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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 undue CE marking, by “There is no evidence (proof) of compliance with all applicable legal requirements and the technical documentation is incomplete.”
At stake 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 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.
The covid-19 pandemic has already claimed at least 889,498 deaths and infected more than 27.1 million people in 196 countries and territories, according to a report by the French agency AFP.
In Portugal 1,843 people died of the 60,507 confirmed as infected, according to the latest bulletin from the Directorate General of Health.
