For Class I medical device registration with Brazil’s ANVISA, you need to prepare a series of materials and documents to ensure compliance with the regulatory requirements. Below is a detailed list of the materials required and how to prepare the application documents effectively.

Materials Required for Class I Medical Device Registration with ANVISA

1. Application Form

   • This form provides basic details about the device, the manufacturer, and the device registration. The form must be filled out through ANVISA’s e-Submission System (SNGPC).
   • The Brazilian Registration Holder (BRH), if the manufacturer is foreign, is responsible for submitting this form on behalf of the manufacturer.

2. Device Description

   • A detailed description of the device, including:
     • Intended use: What the device is designed to do.
     • Technical specifications: Key components, dimensions, materials, and design features.
     • Risk classification: Demonstrate that the device qualifies as Class I according to ANVISA’s classification system.
     • Design and functionality: How the device works and how it is used by healthcare professionals or patients.

3. Instructions for Use (IFU)

   • Clear and concise instructions on how to use the device safely and effectively.
   • The IFU must include:
     • Usage instructions in Portuguese.
     • Warnings, precautions, contraindications, and any special handling or storage instructions.
     • Indications for use: Specific medical conditions or purposes for which the device is intended.
     • Any limitations or restrictions in usage.

4. Labeling

   • The device must have appropriate labeling that adheres to ANVISA’s requirements. The label should include:
     • Product name and description.
     • Manufacturer name and address.
     • Device model or catalog number.
     • Lot number or serial number (if applicable).
     • Expiration date (if applicable).
     • Sterility information (if applicable).
     • Instructions for use (or a reference to the IFU).
     • Anvisa registration number (once registered).
     • Health warnings (if relevant).
   • The labeling must be in Portuguese.

5. Quality Management System (QMS) Documentation

   • For Class I devices, a basic Quality Management System (QMS) is required. While ANVISA may not always demand ISO 13485 certification for Class I devices, having a QMS in place is a common expectation.
   • ISO 13485 certification, or a similar QMS certification, demonstrates that the manufacturer follows standard operating procedures to ensure the safety and quality of the device.
   • If the manufacturer does not have an ISO 13485 certification, they may need to provide evidence of their internal quality control procedures.

6. Product Testing or Safety Documentation

   • Documentation regarding the device’s safety and performance may be required. This can include:
     • Safety tests: Data proving the device’s safety under normal use.
     • Electrical and mechanical testing: If the device is electronic, evidence of electrical safety is required.
     • Biocompatibility testing: For devices that contact the body, evidence of biocompatibility may be needed.
     • Sterilization validation: If applicable, documentation showing that the sterilization process is validated.

7. Authorization Letter for the Brazilian Registration Holder (BRH)

   • A letter authorizing the Brazilian Registration Holder (BRH) to represent the foreign manufacturer in the registration process. This letter must specify the scope of the BRH’s role and must be signed by the manufacturer’s authorized representative.

8. Declaration of Conformity

   • A statement confirming that the device complies with Brazilian regulatory requirements for medical devices, as outlined by ANVISA, and relevant international standards (e.g., ISO 13485, IEC standards).

9. Sterilization Documentation (if applicable)

   • If the device is sterilized, you must provide documentation on the sterilization process, including validation reports and sterilization methods used.

10. Additional Certifications or Regulatory Approvals

• If the device has been approved in other markets (e.g., the EU, USA, or other countries), including CE mark or FDA approval, these certifications can strengthen the registration application and demonstrate international compliance.

How to Prepare the Application Documents

1. Ensure Translation into Portuguese

   • All documents, including the Instructions for Use (IFU), labeling, and technical descriptions, must be translated into Portuguese. ANVISA requires all documentation to be in Portuguese to facilitate review.
   • It’s advisable to work with a professional translation service familiar with medical device terminology to ensure accuracy.

2. Organize the Documentation

   • Organize the documents in a structured format that adheres to ANVISA’s submission requirements. The technical file should be clear, complete, and consistent with all necessary supporting documents.
   • Typically, the BRH will submit these documents electronically via ANVISA’s SNGPC platform, ensuring they meet the specific requirements set by ANVISA.

3. Check for Compliance

   • Before submitting the documents, ensure that all the necessary information is included and that the device complies with the relevant Brazilian regulations. This includes ensuring that all labeling and instructional materials are in line with ANVISA’s requirements.
   • Verify that any certifications (e.g., ISO 13485, biocompatibility testing) are up-to-date and relevant to the device.

4. Electronic Submission

   • The BRH will submit the completed application and all required documentation via the SNGPC system. This platform allows for electronic submission of medical device applications and facilitates tracking the application status.

5. Payment of Fees

   • Pay the applicable registration fee via ANVISA’s online payment system. The fee can be paid after the submission of the application and is usually processed through SNGPC.

6. Follow-Up on Application Status

   • After submission, the BRH should monitor the application’s progress through SNGPC. ANVISA may request additional information, so prompt response is important to avoid delays.

Key Considerations

• Complete and Accurate Documentation: Incomplete or inaccurate documentation can delay the approval process. Double-check all required documents before submission.
• Local Representation: The BRH plays a crucial role in ensuring the process runs smoothly, so choosing a reliable local representative is important.
• Compliance with Brazilian Regulations: Be sure to meet the specific requirements of Brazilian health and safety standards.
• Post-Market Obligations: After approval, ensure compliance with ANVISA’s post-market surveillance and reporting requirements, such as adverse event reporting.

By preparing these materials carefully and ensuring all documents are in compliance, you can successfully navigate the Class I medical device registration process with ANVISA.

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