The Class I medical device registration process with Brazil’s ANVISA is streamlined, as these devices are considered low-risk. The process involves submitting an application through the Notification Pathway (Cadastro) and does not require a full technical dossier, as higher-risk devices do. Below is a step-by-step guide on the process:

1. Verify Device Classification

• Determine Classification: Confirm that the device falls under Class I according to Brazil’s medical device classification system. Class I devices are considered low-risk and typically require minimal regulatory oversight.
• Reference Brazilian Regulation: Check ANVISA’s classification criteria and confirm that the device meets the Class I criteria under RDC 185/2001.

2. Appoint a Brazilian Registration Holder (BRH)

• Select a BRH: Foreign manufacturers must work with a Brazilian Registration Holder (BRH), as ANVISA requires that the application be submitted by a local entity.
• BRH Responsibilities: The BRH will submit and manage the registration, maintain compliance, and handle communications with ANVISA.
• Legal Agreement with BRH: Establish a legal agreement detailing the responsibilities and liabilities of the BRH. The BRH will also be responsible for post-market activities.

3. Prepare Required Documentation

• Basic Technical Documentation: While Class I devices require less documentation, ANVISA still expects the following:
  • Product Description: Including intended use, functions, and specifications.
  • Labeling Information: Labels, packaging, and Instructions for Use (IFU), all translated into Portuguese.
  • Manufacturer Information: Details about the manufacturing site and quality management system (e.g., ISO 13485 certification, if available).
  • Risk Management Documentation: Briefly document any risks associated with the device and mitigation measures, aligning with ISO 14971 guidelines.
• Quality Compliance Evidence: Provide basic evidence of a Quality Management System (QMS) in place, such as ISO 13485 certification. While Class I devices have lower scrutiny, evidence of QMS helps demonstrate quality and compliance.

4. Submit the Application through ANVISA’s Online System

• Cadastro Submission: Register and submit the application through ANVISA’s Cadastro (registration) pathway, using the ANVISA online system (SNGPC).
• Upload Required Documents: Submit the required technical documentation, BRH information, and any relevant quality compliance evidence.
• Application Fees: Pay the relevant fees associated with the registration process. Fees for Class I devices are generally lower than for higher-class devices.

5. Review and Approval by ANVISA

• ANVISA Review: ANVISA reviews the application for completeness and compliance with regulatory requirements. For Class I devices, this review is often faster and less stringent compared to higher-risk devices.
• Notification Pathway Confirmation: Once ANVISA completes the review and confirms that the device meets all Class I requirements, the registration is granted.
• Approval Notification: ANVISA issues a Cadastro Registration Number that allows the device to be marketed in Brazil.

6. Post-Registration Requirements

• Labeling Compliance: Ensure all labeling, including packaging and IFU, is in Portuguese and meets RDC 185/2001 requirements.
• Post-Market Surveillance (RDC 67/2009): Set up a system to handle complaints, adverse events, and corrective actions if needed. Report any adverse events to ANVISA.
• Maintain QMS Compliance: Maintain QMS and ensure compliance with any applicable regulations, such as RDC 16/2013 for Good Manufacturing Practices (GMP).
• Renew Registration Every Five Years: Class I registrations are valid for five years. Submit a renewal application to ANVISA before the registration expires.

Summary of Steps for Class I Medical Device Registration with ANVISA

1. Device Classification – Confirm Class I classification under RDC 185/2001.
2. BRH Appointment – Select and contract a Brazilian Registration Holder to manage registration.
3. Document Preparation – Gather required documentation, including product description, labeling, manufacturer details, and quality compliance evidence.
4. Cadastro Application Submission – Submit the application through ANVISA’s online system, including the required documents and application fees.
5. ANVISA Review – Await ANVISA’s review, which is generally shorter for Class I devices.
6. Post-Approval Compliance – Ensure post-market surveillance, maintain labeling compliance, and plan for five-year renewals.

Following these steps ensures a smooth registration process and helps maintain compliance with Brazilian regulations.

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