[ad_1]
Infarmed announced, in a statement published in its website, this Monday, that “the placement in the national market and the commercialization of type I surgical masks was identified” by OrbitPlatform, with undue CE marking, because “there is no evidence of compliance with all applicable legal requirements and technical documentation if finding incomplete ”.
These are the “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 drug authority, “the manufacturer voluntarily initiated the necessary mechanisms for the collection and suspension of the marketing of said medical devices.”
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.
