For Class I medical devices registered with Brazil ANVISA, periodic updates ensure that the product continues to meet regulatory standards throughout its lifecycle. Updates can stem from product modifications, regulatory changes, or regular renewals. Below are the key standards and processes to follow for periodic updates:

1. Registration Validity and Renewal (RDC 250/2019)

• Five-Year Validity: Class I medical device registrations are valid for 5 years. A renewal application must be submitted before the registration expires to maintain the device’s market presence.
• Renewal Requirements: For renewal, provide updated technical documents, including proof that the device’s quality, safety, and effectiveness continue to meet ANVISA’s requirements.
• Renewal Documentation: Include any updates made to the device during its registration period, such as manufacturing changes, new testing, or adverse event data.

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

• Notification of Changes: Any significant modifications to the device, such as changes in design, intended use, or manufacturing process, must be reported to ANVISA.
• Classify Changes Appropriately:
  • Minor Changes: These might include minor adjustments that do not impact device safety or efficacy (e.g., packaging updates). ANVISA may only require a notification.
  • Major Changes: If the change affects safety, performance, or intended use, ANVISA will likely require a formal submission and possibly a new registration.
• Documentation for Changes: For major changes, update relevant technical documentation (e.g., risk analysis, validation tests) to reflect the modifications and their impact.

3. Risk Management and Safety Updates (ISO 14971)

• Risk Management Compliance: Regularly review the device’s risk management file to ensure it aligns with the latest standards and reflects any newly identified risks.
• ISO 14971 Updates: Update the risk management file if any significant risks are identified post-market or if new risk controls are implemented. Maintain thorough records to demonstrate ANVISA compliance.

4. Post-Market Surveillance and Adverse Event Reporting (RDC 67/2009)

• Ongoing Monitoring: Implement a system to continuously monitor the device’s safety and effectiveness in the Brazilian market.
• Adverse Event Reporting: If adverse events or issues occur, report them to ANVISA. This data helps determine if safety or performance adjustments are necessary.
• Documentation of Surveillance Activities: Keep a record of all surveillance and corrective actions for ANVISA review during renewals or inspections.

5. Labeling and IFU Updates (RDC 185/2001)

• Regular Labeling Review: Ensure that all labeling (product labels, packaging, and Instructions for Use) is up-to-date, accurate, and compliant with ANVISA’s requirements.
• Portuguese Requirement: Labeling must be in Portuguese and should contain updated information on usage, risks, and safety precautions.
• Notification of Labeling Changes: Minor changes to labeling that do not affect safety or efficacy might only need a notification. Major changes, especially those impacting usage instructions, should be reported to ANVISA.

6. Quality Management System (QMS) Compliance and Audits

• Ongoing QMS Review: Regularly update and audit the QMS to ensure it meets ISO 13485 standards and any specific requirements by ANVISA.
• GMP Compliance (RDC 16/2013): ANVISA requires adherence to Good Manufacturing Practices (GMP). Any changes to production processes, equipment, or facilities should be documented and reflected in QMS updates.
• Prepare for Audits: ANVISA may perform GMP audits if they suspect non-compliance. Maintain records to demonstrate ongoing adherence to QMS and GMP standards.

7. Local Representation with the Brazilian Registration Holder (BRH)

• Maintain Active BRH: The BRH must be consistently engaged and responsible for managing ANVISA-related communications and ensuring ongoing compliance.
• BRH Responsibilities: Ensure the BRH is proactive in handling updates, monitoring market feedback, reporting adverse events, and coordinating periodic renewals.
• Legal Agreement: Keep the legal agreement with the BRH updated to reflect any changes in roles or responsibilities.

8. Documentation and Language Requirements

• Maintain Portuguese Translations: All technical documentation, updates, and notifications to ANVISA must be available in Portuguese.
• Document Retention: Keep all records accessible throughout the device’s registration period, as well as for the lifecycle of the device, to facilitate reviews or inspections.

9. Process for Updating Documentation

• Compile Updated Technical Documents: For each periodic update or change, prepare relevant documentation, such as updated risk management files, biocompatibility studies, or performance data.
• Revalidate Device Performance: If the device undergoes significant changes, conduct tests (e.g., biocompatibility, mechanical stability) to ensure the device meets regulatory standards.
• Submit Updated Documents to ANVISA: When required, submit the revised documentation to ANVISA, ensuring all documents are translated into Portuguese. The BRH typically handles submissions for foreign manufacturers.

10. Stay Informed on ANVISA Regulatory Changes

• Monitor Regulatory Updates: ANVISA regularly updates its guidelines and requirements. Stay informed through the ANVISA website or work with a regulatory consultant familiar with Brazilian regulations.
• Adjust Practices Accordingly: Implement new or revised processes as needed to stay compliant with current ANVISA requirements.

Summary Checklist for Periodic Updates of Class I Medical Device Registration with ANVISA:

1. Track Registration Validity – Plan for the 5-year renewal and prepare updated technical documentation.
2. Update for Post-Approval Changes – Notify ANVISA of significant changes, following RDC 102/2016.
3. Risk Management Compliance – Update risk assessments as needed per ISO 14971.
4. Post-Market Surveillance – Continue monitoring and reporting adverse events to ANVISA.
5. Review Labeling and IFUs – Ensure accurate, Portuguese-language labeling in line with RDC 185/2001.
6. QMS and GMP Compliance – Keep QMS aligned with ISO 13485 and RDC 16/2013.
7. Coordinate with BRH – Keep BRH engaged in ongoing compliance and updates.
8. Portuguese Documentation – Submit updates in Portuguese as required.
9. Submit Updated Technical Files – Submit necessary documentation for renewals or significant changes.
10. Stay Updated on Regulatory Changes – Monitor ANVISA updates and adjust compliance practices as needed.

Following these standards and processes ensures that Class I devices remain compliant with ANVISA’s requirements, supporting continued market access in Brazil.

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