The typical time to obtain Class I medical device registration with Brazil ANVISA is relatively short compared to higher-risk devices, due to the simplified registration process for low-risk devices.

Processing Time for Class I Medical Device Registration:

• Approximately 30 to 60 days: This is the standard timeline for the review and approval of Class I medical device registrations by ANVISA, assuming that the application is complete and meets all regulatory requirements.

Factors Affecting Processing Time:

1. Completeness of the Application: If the documentation submitted is clear, complete, and fully compliant with ANVISA's requirements, the approval process is quicker. However, any missing or unclear information may result in delays as ANVISA requests additional documents or clarifications.
2. Application Volume: The processing time can be affected by the overall volume of applications ANVISA is handling at the time. If there is a high number of submissions, processing might take slightly longer.
3. Brazilian Registration Holder (BRH) Involvement: The efficiency of the Brazilian Registration Holder (BRH) in managing the submission and communication with ANVISA can also influence how quickly the process proceeds.

Summary:

• Typical time frame: 30 to 60 days for Class I device registration with ANVISA.
• Faster process: Class I devices benefit from a more streamlined and faster regulatory pathway compared to higher-risk devices.

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