The registration process for Class III medical devices with Brazil's ANVISA (Agência Nacional de Vigilância Sanitária) is a detailed and highly regulated procedure. Class III devices are considered high-risk and require comprehensive documentation and evidence to ensure their safety, efficacy, and quality. Below is an overview of the registration process, the materials needed, and the key points to note:

Registration Process for Class III Medical Devices with ANVISA

1. Appoint a Brazilian Registration Holder (BRH)

• Foreign Manufacturers: Must appoint a Brazilian Registration Holder (BRH), who will act as the local representative and be legally responsible for the device in Brazil. The BRH will manage communication with ANVISA throughout the registration process.
• Domestic Manufacturers: Can submit directly but must still meet all regulatory requirements and provide necessary documentation.

2. Prepare the Technical Dossier

The technical dossier is the primary document that supports your device’s registration and must include detailed technical information. This dossier must be submitted in Portuguese.

Key Materials for the Technical Dossier:

• Device Description and Intended Use: Detailed description of the device, its intended medical purpose, and the technological aspects.
• Clinical Evidence: This includes clinical trial data demonstrating the device’s safety and efficacy. ANVISA requires clinical evidence to support high-risk devices. If clinical trials are conducted outside Brazil, they must meet international standards such as Good Clinical Practices (GCP) and ISO 14155.
• Risk Management Report: A risk assessment report based on ISO 14971 that evaluates potential hazards and outlines the strategies to mitigate them.
• Quality Management System (QMS): Documentation proving compliance with ISO 13485 or an equivalent quality standard. This includes information on the manufacturing site’s processes, controls, and policies.
• Labeling and Instructions for Use: A copy of the device’s label and instructions for use in Portuguese, outlining key information, warnings, and usage guidelines.
• Manufacturing Information: Information about the manufacturer’s facility, including proof of compliance with Good Manufacturing Practices (GMP).

3. Obtain Good Manufacturing Practices (GMP) Certification

• GMP Certification is required for Class III devices, confirming that the device is manufactured under appropriate standards. This can involve on-site inspections of the manufacturing facility by ANVISA (for foreign manufacturers) or the submission of an already existing GMP certificate from an internationally recognized body.
• GMP certification must be obtained before submitting the registration dossier to ANVISA.

4. INMETRO Certification (if applicable)

• For devices that include electrical or electromagnetic components, INMETRO (National Institute of Metrology, Standardization, and Industrial Quality) certification is often required to ensure electrical safety.
• This step may involve laboratory testing by an INMETRO-accredited testing center.

5. Submit the Application

• Once all the documents are ready, the application is submitted through ANVISA’s electronic system called Solicita.
• This submission must be completed by the Brazilian Registration Holder if you are a foreign manufacturer.
• Along with the technical dossier, you will need to pay the ANVISA registration fee.

6. ANVISA Review

• ANVISA will evaluate the application and documentation. This process can take between 12-18 months for Class III devices due to the complexity and risk level of these products.
• During this time, ANVISA may request additional information, documentation, or clarifications.

7. Respond to ANVISA's Requests for Information

• ANVISA may request further documents or revisions to the application. Responding promptly and comprehensively to ANVISA’s inquiries is crucial to avoid delays.

8. Approval and Registration

• If ANVISA is satisfied with the application, it will grant registration approval for the device. The approval will typically be valid for five years.
• Once approved, you may begin marketing the device in Brazil.

9. Post-Market Surveillance

• After registration, the manufacturer must comply with ANVISA’s post-market surveillance requirements, including reporting adverse events, device performance, and safety concerns.
• Annual reports may be required to update ANVISA on the device's usage and any safety or performance data.

Key Materials Required for Class III Medical Device Registration

Here is a checklist of the required materials:

1. Technical Dossier:
   • Device Description
   • Clinical Data
   • Risk Management Report
   • Quality Management System documentation (ISO 13485 or equivalent)
   • Labeling and Instructions for Use (in Portuguese)
   • Manufacturing Information (including GMP certification)
2. INMETRO Certification (if applicable for electrical devices)
3. GMP Certification from ANVISA or a recognized certification body
4. Registration Application and Payment of Fees

Key Points to Note

1. GMP Certification is Essential: ANVISA mandates GMP certification for Class III devices. This is a critical step that must be completed before submission.
2. Translation to Portuguese: All documents submitted to ANVISA must be in Portuguese. This includes the technical dossier, clinical evidence, and labeling.
3. Clinical Data Requirements: High-risk devices like Class III require extensive clinical data to demonstrate safety and efficacy. ANVISA may request additional studies or trials.
4. ANVISA Review Timeline: The review process can be lengthy, typically taking 12-18 months. This may vary depending on the complexity of the device and any additional information requests from ANVISA.
5. Local Representation: Foreign manufacturers must engage a Brazilian Registration Holder (BRH), who will be the point of contact with ANVISA.
6. Post-Market Surveillance: After approval, you must adhere to post-market surveillance requirements, including reporting adverse events and any product safety issues.
7. Renewal: Device registration is valid for five years. After this period, you must apply for renewal to continue marketing the device in Brazil.

By following these steps and ensuring compliance with the regulatory requirements, you can successfully register a Class III medical device with Brazil's ANVISA.