To apply for Class I medical device registration with Brazil's ANVISA (Agência Nacional de Vigilância Sanitária), you must follow a defined process through ANVISA's digital submission system. Below is a detailed guide on how to apply for Class I medical device registration and where to proceed with it:

Step-by-Step Guide to Apply for Class I Medical Device Registration with ANVISA

1. Appoint a Brazilian Registration Holder (BRH)

• Foreign manufacturers must appoint a Brazilian Registration Holder (BRH). This is a local company or individual authorized to represent the foreign manufacturer in Brazil.
• The BRH will be responsible for submitting the application on your behalf, ensuring compliance with all Brazilian regulations, and handling any communications with ANVISA.

2. Prepare the Required Documentation

• Application Form: Filled out by the BRH on the ANVISA e-Submission system. This includes basic details about the device and the manufacturer.
• Device Description: Detailed information about the medical device (e.g., materials, design, intended use, and functionality).
• Instructions for Use (IFU): Must be in Portuguese, including safety, handling, and usage instructions.
• Labeling: Must meet ANVISA's requirements for labels, which should include manufacturer details, device name, model, batch number, expiration date, etc.
• Quality Management System (QMS): Proof of compliance with ISO 13485 or equivalent standards for Class I devices (although not always mandatory, it's recommended).
• Test Reports (if applicable): Safety or performance testing, including biocompatibility or electrical safety, depending on the device's nature.
• Authorization Letter for BRH: A letter signed by the foreign manufacturer appointing the BRH as the official representative.
• Declaration of Conformity: Statement that the device complies with Brazilian medical device regulations.

3. Submit the Application via ANVISA's e-Submission System (SNGPC)

• The BRH submits all the required documents electronically via ANVISA's online platform. The platform used for medical device registration is SNGPC (Sistema de Notificação de Produtos de Saúde).

  Link to SNGPC: ANVISA SNGPC Portal

4. Pay the Registration Fee

• After submission, the registration fee must be paid via the SNGPC system. Fees are generally lower for Class I devices and depend on the type of device, the company size, and the registration holder’s role. The BRH is responsible for handling the payment.

5. ANVISA Review Process

• Once the application is submitted, ANVISA will review the documentation. Since Class I devices are considered low-risk, the review process is generally faster than for higher-risk devices.
• If ANVISA requires additional information or clarification, they will contact the BRH.
• In general, the review process for Class I devices takes about 30 to 60 days.

6. Approval and Registration

• Once the application is approved, ANVISA will grant registration, and the device will be officially listed for sale and distribution in Brazil.
• The registration is valid for 5 years, after which renewal is required.

Where to Apply:

1. ANVISA Portal:

   • The application is processed through ANVISA's official portal for medical devices, specifically the SNGPC system.
   • You must create an account (if you don’t already have one) to access the system. The Brazilian Registration Holder (BRH) will complete the application and manage the submission.

2. Link to ANVISA’s Portal:

   • ANVISA Official Website
   • Through the ANVISA portal, you can access the SNGPC system where you will submit your registration.

3. BRH Involvement:

   • If you're a foreign manufacturer, you cannot submit the application directly to ANVISA. You need a Brazilian Registration Holder (BRH) who is authorized to act on your behalf.
   • The BRH will facilitate the submission, manage communication with ANVISA, and ensure compliance with all requirements.

Summary of the Application Process

• Step 1: Appoint a Brazilian Registration Holder (BRH).
• Step 2: Prepare the required documentation (device description, instructions for use, labeling, QMS certification, etc.).
• Step 3: Submit the application through ANVISA's SNGPC system.
• Step 4: Pay the registration fee.
• Step 5: ANVISA reviews the application and requests any additional information if necessary.
• Step 6: ANVISA approves and registers the device.

By following these steps and ensuring all documentation is in order, you can successfully register your Class I medical device with ANVISA and gain access to the Brazilian market.

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