Class II medical device registration with ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil refers to the regulatory process required for medical devices that present moderate risks to patients and users. These devices typically require more comprehensive evidence of safety and effectiveness than Class I devices but less than Class III devices.

Overview of Class II Medical Devices

Class II devices in Brazil include a wide range of products such as:

• Surgical instruments

• Diagnostic devices (e.g., blood glucose monitors)

• 
  

• Catheters
• Devices that are used in therapeutic procedures

Regulatory Framework

The registration of Class II medical devices is governed by ANVISA's Resolution RDC No. 185/2001 and other relevant regulations. The aim is to ensure that devices are safe, effective, and of good quality before they can be marketed in Brazil.

Steps to Apply for Class II Medical Device Registration

1. Determine Classification:

   • Confirm that your device is classified as Class II based on the risk factors associated with its use.

2. Prepare Technical Documentation:

   • Compile a technical file that includes:
     • Device Description: Detailed information about the device, including design, intended use, and manufacturing processes.
     • Safety and Effectiveness Evidence: Clinical data or literature supporting the device's safety and performance.
     • Risk Analysis: Documentation of a risk management process according to ISO 14971.
     • Quality Management System (QMS): Evidence of compliance with ISO 13485 or other relevant standards.
     • Labeling Information: Drafts of labels and instructions for use, including translations into Portuguese.

3. Legal Representation:

   • If the applicant is a foreign company, they must appoint a Brazilian legal representative who will act as the point of contact with ANVISA.

4. Online Application Submission:

   • Submit the application through ANVISA’s electronic system (e-ANVISA). You will need to create an account if you don’t already have one.

5. Payment of Fees:

   • Pay the required registration fee. The amount will depend on the specific device and the application details.

6. ANVISA Review:

   • After submission, ANVISA will review the application. They may request additional information or clarifications during this process.

7. Receive Registration Approval:

   • If approved, you will receive a registration number, and your device will be officially listed in ANVISA’s registry.

8. Post-Market Surveillance:

   • After registration, comply with ongoing surveillance requirements, including reporting any adverse events and conducting periodic safety updates.

Additional Resources

• ANVISA Official Website: For more details and updates on the registration process, refer to ANVISA's official website.
• Guidance Documents: ANVISA publishes guidance documents for specific types of devices which can provide additional clarity on requirements.

Tips

• Stay Updated: Regulatory requirements may change, so regularly check ANVISA’s website for updates.
• Consult Experts: Consider hiring a regulatory affairs consultant with experience in ANVISA processes to assist you through the application.

This process is essential for ensuring that Class II medical devices are compliant with Brazilian regulations and are safe for public use. If you have any specific questions or need further assistance with a particular aspect of the registration process, feel free to ask!

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