The application procedures for Class I medical device registration with Brazil ANVISA involve a series of steps, which are generally simpler than for higher-risk medical devices. Since Class I devices are low-risk, they follow the Cadastro (Notification) Pathway under Brazil’s medical device regulations. Below is a detailed breakdown of the procedures:

Step 1: Confirm the Device Classification

• Class I Verification: Ensure your medical device qualifies as Class I under ANVISA’s classification criteria. Class I devices are low-risk, and the classification is typically based on the intended use and the device's level of risk.
• Reference Regulation: The classification can be checked against RDC 185/2001, which outlines how devices are classified in Brazil.

Step 2: Appoint a Brazilian Registration Holder (BRH)

• BRH Requirement: Foreign manufacturers must appoint a Brazilian Registration Holder (BRH) to act as the local representative for regulatory purposes. The BRH will handle all interactions with ANVISA, including the submission of the registration application.
• BRH Legal Agreement: The BRH must sign a legal agreement with the manufacturer, outlining responsibilities, liabilities, and obligations for post-market activities.

Step 3: Gather the Required Documentation

• Technical Documentation: For Class I devices, the documentation requirements are minimal, but certain documents are necessary for registration:
  • Product Description: Basic details about the device, including its intended use, specifications, and any features.
  • Labeling and Packaging Information: Include copies of the device’s labels, packaging, and Instructions for Use (IFU) in Portuguese, as required by ANVISA. The language requirement is crucial for compliance.
  • Manufacturing Information: Provide details about the manufacturing site, including proof of compliance with quality standards (e.g., ISO 13485 if applicable).
  • Risk Management Documentation: A brief overview of risk management, typically following ISO 14971.
• Document Translation: Ensure all documents submitted to ANVISA are translated into Portuguese.

Step 4: Submit the Application to ANVISA

• ANVISA’s Online System: The BRH submits the application through ANVISA’s online platform (SNGPC). This system is used for the Cadastro (notification) process.
• Document Upload: Upload all required documents (product details, labeling, IFU, manufacturing details, etc.) to the online platform.
• Application Fee: The BRH will pay the application fee as part of the submission process. The fee for Class I registration is typically lower than for higher-risk devices.

Step 5: ANVISA Review

• Initial Review: ANVISA will review the submission to ensure that all required documents are complete and meet regulatory requirements.
• Compliance Check: ANVISA will verify that the device is classified correctly, labeling is in Portuguese, and all relevant quality standards are met.
• Approval or Request for Additional Information: If ANVISA finds that the application meets the regulatory standards, the registration will proceed. If there are any issues, ANVISA may request additional information or clarification.

Step 6: Approval and Issuance of Cadastro Registration Number

• Issuance of Cadastro Number: Upon approval, ANVISA will issue a Cadastro Registration Number, which authorizes the device for sale in Brazil. This registration is valid for five years.
• Notification to the BRH: The BRH will receive confirmation of registration, and they will be responsible for ensuring compliance with post-market obligations.

Step 7: Post-Approval Compliance

• Labeling and Packaging: Ensure that the device’s labeling and packaging are compliant with Brazilian regulations (including Portuguese language requirements).
• Post-Market Surveillance: The manufacturer (through the BRH) must establish a system for handling complaints, adverse events, and product recalls. RDC 67/2009 governs post-market surveillance and vigilance requirements.
• Maintenance of Quality Standards: Ensure that the device continues to comply with relevant ISO standards and local regulations.
• Renewal: The registration is valid for five years, and a renewal application must be submitted before the expiration date.

Summary of Application Procedures for Class I Medical Device Registration with Brazil ANVISA

1. Verify Device Classification: Confirm that the device qualifies as Class I under RDC 185/2001.
2. Appoint a BRH: Foreign manufacturers must engage a Brazilian Registration Holder.
3. Prepare Documentation: Gather product description, labeling, packaging, manufacturer details, and risk management information.
4. Submit Application: The BRH submits the application through ANVISA’s online system (SNGPC).
5. ANVISA Review: ANVISA reviews the application and checks for compliance.
6. Approval and Registration Number: If approved, ANVISA issues a Cadastro registration number.
7. Post-Approval Compliance: Ensure compliance with labeling, packaging, and post-market surveillance requirements.

By following these steps, you can successfully navigate the process to register your Class I medical device with ANVISA and obtain the necessary approval for sale in Brazil.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn