The time it takes to obtain Class I medical device registration with ANVISA in Brazil can vary, but typically it takes between 1 to 3 months from the submission of the application to approval. The specific timeline depends on several factors, such as the completeness of the documentation submitted and whether ANVISA requests additional information.

Key Phases of the Process and Estimated Timelines:

1. Application Submission (1-2 weeks):

   • The process starts when you submit the complete application and required documentation via ANVISA’s e-PL (Electronic Process) system. The documentation must be in Portuguese, and it should include all required forms, product descriptions, labeling, and quality system certifications.

2. ANVISA Review (4-8 weeks):

   • ANVISA will review the submitted documentation to ensure compliance with Brazilian regulations. This includes checking the technical file, labeling, and other supporting documents. For Class I devices, which are considered low-risk, this phase is typically quicker.

3. Request for Additional Information (if applicable) (1-2 weeks):

   • If ANVISA identifies any discrepancies or missing information, they may request clarifications or additional documents. This can add some time to the process depending on how quickly you respond.

4. Approval and Registration Certificate Issuance (1-2 weeks):

   • Once ANVISA is satisfied with the documentation and there are no issues, the device will be approved, and a Registration Certificate (Cadastro) will be issued. This officially allows the device to be marketed and sold in Brazil.

Factors that Can Affect the Timeline:

• Completeness of Documentation: If the application is complete and all required documents are submitted without issues, the process will be faster. Incomplete or incorrect applications can lead to delays.
• Response Time: If ANVISA requests additional information or documentation, the timeline will depend on how quickly you provide the requested materials.
• ANVISA's Workload: The overall workload at ANVISA may also affect the timeline. If there are a large number of applications, processing times may increase.

Typical Timeline for Class I Devices:

• Fast Track: If everything is in order and there are no complications, Class I devices can be registered within 1 to 2 months.
• Average Case: On average, it takes around 2 to 3 months to complete the registration process.

In conclusion, the typical time for Class I medical device registration with ANVISA is around 1 to 3 months, but the actual time may vary based on documentation completeness and any follow-up requests from ANVISA.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn