To apply for Class I medical device registration with ANVISA (Brazil's National Health Surveillance Agency), certain requirements must be met. These requirements ensure the device complies with safety and performance standards and follows regulatory guidelines in Brazil. Below are the key requirements for registering a Class I medical device:

1. Product Classification Confirmation

• Ensure Classification as Class I: Confirm that the device is indeed classified as a Class I medical device under ANVISA regulations. Class I devices are typically low-risk products, such as non-invasive medical devices.
• Reference Regulation: Refer to Resolution RDC 185/2001 for classification criteria and determine whether your product qualifies as a Class I device.

2. Technical Documentation

• Device Description: Provide a detailed description of the device, including its intended use, design, and functionality.
• Risk Management: Include a basic risk analysis document, often based on ISO 14971 (Risk management for medical devices). This demonstrates that risks associated with the device have been identified and controlled.
• Performance and Safety Data: Provide performance data or testing results (if necessary) that show the device meets safety requirements for its intended use.
• Materials Information: Detailed information on the materials used in the device, ensuring they are safe and suitable for the intended use.

3. Labeling and Instructions for Use

• Product Labeling: Submit the product labeling, which should include all required information such as:
  • Name and address of the manufacturer
  • Device name and description
  • Instructions for use
  • Warnings, precautions, and any contraindications
  • Expiry date, if applicable
• The labeling must comply with ANVISA’s requirements for medical device labeling in Brazil.

4. Manufacturer Information

• Manufacturer's Details: Provide information about the manufacturer, including the name, address, and contact details.
• GMP Compliance: If the manufacturer is located outside Brazil, you need to provide proof of compliance with Good Manufacturing Practices (GMP) or equivalent standards. If the device is manufactured according to international standards (e.g., ISO 13485), it should be documented.

5. Appoint a Local Representative

• Local Representation: If the manufacturer is outside Brazil, a local representative in Brazil is required. This representative will be responsible for submitting the application, handling communication with ANVISA, and ensuring compliance with local regulations.
• Local Representative’s Role: The local representative must:
  • Submit the registration application on behalf of the foreign manufacturer.
  • Act as the point of contact for ANVISA.
  • Handle post-market surveillance obligations.

6. Conformity with International Standards (if applicable)

• Standards Compliance: Demonstrate that the device conforms to recognized international standards (e.g., ISO 13485 for quality management or ISO 14971 for risk management).
• Certificates of Conformity: If available, submit certificates from accredited organizations that confirm the device meets these international standards.

7. Submit the Application via ANVISA’s e-PL System

• Electronic Submission: Applications are submitted through ANVISA’s electronic platform called e-PL. The application must include:
  • The technical documentation (including product description, labeling, risk analysis, etc.).
  • Proof of local representation (if the manufacturer is foreign).
  • Manufacturer’s GMP documentation and other required documents.
• All documentation should be submitted electronically in the prescribed format and in Portuguese, if necessary.

8. Administrative Fees

• Registration Fees: Payment of the required administrative fees is part of the submission process. The fee amounts vary and should be paid according to the official ANVISA guidelines.

9. Post-Market Surveillance Compliance

• Ongoing Compliance: After the device is registered, it must comply with post-market surveillance requirements, which include:
  • Reporting any adverse events or product-related issues.
  • Annual updates to ANVISA, if required.
  • Ensuring the device remains compliant with Brazilian regulations.
• Periodic Inspections: ANVISA may perform inspections to verify that the manufacturer adheres to safety and quality standards.

Summary of Key Requirements:

1. Confirmation of Class I classification under RDC 185/2001.
2. Technical documentation including device description, risk analysis, safety and performance data, and materials information.
3. Labeling and instructions for use that comply with Brazilian requirements.
4. Manufacturer's information, including proof of GMP compliance.
5. Appointment of a local representative (for foreign manufacturers).
6. Compliance with international standards (if applicable).
7. Submission via ANVISA’s e-PL system, including required documents.
8. Payment of applicable fees.
9. Post-market surveillance compliance.

By meeting these requirements and submitting the necessary documentation through the e-PL system, you can apply for Class I medical device registration with ANVISA in Brazil.