No, Class III medical device registration with Brazil's ANVISA does not require annual renewal. However, it is important to note that medical device registrations in Brazil are valid for a period of 5 years from the date of approval.

Renewal Process:

• 5-Year Renewal: After the initial 5-year registration period, the manufacturer must apply for a renewal to continue marketing and selling the device in Brazil.
• Application for Renewal: The renewal process involves submitting updated documents, including any changes to the device, its labeling, or manufacturing processes, as well as confirming continued compliance with regulatory standards.
• Timing: The renewal application must be submitted at least 6 months before the registration expires to avoid any lapse in the device's market authorization.

Key Points:

1. No Annual Renewal: Unlike some other regulatory systems, ANVISA requires renewal only once every 5 years.
2. Periodic Reporting: Manufacturers must also comply with post-market surveillance obligations and adverse event reporting, though this is not part of the renewal process itself.
3. Updated Information: During renewal, any updates or changes in the device's design, intended use, clinical data, or manufacturing process must be submitted for ANVISA's review.

In summary, Class III medical device registrations with ANVISA are valid for 5 years, and renewal is required after that period, not annually.

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