Class I medical device registration with Brazil’s National Health Surveillance Agency (ANVISA) is a regulatory process designed for low-risk medical devices. These devices require a simpler registration pathway due to their low-risk nature, and this is often referred to as "Cadastro" (registration) rather than "Registro" (higher scrutiny, applicable for higher-risk devices). Here’s a breakdown of Class I device registration and how to apply:

What is Class I Medical Device Registration with ANVISA?

Class I devices are categorized as low-risk products under ANVISA’s classification system. These are typically items that have minimal impact on patient health if they fail, and they don't require extensive testing or documentation like higher-risk (Class II, III, or IV) devices. Typical Class I devices may include simple surgical instruments, certain patient aids, or low-complexity equipment.

Steps to Apply for Class I Medical Device Registration with ANVISA

1. Identify Device Classification:

   • Confirm that the product qualifies as a Class I device under ANVISA’s risk classification. Brazil follows a classification system similar to the EU (Class I, II, III, and IV).

2. Obtain a Brazilian Registration Holder (BRH):

   • Foreign manufacturers must appoint a Brazilian Registration Holder (BRH) to represent them with ANVISA. This local representative acts as the official liaison with ANVISA.

3. Prepare Required Documentation:

   • For Class I devices, ANVISA requires a dossier with basic information and technical documentation. Key documents include:
     • Device Description: Information on device design, components, materials, and purpose.
     • Instructions for Use and Labeling: A comprehensive guide on how the device should be used safely.
     • Quality Management System (QMS): Proof of QMS compliance, often with ISO 13485 certification, though Brazil-specific documentation may also be required.

4. Complete the Dossier:

   • ANVISA requires a device dossier tailored to the product’s risk class. For Class I, the documentation is lighter and focuses on demonstrating safety and effectiveness.

5. Submit the Registration Application via the ANVISA System:

   • Submissions are made electronically through ANVISA’s platform. The BRH will submit the required dossier along with the application form.

6. Pay the Applicable Fees:

   • Fees vary based on device class and company size. Fees for Class I are generally lower than those for higher-risk devices.

7. ANVISA Review and Approval:

   • ANVISA will review the dossier, ensuring the device meets all safety and labeling standards. For Class I devices, this is a streamlined process that typically takes less time than higher-risk classes, though timelines may vary.

8. Obtain Approval and Register the Device:

   • Once approved, the device is listed with ANVISA and can be marketed in Brazil. Registration must be renewed every five years.

9. Post-Market Obligations:

   • Maintain compliance with ANVISA's post-market surveillance requirements, which include reporting adverse events and device performance monitoring.

Tips for a Smooth Registration Process

• Collaborate with a Local Partner: Working with a reliable Brazilian Registration Holder simplifies communication with ANVISA.
• Ensure Document Accuracy: Verify that all documentation is complete and accurate to avoid delays during ANVISA's review.
• Stay Informed on ANVISA’s Regulations: Brazil's regulatory requirements can change, so staying up-to-date with ANVISA's guidelines is crucial.

For further guidance, ANVISA offers resources on its website, or a local regulatory expert can provide personalized assistance through the registration process.

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