To obtain Class I medical device registration with Brazil ANVISA, you’ll follow a streamlined Cadastro (notification) process, which is simpler than the full registration required for higher-risk devices. Below are the steps to guide you through obtaining registration:

1. Verify Device Classification

• Confirm Class I Classification: Ensure your device is classified as Class I (low-risk) under ANVISA’s classification system. Use RDC 185/2001 to check the classification criteria for low-risk devices.

2. Appoint a Brazilian Registration Holder (BRH)

• Partner with a Local Representative: Foreign manufacturers must have a Brazilian Registration Holder (BRH). The BRH is responsible for submitting and managing the registration process and acting as the liaison with ANVISA.
• Legal Agreement with BRH: Formalize the relationship with a contract, as the BRH will handle regulatory communications, post-market obligations, and renewals.

3. Prepare Required Documentation

• Compile Technical Documentation: While Class I devices require minimal documentation, ANVISA still expects some key documents:
  • Product Description: Include details about the device’s intended use, functions, and main specifications.
  • Labeling and Instructions for Use (IFU): Provide the device’s labels, packaging, and usage instructions. All information must be in Portuguese to comply with Brazilian regulations.
  • Manufacturer Information: Include details about the manufacturing site, including evidence of the quality management system (QMS), such as ISO 13485 certification.
  • Risk Management Document: Although simplified for Class I devices, provide a basic risk management summary per ISO 14971 guidelines.
• Translate Documents into Portuguese: All documents submitted to ANVISA must be in Portuguese.

4. Submit the Application through ANVISA’s Online System

• Register the Device under Cadastro: The BRH submits the device for Cadastro (notification) through ANVISA’s online system (SNGPC). The Cadastro pathway is intended for low-risk devices like Class I, so fewer technical details are required.
• Upload Documents and Pay Fees: The BRH uploads the required documents and pays the registration fee, which is typically lower for Class I devices than for higher classifications.

5. Await ANVISA Review and Approval

• Review Process: ANVISA reviews the application to ensure that all regulatory and documentation requirements are met. For Class I devices, this review is often quicker and less stringent than for higher-risk devices.
• Cadastro Registration Number Issuance: If the application meets ANVISA’s requirements, a Cadastro registration number is issued, allowing the device to be legally marketed in Brazil.

6. Post-Approval Compliance

• Labeling and Packaging: Ensure all labeling, packaging, and IFU materials comply with RDC 185/2001, and all must be in Portuguese.
• Post-Market Surveillance (PMS): Establish a system for post-market surveillance, including a process for tracking adverse events and managing any product complaints.
• Quality Compliance Maintenance: Maintain adherence to QMS standards, even if ANVISA does not require in-depth audits for Class I devices.
• Registration Renewal: Remember that the registration is valid for five years, and a renewal application must be submitted before it expires to keep the product on the market.

Summary Checklist for Obtaining Class I Medical Device Registration with ANVISA

1. Verify Class I Classification: Check RDC 185/2001.
2. Appoint a BRH: Establish a legal agreement with a Brazilian Registration Holder.
3. Prepare Documentation: Collect the product description, labeling, manufacturer details, and basic risk management information.
4. Submit Cadastro Application: BRH submits the application through ANVISA’s online system.
5. Approval and Registration Number: Receive the Cadastro registration number for legal marketing.
6. Post-Market Obligations: Maintain PMS, ensure labeling compliance, and renew registration every five years.

Following these steps will ensure a smooth and efficient registration process, enabling you to legally market your Class I device in Brazil.