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The National Medicines Authority (Infarmed) ordered the immediate withdrawal from the market of surgical masks from the manufacturer OrbitPlatform for not complying with all legal requirements.
Infarmed announced, in a statement published on its website, that “the placement in the national market and the commercialization of type I surgical masks was identified” by OrbitPlatform, with improper CE marking, as “there is no evidence (proof) of compliance with all legal requirements applicable and the technical documentation is incomplete ”.
These are “type I surgical masks with references MC10001, MC10001.1, MC10002, MC10003 and type IIR with references MC20001, MC20002 and MC20003” from OrbitPlatform, a Portuguese company dedicated to the manufacture of surgical masks for protection against Covid-19.
Infarmed determined “the immediate withdrawal of said devices from the national market.”
According to the authority of medicine, “the manufacturer has voluntarily initiated the necessary mechanisms for the and suspension of the placing on the market of said sanitary products ”.
At the same time, it began the simplified process of marketing these devices in the national market in the terms of article 4 of Decree Law no. 14-E / 2020, of April 13, in its current wording, showing compliance with the regulatory and regulatory requirements. Published specifications, Infarmed said in the statement.
