Obtaining Class I medical device registration with Brazil’s National Health Surveillance Agency (ANVISA) involves meeting specific requirements due to the low-risk nature of these devices. Below are the key requirements to prepare for a successful registration:

1. Device Classification as Class I

• Verify that the medical device is appropriately classified as Class I (low-risk) under ANVISA’s regulations. This classification is for devices with minimal risk to patients and operators, such as simple surgical instruments or basic medical supplies.

2. Appoint a Brazilian Registration Holder (BRH)

• Foreign manufacturers must appoint a Brazilian Registration Holder (BRH) to represent their device before ANVISA. This local representative is responsible for managing the application process, compliance, and post-market obligations within Brazil.

3. Prepare the Technical Dossier

• A simplified technical dossier is required for Class I devices. This should include:
  • Device Description: Details about the device's intended use, components, materials, and specifications.
  • Instructions for Use and Labeling: Comprehensive usage instructions and labeling information, including warnings and precautions, in Portuguese. ANVISA requires labeling to be user-friendly and meet Brazilian standards for medical device labeling.
  • Product Photographs or Diagrams: Clear images or diagrams that show the device’s design, key components, and any relevant parts that affect safety and performance.

4. Quality Management System (QMS) Compliance

• While Class I devices may not need extensive quality documentation, they must still comply with quality standards. Proof of a QMS, such as an ISO 13485 certificate, may be required to demonstrate that the manufacturing and quality processes meet international quality standards.

5. Technical File and Safety Evidence

• The technical file for a Class I device should be thorough and include:
  • Compliance Statements: Affirmations that the device meets Brazilian regulatory standards for safety and performance.
  • Sterilization (if applicable): If the device is supplied sterile, provide documentation of the sterilization method, validation reports, and sterility assurance.
  • Product Testing (if applicable): Basic performance or safety testing, if relevant, should be documented, although this is generally less extensive for Class I devices.

6. Registration Fees

• Payment of the registration fee is required, and the amount varies based on device classification and company size. This fee covers ANVISA’s review process and is necessary for the registration application to proceed.

7. Electronic Submission

• Submit the completed application, including all required documents, through ANVISA’s electronic system. The Brazilian Registration Holder (BRH) will handle the submission, ensuring that all files are correctly uploaded and formatted.

8. Post-Market Surveillance and Maintenance

• After approval, maintain compliance with ANVISA’s post-market surveillance requirements. For Class I devices, this includes monitoring device performance, reporting adverse events, and ensuring that the device remains compliant with Brazilian standards throughout its five-year registration period.

9. Renewal Every Five Years

• ANVISA requires renewal of device registration every five years. The renewal process typically requires updated documentation and confirmation that the device still complies with all current regulations.

Key Considerations for Class I Device Registration

• Translation Requirements: All instructions, labels, and critical documents must be in Portuguese.
• Accurate Representation: The device must be accurately described and classified, with any misleading claims removed to avoid delays.
• Local Representation: The BRH must be familiar with ANVISA’s requirements and capable of handling all regulatory interactions.

Meeting these requirements carefully can help streamline the registration process and enable timely market access for Class I medical devices in Brazil.

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