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Date: 10/08/2021

The deadline for uploading the medical devices’ instructions for use on ANVISA’s portal ends at the end of this month.

Resolution RDC No. 431/2020, which came into force on November 1st 2020, granted a period of 1 year to make registered devices’ instructions for use available, for products which were approved by ANVISA before the rule came into force. For new registrations or product alterations approved after the Resolution, the deadline to upload instructions for use is up to 30 days after the approval.

Uploading the instructions for use is a responsibility of the Registration Holder, and the information must be aligned with the sanitary legislation and exactly according to the registration approved.

ANVISA provided a Guide for companies to upload the instructions for use.

The full text of Resolution RDC No. 431/2020 can be accessed here.

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