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ANVISA Updates Importation Law: Key Changes

  1. The amended resolution now authorizes the importation of medical equipment and their accessories if the date of manufacture precedes the date of notice or registration. The caveat is that the time between the device’s manufacturing date and the registration date cannot exceed five years, and such items must closely adhere to the ANVISA approval standards.
  2. A statement from the holder of the notice or registration attesting to conformity with both requirements is required for the import of medical equipment under the terms of the first point.
  3. The Medical Device that is to be imported in accordance with the provisions of the first point must, as appropriate, be within its expiration date and in compliance with applicable laws.

Brazil’s Import Manual, Manual de Importaço de Dispositivo Médico (link in Portuguese), was also modified to reflect this modification and to include discussions on the data for regularization of customized medical equipment and devices involving ruminant animal tissues or fluids.