Registering a Class I medical device with Brazil’s National Health Surveillance Agency (ANVISA) involves a streamlined process given that Class I devices are low-risk. Here are the primary steps:

1. Identify Device Classification:

   • Confirm that the device qualifies as Class I under ANVISA’s classification system. This is essential since different classes follow different registration pathways.

2. Obtain Brazilian Registration Holder (BRH):

   • Only local companies can submit applications to ANVISA. If your company isn’t based in Brazil, you’ll need a Brazilian Registration Holder (BRH) or representative.

3. Prepare Documentation:

   • Required documents include:
     • Letter of Authorization: If you’re using a local representative, authorize them to represent your product in Brazil.
     • Technical Documents: Device description, intended use, instructions for use, labeling, and technical data.
     • Quality Management System (QMS) Compliance: For Class I, provide proof of QMS compliance, often based on ISO 13485 certification.

4. Prepare the Dossier:

   • The dossier for Class I is usually simpler than higher classes, focusing on safety and functionality. The documentation should align with ANVISA’s regulations, including general safety and performance requirements.

5. Submit via the Brazilian Unified Health System (SUS):

   • Class I devices may be eligible for simplified registration. Submit the application, including all required documents, through the electronic system.

6. Fees:

   • Pay the registration fee. The amount depends on the device classification and the applicant company size.

7. ANVISA Review and Approval:

   • ANVISA reviews the submission, which typically takes less time than higher-risk classes. For Class I, the process may take a few weeks to a few months, depending on ANVISA’s current workload.

8. Post-Approval Requirements:

   • After approval, you must comply with post-market surveillance requirements and renew the registration every five years.

Navigating ANVISA requirements can be complex, and working with a knowledgeable local partner can help ensure a smoother process.

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