Infarmed said, in a statement, that it was within the scope of an inspection, that it verified that type II surgical masks, brand Shiningjoy, from the manufacturer Shiningjoy, "do not meet the requirements for their placing on the market or putting into service” pursuant to the regulation of the European Parliament and of the Council, of 5 April 2017, on medical devices.
According to the National Authority for Medicines and Health Products, no formal evidence of compliance with all the general safety and performance requirements established in the aforementioned legislation was presented, including a clinical assessment.
It was also verified within the scope of the inspection that the technical documentation required for placing Shiningjoy surgical masks on the market was not complete.
On June 4, an online hearing was held between the company Shiningjoy and Infarmed, in which the drug authority had the opportunity to “explain in detail the non-conforming situation identified and inform the company of the likely intention to come to order the immediate suspension of the sale and collection of the aforementioned devices with improper CE marking”.
At the same hearing, the company had the opportunity to declare that it considered that it was in a position to review all the technical documentation in order to comply with the requirements set out in the legislation.
Shiningjoy was asked to submit "formal evidence" within 10 days that it complied with all the general safety and performance requirements required by law. On June 17, a new version of the technical documentation was sent to Infarmed, which, after evaluation by this authority, "has proved insufficient".
In another communiqué, also published today on its website, Infarmed also determines the suspension of the marketing and withdrawal from the market of the surgical mask type IIR brand Texpromed, with CE marking, from the manufacturer AMMA 1981 - Têxtil, SA, because “there is no compliance evidence with all legal requirements applicable at European level, including incomplete technical documentation” in relation to what is established in the EU Regulation.
It also appeals to entities that may have units of this medical device not to sell them and to contact the manufacturer.