To apply for Class I medical device registration with ANVISA (Brazilian Health Regulatory Agency), you must follow a structured process. Class I devices are considered low-risk, and the registration process is simpler compared to higher-risk devices. Below is a detailed step-by-step guide on how to apply for registration:

Step-by-Step Process for Class I Medical Device Registration with ANVISA

1. Verify Device Classification

Before beginning the registration process, confirm that your device qualifies as a Class I medical device under ANVISA's classification system. Class I devices are typically low-risk and non-invasive, such as simple diagnostic equipment or surgical instruments that do not come into direct contact with the body.

• Regulations to review:
  • RDC 16/2013 for device classification.
  • RDC 185/2001 for medical device registration.

2. Appoint a Local Representative (if applicable)

If you are a foreign manufacturer, you are required to have a local representative in Brazil who will act as the contact point with ANVISA. This representative is usually an importer or distributor authorized to submit applications to ANVISA and ensure compliance with Brazilian regulations.

3. Prepare Required Documentation

Prepare the necessary documentation for the registration. ANVISA requires the following materials for Class I medical device registration:

• Application Form: Complete the ANVISA registration form via the e-PL (Electronic Process) system.
• Product Description and Technical File:
  • General description of the device, including its intended use and technical specifications.
  • Manufacturing process, quality control measures, and risk management documentation (if applicable).
  • A list of the device’s components and materials.
• Labeling: Submit labeling materials in Portuguese, which include:
  • Device name, manufacturer details, and intended use.
  • Instructions for use (IFU) and warnings/contraindications.
  • Expiry date (if applicable), lot numbers, and packaging information.
• Quality Management System (QMS): Provide proof of compliance with Good Manufacturing Practices (GMP) or certification such as ISO 13485, if applicable. This may be required if the device is manufactured or assembled in Brazil.
• Certificate of Free Sale: If the device is imported, you will need to provide a Certificate of Free Sale from the country of origin.
• Authorization to Import: If the device is imported, the importer must provide authorization for importation.

4. Submit the Application

The application is submitted via ANVISA's e-PL (Electronic Process) system. Here’s how to proceed:

1. Register on the e-PL system (if you do not already have an account).
2. Submit the application: Complete the form and upload all the required documents in digital format.
3. Translate documents into Portuguese: Ensure all supporting documents, including the device’s labeling, instructions for use, and technical file, are in Portuguese as required by ANVISA.
4. Pay the registration fee: ANVISA charges a fee for registration, which varies depending on the device’s classification.

5. Application Review

Once submitted, ANVISA will begin the documentary review process. This step involves checking that the application is complete and the device complies with Brazilian regulations. The review includes:

• Verifying that the documentation is complete.
• Ensuring the device complies with local regulations for Class I medical devices.
• Reviewing the labeling, technical file, and GMP/QMS certification (if applicable).

For Class I devices, this review is generally straightforward, as these devices are low-risk and don’t require clinical trials or extensive technical testing.

6. Request for Additional Information (if necessary)

If ANVISA finds discrepancies or missing information in the application, they will request clarification or additional documents. Ensure that you respond promptly to avoid delays in the registration process.

7. Registration Approval

If ANVISA finds the submission to be complete and compliant, they will approve the registration and issue a registration certificate (Cadastro). This certificate is necessary to market and sell the medical device in Brazil.

8. Post-Registration Requirements

Once registered, the Class I device can be marketed in Brazil. However, there are some post-registration requirements:

• Post-market surveillance: You must monitor the device’s performance in the market and report any adverse events or safety issues to ANVISA as required by RDC 55/2010.
• Amendments to the Registration: If there are any changes to the device (e.g., new versions, changes in manufacturing), you may need to submit an amendment to the registration.
• Importation: The registered device must be cleared by Brazilian customs for importation before it can be distributed in Brazil.

Summary of the Registration Process

1. Verify device classification (Class I).
2. Appoint a local representative (for foreign manufacturers).
3. Prepare required documentation (technical file, labeling, QMS, GMP proof).
4. Submit the application via the e-PL system.
5. ANVISA review of submitted documents.
6. Additional information (if requested by ANVISA).
7. Approval and registration: ANVISA issues the registration certificate.
8. Post-market compliance: Follow post-market surveillance and amendment requirements.

Timeline

• The registration process for Class I medical devices generally takes around 1 to 3 months from submission to approval, depending on how quickly ANVISA processes the documents and whether any additional information is requested.

By following these steps, you can successfully apply for Class I medical device registration with ANVISA and ensure compliance with Brazilian regulations.

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