To register a Class I medical device with ANVISA (Brazilian Health Regulatory Agency), you must follow a structured process involving documentation submission, compliance with local regulations, and using ANVISA’s electronic platform for application. Here's a step-by-step guide on how to proceed:

Step-by-Step Process for Registering a Class I Medical Device with ANVISA

1. Confirm the Classification

Before starting the registration process, verify that your device qualifies as Class I according to ANVISA’s classification system. Class I devices are low-risk medical devices, and they have fewer regulatory requirements than higher-risk devices.

• Class I device criteria: Devices that are considered low-risk, non-invasive, and typically do not require clinical trials for registration.
• Refer to RDC 16/2013 and RDC 185/2001 for classification details.

2. Designate a Local Representative (if applicable)

If you are a foreign manufacturer, you must have a local representative in Brazil who will handle the regulatory process on your behalf. This could be an importer, distributor, or an authorized person in Brazil.

• The local representative is responsible for ensuring that the product complies with ANVISA regulations and for submitting the registration application.

3. Prepare the Required Documentation

Prepare all the necessary documentation to support your registration application. For Class I medical devices, the following documents are typically required:

• Application Form: Complete the ANVISA registration application form through their e-PL (Electronic Process) system.
• Product Description and Technical File: Provide details of the device including:
  • Device description and intended use.
  • Components and specifications.
  • Manufacturing process.
  • Risk management documentation (if applicable).
• Labeling: Include the product labeling in Portuguese, which must comply with ANVISA's requirements, including:
  • Manufacturer’s details.
  • Instructions for use (IFU).
  • Contraindications, indications, and warnings.
  • Batch/lot numbers and expiration dates, if applicable.
• Quality Management System (QMS): If applicable, provide evidence of compliance with a Quality Management System (e.g., ISO 13485) or Good Manufacturing Practices (GMP).
• Certificate of Free Sale: For imported devices, provide a Certificate of Free Sale from the country of origin.
• Authorization to Import: If the device is imported, the importer needs to provide a document authorizing the importation.

4. Submit the Application via ANVISA’s e-PL System

• Log in to ANVISA’s e-PL system to submit your application. This is the official platform for all regulatory submissions to ANVISA.
• Upload the completed application form and all required documents in the specified format.
• Ensure all documents are translated into Portuguese (especially the labeling and instructions for use).
• Pay the registration fee (the fee varies based on the device and classification).

5. Application Review by ANVISA

Once submitted, ANVISA will conduct a documentary review of the application. This includes:

• Ensuring that all necessary documentation is submitted.
• Checking compliance with Brazilian medical device regulations (RDC 16/2013, RDC 67/2009, and others).
• The review is based on documentation, and typically, Class I devices do not require testing or clinical trials for approval.

6. Additional Information or Clarifications (if needed)

If ANVISA identifies any discrepancies, missing documents, or requires further information, they will request clarifications. You must provide any additional materials promptly to avoid delays.

7. Approval and Issuance of Registration

If ANVISA finds the application complete and compliant, they will approve the registration and issue a Registration Certificate (Cadastro) for the product. The registration number must be included on the device’s labeling.

• The registration allows the device to be marketed and sold in Brazil.
• Class I devices are typically approved quickly, often within 1 to 3 months if all documents are complete and accurate.

8. Post-Market Requirements

After the device is registered:

• Post-market surveillance is required. Manufacturers and distributors must monitor the performance of the device in the market and report any adverse events or product defects to ANVISA.
• Amendments: If there are any changes to the device or its labeling, an amendment to the registration may be required.

Summary of the Registration Process

1. Confirm device classification (Class I).
2. Designate a local representative (for foreign manufacturers).
3. Prepare required documents:
   • Application form, technical documentation, labeling (in Portuguese), QMS/GMP proof, etc.
4. Submit the application through ANVISA’s e-PL system.
5. ANVISA review: Documentary check and approval.
6. Approval and Registration: Receive the registration certificate and number.
7. Market the device in Brazil and comply with post-market surveillance.

Additional Considerations

• Language: All documents submitted to ANVISA must be in Portuguese.
• Costs: The registration fee depends on the type of device but is generally lower for Class I devices compared to higher-risk classes.
• Importation: For imported devices, the importer must handle the customs clearance and distribution within Brazil.

By following these steps, you can successfully complete the Class I medical device registration process with ANVISA and gain approval to market your device in Brazil.

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