No, Class I medical device registration with Brazil ANVISA does not require an annual review. However, there are some key points regarding maintenance and periodic obligations:

1. Validity Period

• Class I device registration is generally valid for five years from the date of approval by ANVISA.
• After this period, the registration must be renewed in order to maintain legal market access.

2. No Annual Review Requirement

• There is no annual review or routine submission required during the validity period for Class I devices.
• However, the Brazilian Registration Holder (BRH) must ensure ongoing compliance with ANVISA regulations, including proper labeling, post-market surveillance, and vigilance reporting if any issues arise with the device.

3. Post-Market Surveillance Obligations

• Post-market surveillance is still required. The manufacturer or BRH must monitor the device's performance in the market and report any adverse events or safety concerns to ANVISA.
• If significant issues arise or changes are made to the device (e.g., design modifications, new indications for use), an update to the registration may be necessary.

4. Annual Fees

• While annual reviews are not required, there may be annual fees or other periodic costs that need to be managed to maintain the registration, though this varies depending on the device and the registration holder.

5. Changes to the Device

• If there are any changes to the device’s specifications, manufacturing process, or intended use, the BRH must inform ANVISA and may need to submit a modification request, which could involve a review by ANVISA.

Summary:

• No annual review is required for Class I medical device registration with Brazil ANVISA.
• The registration is valid for five years, and renewal is required after that period.
• Post-market surveillance and reporting of any adverse events or device changes are ongoing obligations.