To apply for Class I medical device registration with ANVISA in Brazil, you must use the ANVISA electronic platform known as e-PL (Sistema Eletrônico de Peticionamento de Produtos para Saúde). This is the official system for submitting and managing medical device registration applications.

Where to Apply:

• ANVISA e-PL System: The application for Class I medical device registration must be submitted electronically through the e-PL system, which is ANVISA's online portal designed for medical device registration and approval in Brazil.
  • Website: You can access the e-PL system at ANVISA e-PL.
  • This portal allows manufacturers or their local representatives to create and submit registration requests, track the status of the application, and communicate with ANVISA.

Steps for Using the e-PL System:

1. Create an Account: First, the applicant (or the local representative, if the manufacturer is foreign) must create an account in the e-PL system.

2. Submit the Application: Once the account is set up, you can submit the registration application for the Class I medical device. This will include the required technical documentation, proof of local representation (if the manufacturer is foreign), and any additional required forms or fees.

3. Track the Application: After submission, you can track the status of the application through the e-PL system. If ANVISA requires additional information, the system will notify the applicant.

4. Approval and Registration Certificate: If the application is approved, ANVISA will issue a registration certificate through the e-PL system, which confirms that the device is approved for sale in Brazil.

Other Points of Contact:

• Local Representative: For foreign manufacturers, a local representative in Brazil must handle the registration process through the e-PL system. They will submit the application on behalf of the manufacturer and ensure that all regulatory requirements are met.

• Regulatory Consultants: If you're unsure about the registration process or need assistance with the e-PL system, regulatory consultants in Brazil can assist with navigating the process and ensuring that all documentation is correct.

Summary

• Where to Apply: The e-PL system on the official ANVISA website.
• URL: ANVISA e-PL Portal.
• For Foreign Manufacturers: A local representative must be appointed to manage the submission process.

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