For Class I medical device registration with ANVISA in Brazil, several materials and documents must be prepared to ensure compliance with Brazilian regulations. These documents will be submitted electronically via ANVISA’s e-PL system. Below are the required materials and guidelines on how to prepare the application documents:

Required Materials for Class I Medical Device Registration

1. Product Description

• Device Name and Category: A clear description of the device, its name, and category.
• Intended Use: An explanation of the intended medical application and user population.
• Design and Functionality: A description of the design, materials used, and how the device functions.
• Regulatory Status: Information on whether the device is registered in other countries (if applicable).

2. Technical Documentation

The technical documentation provides detailed information on the device’s design, safety, and performance. For Class I devices, the documentation is usually less extensive than for higher-risk devices but still must include the following:

• Risk Management:
  • A basic risk analysis or a simplified risk management report for the device. This can be based on ISO 14971 (Risk management for medical devices).
  • Identify and mitigate potential risks related to the device's use.
• Performance and Safety Data:
  • Any available testing data or performance results that demonstrate the device’s safety and effectiveness.
  • If the device is invasive or comes into contact with patients, more detailed testing may be required, though this is less common for Class I devices.
• Materials Information:
  • A list of all materials used in the device, demonstrating that they are safe and suitable for the intended use (e.g., biocompatibility testing for materials in contact with the body).

3. Labeling and Instructions for Use (IFU)

• Product Labeling: Labeling must comply with ANVISA’s requirements and should include:
  • Manufacturer’s name and address.
  • Device name and description.
  • Intended use of the device.
  • Instructions for use, including proper operation and any warnings, precautions, or contraindications.
  • The CE mark or any other certification logos if applicable.
  • Expiration date, if necessary (for devices with a shelf-life).
• Instructions for Use (IFU): A document explaining how to properly use the device. It should include:
  • Step-by-step instructions.
  • Safety precautions.
  • Maintenance instructions, if applicable.

4. Good Manufacturing Practices (GMP) Compliance

• If the device is manufactured outside Brazil, the manufacturer must demonstrate compliance with Good Manufacturing Practices (GMP).
  • ISO 13485 certification (or equivalent) is commonly required.
  • Documentation proving that the device is manufactured in accordance with these standards must be included.

5. Proof of Conformity with International Standards (if applicable)

• If available, submit documents such as:
  • ISO 13485 (Quality Management System).
  • ISO 14971 (Risk Management).
  • Any other relevant certifications from accredited bodies that show the device meets international standards.

6. Local Representative Documentation (For Foreign Manufacturers)

• If the manufacturer is located outside Brazil, the local representative (a Brazilian entity) must be identified, and their contact details should be provided.
• The local representative must be authorized to submit the application on behalf of the manufacturer and handle communication with ANVISA.

Required Documents for the Local Representative:

• A power of attorney from the manufacturer, authorizing the local representative to act on their behalf.
• A declaration that the local representative will ensure post-market compliance (e.g., adverse event reporting).

7. Other Documentation

• Certificate of Free Sale: This is a document that proves the device is legally sold and used in the country of origin (if applicable).
• Conformity Declaration: A signed declaration by the manufacturer stating that the device complies with Brazilian regulations and international standards.

How to Prepare the Application Documents

1. Organize the Documentation: All documents must be clear, organized, and complete. Ensure the following:

   • All documents must be in Portuguese. If documents are in another language, official translations are required.
   • The technical documentation should be well-structured and easy to follow, with clear references to relevant standards (e.g., ISO 13485, ISO 14971).
   • Labeling and instructions must be translated into Portuguese and comply with ANVISA’s requirements.

2. Create an Account in the e-PL System:

   • The registration process must be completed through ANVISA’s e-PL (Sistema Eletrônico de Peticionamento) system.
   • If the applicant is a foreign manufacturer, the local representative will handle the submission process.
   • Access the e-PL system at the official ANVISA website and create an account for submitting the registration.

3. Upload Documents via e-PL:

   • Once all documents are prepared and translated (if necessary), they should be uploaded to the e-PL system.
   • Each document needs to be submitted in the correct format (typically PDF) and in accordance with ANVISA’s guidelines.
   • Ensure all documents are clear, complete, and organized to avoid delays in the review process.

4. Pay the Registration Fees:

   • A fee must be paid to ANVISA to process the registration. The cost typically ranges between BRL 1,500 and BRL 3,000 for Class I devices. Check ANVISA’s fee schedule for the exact amount.

5. Track the Submission Status:

   • After submission, you can track the status of the application through the e-PL system.
   • ANVISA will review the application and may request additional documentation if needed.

Key Considerations

• Documentation Completeness: Ensure that all required documents are complete, accurate, and organized. Missing or incomplete documents may lead to delays.
• Local Representative: If the manufacturer is based outside Brazil, a local representative is mandatory. This representative must have a clear understanding of Brazilian regulations and be able to handle communications with ANVISA.
• Compliance with International Standards: Demonstrating compliance with international standards (like ISO 13485 and ISO 14971) can facilitate the registration process and may be required for higher-risk devices.
• Post-Market Surveillance: Once the device is registered, the manufacturer and local representative must comply with post-market surveillance requirements, including adverse event reporting and ensuring the device remains compliant with Brazilian regulations.

Summary of Required Materials for Class I Medical Device Registration with ANVISA:

1. Product Description and Intended Use.
2. Technical Documentation (Risk management, safety/performance data, materials).
3. Labeling and Instructions for Use (translated to Portuguese).
4. Good Manufacturing Practices (GMP) Compliance (ISO 13485 or equivalent).
5. Proof of Conformity with International Standards (if applicable).
6. Local Representative Documentation (for foreign manufacturers).
7. Other Documents (e.g., Certificate of Free Sale, Conformity Declaration).

By carefully preparing and submitting these materials through ANVISA’s e-PL system, you can successfully apply for Class I medical device registration in Brazil.

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