Applying for Class III medical device registration with ANVISA (Brazil’s National Health Surveillance Agency) involves a complex process to ensure that the device meets Brazil's regulatory standards. Here are the general steps:

1. Appoint a Brazilian Registration Holder (BRH)

• Non-Brazilian companies must partner with a local Brazilian entity, known as a Brazilian Registration Holder (BRH). This entity will be legally responsible for the product in Brazil.

2. Technical Documentation Preparation

• Prepare the required technical documentation in Portuguese, which includes detailed information about the device, such as:
  • Device description and intended use
  • Risk management files and clinical data demonstrating safety and efficacy
  • Manufacturing process and quality management systems (aligned with ISO 13485 or equivalent)
  • Instructions for use and labeling

3. INMETRO Certification (if required)

• For devices requiring electrical safety and performance, an INMETRO certification from the National Institute of Metrology, Standardization, and Industrial Quality may be necessary. This certification is mandatory for specific classes of medical devices.

4. Good Manufacturing Practices (GMP) Certification

• Obtain ANVISA GMP certification by submitting a request for inspection of the manufacturing facility. ANVISA must conduct a facility inspection, which can take time depending on resource availability. This certification aligns with ANVISA's Resolution RDC 16/2013.

5. Product Dossier Submission to ANVISA

• Once you have all necessary certifications and documents, submit the product dossier to ANVISA. The dossier includes:
  • Technical documents
  • Clinical data (if applicable)
  • GMP and other required certificates
• Submit through ANVISA’s electronic system, known as "Solicita."

6. Application Review and Approval

• ANVISA reviews the application, potentially requesting additional information. This review can be lengthy, often lasting several months to over a year for Class III devices.
• Following a successful review, ANVISA will issue a registration approval valid for five years.

7. Post-Market Surveillance and Renewals

• Comply with post-market surveillance regulations, reporting adverse events or issues with the device. Renewal applications must be submitted before the expiration date to continue selling the product in Brazil.

Working with an experienced regulatory consultant and ensuring strict adherence to ANVISA’s requirements can be beneficial, especially for navigating the GMP inspection and dossier preparation phases.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn