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Infarmed has suspended the marketing of surgical masks from the manufacturer LINEFORYOU for improper use of the CE marking, revealed the National Authority for Medicines and Health Products. The technique is incomplete compared to what the law requires.
“The manufacturer immediately and voluntarily initiated the suspension of the commercialization of the medical devices under consideration and will initiate the simplified process of commercialization” of these devices in the terms of the law, “demonstrating compliance with the published regulatory requirements and specifications” . According to data released earlier this month, since the start of the pandemic, the Food and Economic Safety Authority (ASAE) has already seized more than a million masks as part of the various inspection actions that are carried out throughout the country. According to the ASAE, a total of 1,123,093 masks have been seized since mid-March.
The main infractions detected were the breach of the duties of distributor and importer, the lack of translation into Portuguese of instructions and safety information, the incorrect affixing of the CE marking and on products that do not comply with the EU harmonization legislation and the violation of the rules for the affixing of the CE marking on personal protective equipment, among others.
