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The National Medicines Authority (Infarmed) has 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 placing on the national market and commercialization of OrbitPlatform type I surgical masks, with inadequate CE marking, was identified because” there is no evidence (proof) of compliance with all the applicable legal requirements and 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 drug authority, “the manufacturer has 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, demonstrating compliance with the 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 balance made by the French agency AFP.
In Portugal 1,843 people died of the 60,507 confirmed as infected, according to the most recent bulletin of the General Directorate of Health.
