The timeline for Class I medical device registration with Brazil’s ANVISA is generally shorter and more straightforward compared to higher-risk devices. Since Class I devices are low-risk, the application process follows a Cadastro (notification) pathway, designed to be less complex. Here’s an overview of the timeline and review stages:

Estimated Timeline for Class I Registration

• Preparation of Documents: 2-4 weeks
  • This involves gathering necessary documents, such as product descriptions, labeling, and evidence of quality management compliance. It also includes coordination with a Brazilian Registration Holder (BRH) and translation of documents into Portuguese.
• Submission to ANVISA: Immediate (Once documents are ready)
  • The BRH submits the completed application through ANVISA’s online system (SNGPC). This step is quick, as it involves uploading documentation and paying the application fee.
• ANVISA Review and Approval: Approximately 4-6 weeks
  • ANVISA performs a review to ensure compliance with the applicable regulations for Class I devices. Since this is a low-risk device classification, the review is usually streamlined, with fewer scrutiny levels than Class II, III, or IV devices.

Key Review Stages in the Class I Registration Process

1. Pre-Submission Stage

   • Document Preparation: Gather and verify all required documentation to ensure compliance with ANVISA’s requirements. Coordination with the BRH is essential for submission and ensuring document accuracy.

2. Application Submission Stage

   • Online Application Submission: The BRH submits the device registration application on ANVISA’s system, uploading all required documents. This submission process includes payment of registration fees.
   • Initial Completeness Check: ANVISA will verify if all required documents are present and complete. Missing or incomplete documents could delay the review.

3. ANVISA Review Stage

   • Document Review and Verification: ANVISA reviews the application primarily to ensure that all requirements for Class I devices are met. Since Class I devices are low-risk, ANVISA does not typically require a full technical dossier.
   • Quality Compliance Verification: ANVISA may perform a basic check of the manufacturer’s quality management system. For Class I devices, ISO 13485 certification is recommended but not always mandatory.

4. Approval and Notification Stage

   • Issuance of Cadastro Registration Number: If the application is approved, ANVISA issues a Cadastro (notification) registration number, which authorizes the device for sale in Brazil.
   • BRH Notification: The BRH receives the notification and manages any post-approval steps, including ensuring proper labeling and post-market surveillance.

5. Post-Approval Obligations

   • Compliance with Post-Market Requirements: After approval, the device must comply with post-market surveillance (e.g., adverse event reporting) and labeling standards.
   • Five-Year Renewal Requirement: Class I registrations are valid for five years, after which a renewal application should be submitted.

Total Timeline Overview

The entire process typically takes around 2-3 months from the initial preparation to the final registration approval by ANVISA.

Considerations for Delays

• Incomplete Documentation: Missing or improperly prepared documents can cause delays. Working closely with a BRH helps ensure all required information is provided upfront.
• ANVISA Backlog: While the review for Class I devices is generally quicker, ANVISA workload and backlog could impact timelines.
• Complexity of Changes: If changes are made to the application post-submission, additional review time might be needed.

By ensuring all documents are in order and coordinating with the BRH, the process can be completed efficiently within the expected timeline.

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