and registered. Here’s an overview:

1. Track Application Progress and Respond to ANVISA Requests

• Monitor Application Status: Regularly check the application status through ANVISA’s online system or coordinate with your BRH for updates.
• Timely Responses to ANVISA Inquiries: If ANVISA requests additional documentation, clarification, or corrections, respond promptly to avoid delays.
• Documentation Amendments: Any changes or updates to submitted documents must be accurate and consistent with the original application.

2. Maintain Quality Management System (QMS) Compliance

• Ongoing QMS Compliance: For manufacturers with ISO 13485 certification, ensure the QMS remains in full compliance. Regular audits, corrective actions, and updates are necessary to maintain device quality and adherence to Brazilian standards.
• Alignment with GMP: ANVISA may require compliance with Good Manufacturing Practices (GMP) for medical devices under RDC 16/2013. Ensure all processes are compliant to avoid any issues during potential inspections.

3. Post-Market Surveillance (RDC 67/2009)

• Complaint Handling System: Develop and maintain a system to handle user complaints in Brazil, document them, and take corrective actions as needed.
• Adverse Event Reporting: Report any adverse events or incidents involving the device to ANVISA. This is essential for ensuring ongoing safety and regulatory compliance.
• Monitoring Device Performance: Continue to monitor the device’s performance in the Brazilian market, analyzing feedback to identify potential improvements or safety concerns.

4. Labeling and Language Compliance (RDC 185/2001)

• Label Updates: Ensure that the device labeling remains compliant with RDC 185/2001 and is available in Portuguese. Labels should include details like the device’s intended use, model, manufacturing and expiration dates, and BRH contact information.
• Changes to Instructions for Use (IFUs): If updates to the IFUs are needed, ensure they are translated into Portuguese and re-submitted to ANVISA if they affect the device's safety, performance, or user guidance.

5. Post-Approval Changes (RDC 102/2016)

• Notifying ANVISA of Changes: Any significant changes to the device—such as modifications in manufacturing processes, design, or intended use—must be notified to ANVISA. Some changes may require approval before they can be implemented.
• Distinguish Between Minor and Major Changes: Minor changes may only require notification, while major changes may require a new registration application. Consult with the BRH to ensure proper categorization and submission of changes.

6. Registration Renewal and Validity Management

• Five-Year Renewal: Class I medical device registrations are typically valid for 5 years. Plan to renew the registration well before it expires to avoid interruptions in the device’s market presence.
• Prepare Renewal Documentation: The renewal process may require updating technical documentation to reflect any changes made since the initial registration. Ensure that all supporting materials are current and compliant.

7. Product Recall and Field Safety Actions

• Recall Preparedness: Have a procedure in place for recalling the product from the market if safety or quality issues are identified.
• Field Safety Corrective Actions (FSCAs): In the event of serious safety issues, implement Field Safety Corrective Actions and inform ANVISA, the BRH, and affected users. This includes notification letters, corrective actions, and device modifications, if applicable.

8. Good Manufacturing Practices (GMP) Audits

• GMP Audit Readiness: While Class I devices may not always require strict GMP audits, ANVISA can conduct inspections if concerns arise. Be prepared to demonstrate compliance with RDC 16/2013 for Good Manufacturing Practices.
• Facility and Process Compliance: Ensure that all manufacturing facilities, quality controls, and documentation meet Brazilian GMP requirements to prevent disruptions.

9. Monitor Regulatory Updates from ANVISA

• Stay Informed on Regulatory Changes: ANVISA frequently updates its regulations and requirements for medical devices. Regularly review ANVISA’s website or consult with regulatory experts to ensure compliance with any new standards or guidelines.
• Adjust Practices as Needed: Be ready to adjust internal processes, documentation, or labeling based on new ANVISA regulations to avoid non-compliance.

10. Partner with the BRH for Ongoing Compliance

• Regular Communication: Maintain open communication with the Brazilian Registration Holder to coordinate compliance activities and manage any post-market requirements.
• BRH as Primary Liaison: Since the BRH is the primary point of contact with ANVISA, ensure they are proactive and responsive in handling regulatory matters, including post-market surveillance, adverse event reporting, and product renewals.

11. Language and Documentation Maintenance

• Portuguese Compliance: Ensure that any updates to documents, IFUs, or labels are accurately translated into Portuguese to meet regulatory standards.
• Document Retention: Keep all records, including original application documents, complaints, adverse event reports, and post-market surveillance data, organized and accessible for the entire device lifecycle.

Summary Checklist of Post-Application Requirements:

1. Track and Respond to ANVISA Inquiries – Monitor application status and respond to additional requests.
2. Maintain QMS Compliance – Continue adhering to ISO 13485 and Brazilian GMP standards.
3. Post-Market Surveillance – Set up systems for complaint handling and adverse event reporting.
4. Labeling Compliance – Keep labels updated and consistent with approved information in Portuguese.
5. Manage Post-Approval Changes – Notify ANVISA of any device changes, per RDC 102/2016.
6. Plan for Registration Renewal – Prepare for the 5-year renewal process in advance.
7. Recall and FSCA Procedures – Have recall and safety corrective action plans in place.
8. GMP Audit Preparedness – Be audit-ready in case of an ANVISA inspection.
9. Monitor ANVISA Regulations – Stay informed about regulatory updates.
10. BRH Coordination – Maintain close collaboration with the Brazilian Registration Holder.
11. Document and Language Compliance – Keep records accessible and ensure all documentation is in Portuguese.

Following these post-application requirements ensures compliance with ANVISA’s regulatory framework, helping maintain market access and avoid potential fines or recalls for Class I medical devices in Brazil.

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