To apply for Class II medical device registration with ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil, you will need to use ANVISA's online platform. Here’s how you can go about the application process:

Online Application Portal

1. e-ANVISA Platform:

   • Applications for medical device registration must be submitted through ANVISA's electronic system known as e-ANVISA.
   • You can access the portal here: e-ANVISA.

2. Creating an Account:

   • If you do not already have an account, you will need to create one on the e-ANVISA platform. This account will allow you to submit applications and track the status of your submission.

3. Submission Process:

   • Log in to your e-ANVISA account.
   • Fill out the required application forms for medical device registration, ensuring that all necessary information and documentation are provided.
   • Upload the complete technical documentation and any other required materials.

4. Follow Guidelines:

   • Make sure to follow ANVISA’s guidelines and templates for submitting documentation. ANVISA provides specific instructions and checklists to help you prepare a complete application.

Additional Steps

• Consult ANVISA’s Documentation: Familiarize yourself with ANVISA’s official documentation, including guidance documents related to Class II medical device registration. This information can often be found on their website or through the e-ANVISA platform.

• Legal Representation: If you are an international applicant, ensure you have a Brazilian legal representative who can act on your behalf throughout the registration process.

Contact ANVISA for Assistance

• If you have questions or need further assistance during the application process, you can contact ANVISA directly through their website or customer service channels for guidance.

Useful Links

• ANVISA Official Website: ANVISA Website
• e-ANVISA Portal: e-ANVISA

By following these steps and utilizing the e-ANVISA platform, you can effectively apply for Class II medical device registration in Brazil. If you need more specific information or help with any part of the process, feel free to ask!