To apply for Class I medical device registration with Brazil’s National Health Surveillance Agency (ANVISA), the application must be submitted through ANVISA's e-Submission System. The system is called SNGPC (Sistema de Notificação de Produtos de Saúde), which is used for registering health products, including medical devices, in Brazil.

Steps to Apply for Class I Medical Device Registration:

1. Create an Account with ANVISA's e-Submission System (SNGPC):

   • You need to create a user account on ANVISA’s digital platform to submit your application. This account is typically created by the Brazilian Registration Holder (BRH) if you are a foreign manufacturer.
   • Link to ANVISA's Portal: ANVISA Portal for Registration (You may need a Portuguese-language interface for detailed navigation).

2. Appoint a Brazilian Registration Holder (BRH):

   • Foreign manufacturers must have a Brazilian Registration Holder (BRH) who will submit the registration application on their behalf. The BRH will act as your representative in Brazil and handle all communications with ANVISA.

3. Prepare and Submit the Application:

   • The BRH will need to upload the necessary documentation, which includes the device description, labeling, instructions for use, QMS proof (e.g., ISO 13485), and other relevant documents to the SNGPC system.
   • For Class I devices, the application is often simpler, but must still meet ANVISA’s regulatory requirements for safety and performance.

4. Track the Application Status:

   • Once submitted, the BRH can track the application status through the system. ANVISA may request additional information if necessary.

5. Pay Registration Fees:

   • Fees must be paid via ANVISA's platform. The payment is typically processed through a bank or payment system associated with ANVISA. Once payment is confirmed, the application will proceed with ANVISA's review.

Key Links:

• ANVISA Website: ANVISA Official Website
• SNGPC Access: The system is integrated within the ANVISA portal and requires the BRH to access the submission platform.

If you're a foreign company, your Brazilian representative (BRH) will handle most of this process, including submitting the application and communicating with ANVISA on your behalf. Make sure that all documents are in compliance with ANVISA's requirements to avoid delays.