To register and apply for Class I medical device registration with Brazil ANVISA, you will need to follow a clear process outlined by the Brazilian Health Regulatory Agency (ANVISA). Class I devices are low-risk and typically follow a Cadastro (Notification) procedure, which is simpler than the more complex registration processes for higher-risk devices. Here’s a step-by-step guide to help you through the application process:

Step 1: Determine Device Classification

• Class I Classification: Confirm that your device qualifies as Class I under ANVISA’s classification system. Class I devices are considered low-risk, and they follow simplified regulatory procedures.
• Regulatory Reference: Refer to RDC 185/2001 to verify the classification of your device. Class I devices include items such as simple surgical instruments, bandages, and other non-invasive, low-risk products.

Step 2: Appoint a Brazilian Registration Holder (BRH)

• BRH Requirement: If your company is based outside Brazil, you must appoint a Brazilian Registration Holder (BRH). The BRH is a local entity (either a representative or distributor) responsible for handling the registration process with ANVISA and for ensuring post-market compliance.
• Legal Agreement: A formal agreement must be in place between the manufacturer and the BRH, outlining their responsibilities and obligations for product registration and market oversight.

Step 3: Prepare the Required Documentation

• Technical Documentation: For Class I medical devices, the documentation requirements are relatively straightforward, but you’ll need to provide the following:
  1. Product Description: A detailed description of the device, its intended use, and its functions.
  2. Labeling: Provide a copy of the device’s labeling and packaging materials in Portuguese. This must include information such as product name, intended use, warnings, and instructions for use (IFU).
  3. Manufacturing Information: Information about the manufacturing site(s), including proof of a quality management system (e.g., ISO 13485 certification) if applicable.
  4. Risk Management: A basic risk management document, generally in accordance with ISO 14971, demonstrating how potential risks are mitigated for the device.
• Document Translation: All documents must be translated into Portuguese to comply with ANVISA’s requirements.

Step 4: Submit the Application to ANVISA

• Online Submission via SNGPC: The BRH will submit the application for registration via ANVISA’s online system (SNGPC), which is used to manage device registration and approval.
• Required Documents: The BRH will upload the necessary documentation (product details, labeling, manufacturer info, risk management, etc.) into the system.
• Payment of Fees: The BRH will also handle the payment of registration fees, which vary depending on the type of medical device and its classification. For Class I devices, the fees are typically lower.

Step 5: ANVISA Review and Evaluation

• Application Review: ANVISA will review the submitted application to ensure it meets regulatory requirements, including compliance with labeling, product description, and risk management standards. The review is generally faster for Class I devices because they are considered low-risk.
• Request for Clarification: If any documents are incomplete or unclear, ANVISA may request additional information or clarification. Ensure that all documents are thorough to avoid delays.

Step 6: Cadastro Approval and Registration Number Issuance

• Cadastro Registration: If ANVISA approves the application, it will issue a Cadastro (notification) registration number, which authorizes the device to be marketed in Brazil. This is typically a five-year registration.
• BRH Notification: Once the registration is issued, the BRH will be notified of the approval and can begin to distribute and sell the device in Brazil.

Step 7: Post-Approval Obligations

• Labeling Compliance: Ensure that all labeling, packaging, and Instructions for Use (IFU) comply with ANVISA’s requirements, including the use of Portuguese language.
• Post-Market Surveillance: The BRH must establish a system for post-market surveillance, which includes reporting any adverse events, complaints, or product recalls.
• Quality System Maintenance: If the device is manufactured under a quality management system like ISO 13485, you should continue to maintain this system for ongoing compliance.
• Renewal: Class I registrations are valid for five years. The registration must be renewed before it expires to continue marketing the device in Brazil.

Summary of the Application Procedure

1. Verify Device Classification: Ensure the device qualifies as Class I under ANVISA's guidelines (RDC 185/2001).
2. Appoint a BRH: A local representative or distributor must handle the registration process in Brazil.
3. Prepare Documentation: Collect and translate the product description, labeling, manufacturing information, and risk management details.
4. Submit Application via SNGPC: The BRH submits the application and pays the required fees.
5. ANVISA Review: ANVISA reviews the application and may request additional information.
6. Cadastro Registration: Once approved, ANVISA issues a Cadastro registration number.
7. Post-Approval Compliance: Ensure labeling, surveillance, and quality system requirements are maintained.

By following these steps, you can successfully register your Class I medical device with Brazil ANVISA and ensure compliance with local regulations for marketing the device in Brazil.

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