The processing time for Class I medical device registration with Brazil ANVISA is generally faster compared to higher-risk devices because Class I devices are considered low-risk and follow a simplified registration process. However, the exact timeline can vary depending on several factors, including the completeness of the application and the efficiency of the review process.

Typical Processing Time:

• Initial Review and Approval: For Class I devices, the processing time is typically around 30 to 60 days from the submission of the application to ANVISA. This timeline assumes that all documentation is complete and compliant with regulatory requirements.
• Simplified Pathway: Because Class I devices are subject to the Cadastro (notification) pathway, they do not require the detailed evaluations and inspections needed for higher-risk devices (Class II, III, or IV).

Factors That Can Affect Processing Time:

1. Completeness of Submission: If the submitted documents (such as product descriptions, labeling, and other required materials) are incomplete or unclear, ANVISA may request additional information or clarification, which can delay the approval process.
2. Volume of Applications: The volume of incoming applications to ANVISA can also influence processing times. During periods of high application volumes, there might be slight delays.
3. Brazilian Registration Holder (BRH): The efficiency of the Brazilian Registration Holder (BRH) in managing the submission and responding to any ANVISA requests for clarification can also impact the overall timeline.

Post-Approval:

Once ANVISA issues the approval, the device will be granted a Cadastro registration number, allowing the product to be marketed in Brazil. The registration is generally valid for five years, after which it must be renewed.

Summary of Typical Processing Time:

• 30 to 60 days for Class I device registration, assuming a complete and compliant application.
• Delays may occur if additional information is requested or if the application is not fully prepared.

This streamlined process reflects the low-risk nature of Class I devices, allowing for quicker approval compared to higher-risk device classes.

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