Class III medical device registration with Brazil's ANVISA (Agência Nacional de Vigilância Sanitária) is a detailed process designed to ensure that high-risk medical devices meet safety, efficacy, and quality standards. Here’s an overview of the procedures and steps involved:

1. Appoint a Brazilian Registration Holder (BRH)

• Non-Brazilian companies are required to designate a local entity, known as a Brazilian Registration Holder (BRH), who will be legally responsible for the device within Brazil. The BRH acts as the official liaison with ANVISA.

2. Preparation of Technical Documentation

• Gather a comprehensive technical dossier in Portuguese, which must include:
  • Device Description: Detailed information on the device’s intended use, components, and functionality.
  • Clinical Evidence: Clinical trials or studies demonstrating the device’s safety and efficacy. ANVISA may accept clinical data from international studies if they meet Brazilian standards.
  • Risk Management Report: Based on ISO 14971, showing all identified risks and the methods used to control them.
  • Quality Management System (QMS): Information showing compliance with standards such as ISO 13485.
  • Instructions for Use and Labeling: Product labeling, user instructions, and indications, all in Portuguese.

3. INMETRO Certification (if applicable)

• If the device involves electrical or electromagnetic components, it may need certification from INMETRO (National Institute of Metrology, Standardization, and Industrial Quality) to verify safety and performance in Brazil.

4. Obtain ANVISA Good Manufacturing Practice (GMP) Certification

• Class III devices require ANVISA’s GMP certification, which confirms compliance with Brazil’s manufacturing standards (similar to ISO 13485). To obtain this:
  • Submit a GMP Application: Request a GMP inspection from ANVISA for the manufacturing facility. Foreign facilities will need to undergo an inspection by ANVISA auditors unless they already have an acceptable certification under a recognized mutual agreement.
  • Pass the Inspection: ANVISA inspectors assess quality management, manufacturing processes, and other compliance areas.

5. Submit Product Dossier to ANVISA

• Once the technical documentation and GMP certification are ready, submit the product dossier through ANVISA’s electronic portal, Solicita. The submission includes:
  • Full technical documentation
  • Copies of GMP and other certificates
  • Clinical data and risk management documentation
• ANVISA will review the dossier and may request additional documentation or clarifications.

6. Respond to ANVISA's Additional Requests

• ANVISA often requests supplementary information during the evaluation process, which must be provided promptly to avoid delays.

7. Await ANVISA's Decision

• The review process for Class III devices can take 12-18 months. ANVISA will either approve, deny, or request further changes to the application.

8. Receive Registration Approval

• Upon approval, ANVISA issues a registration valid for five years, allowing the product to be marketed and sold in Brazil.

9. Post-Market Surveillance Compliance

• Comply with ANVISA’s post-market surveillance regulations, including reporting adverse events, device failures, and any issues related to safety or performance.

10. Renew Registration

• The registration is valid for five years, after which it must be renewed. Renewal requires a review of the product’s compliance, any updates in regulatory requirements, and recent post-market data.

Additional Tips

• Local Expertise: Consulting a regulatory expert with ANVISA experience is recommended, as they can help navigate complex requirements.
• Documentation Quality: Ensuring that the submission documents meet ANVISA’s standards is essential for avoiding delays.

Class III device registration with ANVISA is detailed and time-intensive, but following each step carefully increases the likelihood of a successful application.

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