Before applying for Class I medical device registration with Brazil ANVISA, taking careful preparatory steps can greatly streamline the registration process. Here’s a checklist of essential preparatory steps:

1. Confirm Device Classification

• Determine Risk Class: Ensure that your device is indeed Class I (low-risk). This classification is based on the intended use, level of invasiveness, and duration of contact with the human body.
• Reference ANVISA Guidelines: Use ANVISA’s RDC 185/2001 classification guidance to verify the correct classification. Misclassifying the device could lead to delays or additional requirements.

2. Identify Brazilian Registration Holder (BRH)

• Appoint a BRH: Non-Brazilian manufacturers must appoint a Brazilian Registration Holder (BRH), who will act as the official local representative.
• BRH Responsibilities: The BRH is responsible for submitting the application, communicating with ANVISA, and managing post-market surveillance in Brazil.
• Legal Agreement: Formalize a legal agreement with the BRH, clearly defining roles, responsibilities, and obligations.

3. Prepare Technical Documentation

• Compile a Technical Dossier: Gather essential technical documents, including device description, labeling, risk management files, and instructions for use (IFU).
• Language Requirement: Ensure all documentation, including IFUs and labeling, is translated into Portuguese to meet ANVISA requirements.
• Labeling Compliance: Check that the device labeling meets ANVISA’s requirements per RDC 185/2001. Labels must include product name, model, manufacturing and expiration dates, BRH contact details, and usage instructions.

4. Implement Quality Management System (QMS)

• ISO 13485 Compliance: Although not always mandatory for Class I devices, having an ISO 13485-compliant QMS is highly recommended. This helps demonstrate commitment to quality management and regulatory standards.
• Documentation of Procedures: Ensure that the QMS documentation includes design controls, manufacturing procedures, and risk management aligned with ISO 14971.
• Manufacturing Facility Compliance: Make sure the manufacturing facility meets Brazilian and international GMP standards to facilitate potential inspections or audits by ANVISA.

5. Conduct Risk Management Analysis

• Risk Assessment per ISO 14971: Complete a risk assessment of the device according to ISO 14971 standards. Identify potential hazards, assess risks, and outline mitigation measures.
• Document Risk Controls: Ensure all risk controls are documented, as ANVISA requires evidence that potential risks have been identified and managed.

6. Review Biocompatibility and Safety Testing

• Biocompatibility (ISO 10993): If the device has direct or indirect contact with the human body, prepare biocompatibility test results according to ISO 10993 standards.
• Electrical and Mechanical Safety (if applicable): For devices with electrical or mechanical components, ensure safety testing complies with IEC 60601-1 standards.
• Sterilization Validation (if applicable): If the device is sterile, perform and document sterilization validation in accordance with ISO 11607 for packaging and sterility.

7. Gather Regulatory Compliance Evidence

• Declaration of Conformity (DoC): Prepare a Declaration of Conformity, affirming that the device meets applicable Brazilian standards and international regulations.
• Product Testing Reports: Ensure any testing reports demonstrating device safety, performance, and efficacy are up-to-date and available.
• Material Safety Data Sheets (MSDS): If the device contains hazardous materials, include MSDS documentation to show safe handling and usage practices.

8. Prepare Market-Specific Documents

• Translate All Documents to Portuguese: Ensure all necessary documentation, such as technical files, labels, and IFUs, is translated into Portuguese to comply with Brazilian regulatory requirements.
• Localize IFUs and Labels: Instructions for use, warnings, and labels should be adapted for the Brazilian market, using standardized symbols if necessary to improve clarity.

9. Establish Post-Market Surveillance Procedures

• Complaint Handling and Adverse Event Reporting: Set up a system to manage customer complaints and report adverse events to ANVISA.
• Post-Market Monitoring Plan: Develop a post-market surveillance plan to ensure ongoing safety and efficacy. The plan should outline processes for collecting and analyzing data from the Brazilian market.

10. Budget for Registration Costs and Timelines

• Registration and Renewal Fees: Calculate registration fees, including potential costs for translations, BRH services, and post-market obligations.
• Timeline Planning: ANVISA Class I registrations may take a few months to process, so plan your submission timing accordingly. Consider the 5-year registration validity and prepare for renewal.

11. Conduct a Final Review and Pre-Submission Checklist

• Verify Completeness of Documentation: Ensure that all required documents are complete, accurate, and organized per ANVISA’s structure. Missing or incorrect information can lead to delays or rejections.
• Confirm Compliance with ANVISA’s Standards: Make sure that all aspects of the device, from manufacturing to risk management, are in compliance with Brazilian regulatory standards.

By carefully preparing these elements before submitting the application, you can improve your chances of a successful and timely registration with ANVISA. This preparation also establishes a strong foundation for compliance throughout the product’s lifecycle in the Brazilian market.

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