In Brazil, Class III medical devices are high-risk products regulated by ANVISA (Agência Nacional de Vigilância Sanitária), the Brazilian health regulatory agency. These devices often support or sustain human life, have significant potential health impacts, and thus are subject to stringent controls. Examples include implantable devices, certain diagnostic tests, and life-supporting equipment.

What Does Class III Medical Device Registration with ANVISA Involve?

Class III medical device registration is a process to obtain ANVISA's approval for marketing these high-risk devices in Brazil. The registration ensures that the device is safe, effective, and compliant with Brazil's health regulations.

Steps to Apply for Class III Medical Device Registration with ANVISA

1. Engage a Brazilian Registration Holder (BRH)

• For foreign manufacturers, appointing a Brazilian-based legal representative (BRH) is required. This entity manages communication with ANVISA and assumes responsibility for the product's compliance in Brazil.

2. Prepare Technical Documentation

• Create a comprehensive technical dossier in Portuguese. Key documentation includes:
  • Device Description and its intended use.
  • Risk Management documents showing assessment and mitigation of risks.
  • Clinical Data for demonstrating safety and performance, which may include clinical trial results or equivalent data from international markets.
  • Quality Management System information (compliance with ISO 13485 or an equivalent system).
  • Labeling and Instructions for Use in Portuguese.

3. Secure INMETRO Certification (if required)

• For electronic devices, the National Institute of Metrology, Standardization, and Industrial Quality (INMETRO) certification may be necessary to verify electrical safety and performance standards.

4. Obtain ANVISA’s Good Manufacturing Practices (GMP) Certification

• Submit a GMP certification request for ANVISA inspection of the manufacturing site. This step is crucial, as ANVISA mandates GMP compliance for higher-risk devices like Class III. If your manufacturing site already follows international standards, ANVISA may still require an on-site inspection.

5. Submit the Product Dossier to ANVISA

• Submit the dossier through ANVISA’s "Solicita" portal. Include all technical documents, clinical data, and necessary certificates.
• Once submitted, ANVISA will begin the evaluation, which may involve requesting additional information.

6. Respond to ANVISA Queries

• ANVISA may request additional documents or clarifications, which your BRH must address promptly. The review process can be extensive, often taking 12-18 months for Class III devices.

7. Receive ANVISA Approval

• Upon successful review, ANVISA grants a registration approval, valid for five years. After this, you must apply for renewal to continue marketing the device in Brazil.

8. Post-Market Surveillance and Compliance

• Maintain records and comply with ANVISA’s post-market surveillance requirements. Report adverse events, monitor product performance, and follow applicable regulations to ensure ongoing compliance.

Key Points to Note

• Timeline: Registration can take over a year, especially if a GMP inspection is involved.
• Renewals: Registration is valid for five years, with renewals required before expiration.
• Local Expertise: Working with an experienced regulatory consultant can help manage Brazil’s complex regulatory requirements and assist with language, legal, and procedural specifics.

A thorough and well-prepared submission, along with a reliable local representative, can greatly facilitate the ANVISA registration process.

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