The process for Class I medical device registration with ANVISA (Brazilian Health Regulatory Agency) involves several important steps. Class I medical devices are considered low-risk products, so the registration process is relatively straightforward, but it still requires careful attention to detail. Below are the steps involved in the registration process:

1. Preliminary Steps

A. Verify Classification

• Class I devices are low-risk and have minimal regulatory requirements compared to higher-risk classes (Class II and Class III).
• Before starting the registration, confirm that your device falls under Class I by reviewing ANVISA’s classification criteria outlined in RDC 16/2013 and RDC 185/2001.

B. Assign a Local Representative

• If you are a foreign manufacturer, you are required to designate a legal representative based in Brazil (importer or distributor). The local representative is responsible for managing the regulatory process with ANVISA, including handling documentation, communication, and compliance requirements.
• This representative must have the necessary authorization to submit registration applications on behalf of the manufacturer.

C. Check Device Compliance

Ensure that the device complies with applicable Brazilian regulations:

• RDC 16/2013 for classification.
• RDC 67/2009 for labeling requirements.
• RDC 56/2001 for good manufacturing practices, especially for manufacturers based in Brazil.

2. Prepare Documentation for Registration

A. Required Documentation for Class I Registration

The following documents are typically required for the registration of Class I medical devices with ANVISA:

1. Application Form: Complete the ANVISA registration application form via e-PL (Electronic Process of ANVISA).
2. Product Technical File: Provide detailed technical documentation about the product, including:
   • Description of the device (including its intended use, technical specifications, and key components).
   • Design and manufacturing process.
   • Risk management documentation, if applicable.
   • Clinical evidence (if needed, although less common for Class I devices).
3. Labeling: Submit the product’s labeling (in Portuguese) as required by RDC 67/2009. This includes:
   • Manufacturer details.
   • Instructions for use (IFU).
   • Warnings, contraindications, and indications.
   • Batch/lot number, expiration date (if applicable).
4. Quality Management System (QMS): If applicable, provide proof of a Quality Management System (e.g., ISO 13485 certification). This may be necessary if the device involves complex manufacturing processes.
5. Good Manufacturing Practices (GMP): Proof of GMP compliance if the device is manufactured within Brazil or imported from abroad.
6. Authorization for Import: For imported devices, the importer must provide authorization to import the device.
7. Certificate of Free Sale: If the device is imported, a Certificate of Free Sale from the country of origin may be required.

B. Translate Documents into Portuguese

All documents, including labels, instructions for use (IFU), and technical documentation, must be translated into Portuguese, as ANVISA requires all registration materials to be in the national language.

3. Submit Application to ANVISA

A. Use the e-PL System

• ANVISA’s e-PL system is the official platform for submitting medical device registration applications.
• The application must be submitted online with all required documents attached. A digital signature is required for submission.
• Fee Payment: Pay the registration fee, which depends on the type of device and its risk classification. Fees for Class I devices are generally lower than for higher-risk categories.

B. Application Review by ANVISA

• Once the application is submitted, ANVISA will conduct an initial review to ensure that all required documents are included and that the device complies with applicable regulations.
• For Class I devices, ANVISA typically conducts a documentary review rather than requiring detailed technical assessments.
• ANVISA may request additional information or clarification during this stage.

4. Post-Submission Review and Approval

A. Approval or Additional Requests

• If ANVISA finds everything in order, it will approve the registration and issue a registration number for the product.
• If ANVISA identifies any issues or missing information, it will request clarifications or further documentation. Responding promptly to any ANVISA requests can help avoid delays.

B. Issuance of Certificate

• After approval, ANVISA will issue a Certificate of Registration for the device. This certificate is required for the device to be sold and marketed in Brazil.
• The registration number and certificate must be included on the device labeling.

5. Market Authorization and Distribution

• Once registered, the Class I device can be marketed and distributed within Brazil.
• For imported devices, the importer is responsible for ensuring the product is delivered to Brazil in compliance with ANVISA regulations.
• The importer must submit the necessary documentation (such as registration number and Certificate of Free Sale) to customs for clearance.

6. Post-Market Surveillance and Compliance

A. Reporting and Vigilance

• Even after registration, post-market surveillance is required. Manufacturers and distributors must:
  • Monitor the performance of the device on the market.
  • Report any adverse events or product defects to ANVISA as required by RDC 55/2010.
  • Implement necessary corrective actions if safety or performance issues are identified.

B. Maintenance of Registration

• Regular updates to the registration may be required if there are changes in the device (e.g., new versions, changes in manufacturing, or labeling modifications).
• Periodic renewals may not be required for Class I devices, but if significant changes occur, an amendment to the registration must be submitted.

Summary of Steps for Class I Medical Device Registration with ANVISA:

1. Verify classification to ensure the device qualifies as Class I.
2. Prepare required documentation, including the technical file, labeling, GMP proof, and QMS if applicable.
3. Submit the application via ANVISA's e-PL system.
4. ANVISA review of submitted documentation for completeness and compliance.
5. Receive approval and a registration certificate from ANVISA if everything is in order.
6. Market the device and ensure ongoing post-market surveillance.

By following these steps, you can successfully complete the Class I medical device registration process with ANVISA in Brazil.

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