Daniel Torres Gonçalves
Joana Aguiar Rodrigues
Marina Bessa Sousa
October 13, 2023
Suspension of the marketing of tooth whiteners improperly qualified as medical devices
The Board of Directors of INFARMED – National Authority for Medicines and Health Products, I. P. (hereinafter INFARMED), through updating the information circular dated June 16, 2023, immediately suspended the marketing of the following tooth whiteners: Opalescende Endo, Opalescende Boost 40%, BMS White 38%, fläsh Chairside Light Whitening 32%, Norblanc Office, Norblanc Office Automix, Polaoffice+, Pola Day CP, Voco Perfect Bleach Office+, Pure Office.
The suspension is not due to a risk in the use of these products, but rather to an undue classification of them, namely because they are categorized as medical devices. The law defines a medical device as any instrument, apparatus, software or article, whose intended effect is not achieved by pharmacological means, intended to be used on human beings for the purposes of diagnosing, preventing and/or treating a pathology.
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