Applying for Class II medical device registration with ANVISA (Agência Nacional de Vigilância Sanitária) in Brazil involves several processes that ensure the device meets safety and efficacy standards. Here’s a detailed breakdown of the processes involved:

1. Device Classification

• Determine Classification: The first step is to verify that the medical device is classified as Class II according to ANVISA's classification criteria, which are based on the intended use and associated risks. Class II devices typically require a higher level of regulatory control than Class I devices but less than Class III devices.

2. Preparation of Documentation

• Compile Technical File: Prepare a comprehensive technical file that includes:
  • Device Description: Detailed specifications, intended use, and design features.
  • Manufacturing Process: Overview of the manufacturing process, quality control measures, and information about suppliers.
  • Clinical Evaluation: Evidence of safety and efficacy, which may include clinical data or literature reviews.
  • Quality Management System Documentation: Proof of compliance with ISO 13485 standards, including policies, procedures, and records.
  • Risk Management Documentation: Risk assessment and management following ISO 14971 standards.
  • Labeling: Drafts of the device’s labels and instructions for use in Portuguese, ensuring compliance with ANVISA labeling regulations.

3. Appointing a Legal Representative

• Legal Representation: If the manufacturer is based outside Brazil, appoint a legal representative in Brazil who will act as the point of contact with ANVISA and manage regulatory compliance.

4. Application Submission

• Electronic Submission: Access ANVISA’s online system (Sistema de Peticionamento Eletrônico - SPE) to submit the application electronically. The submission involves:
  • Creating an account if you don’t have one.
  • Completing the required application forms.
  • Uploading all necessary documentation.
  • Paying the registration fee, as per ANVISA’s fee structure.

5. ANVISA Review Process

• Initial Review: ANVISA conducts an initial review of the submitted application to check for completeness, typically within 1-10 days.
• Technical Evaluation: The technical team evaluates the application in detail. This phase can take up to 60 days and involves assessing the safety, efficacy, and compliance with relevant standards.
• Requests for Additional Information: During the technical evaluation, ANVISA may request further information or clarification on specific aspects of the application.
• Final Decision: After completing the technical evaluation, ANVISA will issue a decision on the application, which may take an additional 20 days.

6. Post-Approval Activities

• Issuance of Registration Certificate: If the application is approved, ANVISA will issue a registration certificate that allows the manufacturer to market the device in Brazil.
• Post-Market Surveillance: Once the device is on the market, the manufacturer must implement a post-market surveillance system to monitor the device's safety and effectiveness.
• Ongoing Compliance: Maintain compliance with ISO 13485 and ANVISA regulations, including regular internal audits and updates to quality management documentation.

7. Renewal of Registration

• Monitor Registration Validity: Class II medical device registrations are typically valid for five years. Manufacturers should monitor the expiration date and initiate the renewal process at least 60 days before expiry.

Summary of Processes

1. Device Classification: Verify the Class II status.
2. Preparation of Documentation: Compile the technical file, risk management documents, and quality management records.
3. Legal Representation: Appoint a legal representative in Brazil if necessary.
4. Application Submission: Submit the application electronically via ANVISA’s online system and pay the fee.
5. ANVISA Review Process: Undergo initial review, technical evaluation, and respond to any additional requests.
6. Post-Approval Activities: Receive the registration certificate and implement post-market surveillance.
7. Renewal Monitoring: Prepare for renewal of registration as needed.

Conclusion

By following these processes, manufacturers can effectively navigate the application for Class II medical device registration with ANVISA. Ensuring thorough preparation and compliance with regulatory requirements is essential for a successful registration process. If you have any further questions or need assistance with specific aspects, feel free to ask!

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