The registration process for a Class I medical device with Brazil’s National Health Surveillance Agency (ANVISA) follows a streamlined pathway due to the device's low-risk nature. Below are the detailed steps:

1. Classify the Device

• Verify that your product qualifies as Class I under ANVISA’s classification system. Class I devices are low-risk and have minimal impact on patient health if they fail.

2. Appoint a Brazilian Registration Holder (BRH)

• Foreign manufacturers must have a local entity, known as the Brazilian Registration Holder (BRH), to act as their representative with ANVISA. The BRH will submit the application and serve as the point of contact for regulatory matters.

3. Prepare the Device Dossier

• For Class I devices, the documentation requirements are lighter compared to higher-risk classes, focusing on safety, functionality, and labeling. The dossier typically includes:
  • Device Description: A summary of the device's function, materials, and intended use.
  • Labeling and Instructions for Use: Clear and concise instructions, warnings, and usage information in Portuguese.
  • Quality Management System (QMS) Documentation: Proof of QMS compliance, often ISO 13485 certification, demonstrating that the manufacturing process meets quality standards.

4. Assemble the Technical File

• Organize the documentation according to ANVISA’s requirements, ensuring it is complete and accurate. The technical file should be formatted for ANVISA’s submission portal and typically includes:
  • Evidence of compliance with Brazilian safety and performance standards.
  • Certificates of analysis, if applicable, and any validation data.
  • Translations of critical documents into Portuguese, as required by ANVISA.

5. Submit the Application through the ANVISA System

• Submit the dossier electronically through ANVISA’s digital platform. The BRH handles this submission, including uploading the application and all necessary documents.

6. Pay the Registration Fee

• Pay the applicable fee for Class I devices. Fees depend on the type of registration and the applicant's company size. Payment confirmation is essential to start ANVISA's review process.

7. ANVISA Review and Approval

• ANVISA will review the application for completeness, ensuring that the device meets all safety and performance standards. Class I devices generally follow an expedited review process, so approvals may take only a few weeks to a few months, depending on ANVISA’s current workload.

8. Post-Approval Obligations

• Once the device is approved, it is listed in the ANVISA database and can be legally marketed in Brazil. Class I registrations are valid for five years, after which renewal is required.
• Adhere to post-market surveillance requirements, such as tracking adverse events and maintaining records on device performance and safety.

Tips for a Successful Application:

• Work with a Knowledgeable BRH: A well-informed Brazilian Registration Holder can help navigate local requirements and prevent common submission errors.
• Ensure Documentation Accuracy: Double-check the accuracy of all documents to avoid delays, particularly translations.
• Keep Updated on Regulatory Changes: ANVISA regulations may change, and staying current with updates is essential for compliance.

Following these steps carefully can help facilitate a smooth approval process and successful market entry into Brazil.