FSUE "Moscow Endocrine Plant" took the 1st place in the All-Russian contest "Safety of medical devices for the benefit of people" (hereinafter - the Contest), established by the FSBI "National Institute of Quality" of Roszdravnadzor in the nomination "For the best knowledge of legislation in the field of circulation of medical devices".
The contest was held within the framework of the XXII annual All-Russian conference "State regulation in the field of circulation of medicines and medical devices" - "PharmMedObrashchenie 2020" in order to identify and support significant projects and best practices in the field of implementation of a quality management system in manufacture, as well as improving quality, efficiency and safety of medical devices approved for circulation on the territory of the Russian Federation.
A team of the Enterprise consisting of: Deputy General Director for Quality A.A. Ovchinnikova, Deputy Director for Quality of the Pochep branch N.N. Mansurova, Head of the Quality Department of the Lefortovsky branch A.A. Dzerzhinskaya, submitted the project “Improving the quality and efficiency of the production of disposable medical masks at the Pochep branch of the Moscow Endocrine Plant” to the Contest. The preparation of the Contest Project was also supported by the First Deputy General Director E.A. Yezhova, head of the medical department I.G. Kotelnikova, head of the validation department F.N. Semakin and the head of the quality control department of the Pochep branch D.P. Tuchapskaya. During the Contest, the team of the Enterprise successfully coped with all test questions and situational tasks related to the legislation in the field of circulation of medical devices.
In April 2020, the Federal State Unitary Enterprise “Moscow Endocrine Plant”, on behalf of the Ministry of Industry and Trade of Russia, launched a project to organize the production of disposable medical masks with a capacity of up to 4 million per day. In the process of implementing the project, the Enterprise was solving tasks to improve the efficiency of the organized production, by switching to a full cycle production using domestic raw materials, as well as confirming the compliance of the products with the highest quality standards.
As a result of the implementation of the tasks, in June 2020, the FSUE "Moscow Endocrine Plant" produced the first industrial batches of disposable medical masks corresponding to the IR type, and by September 2020, organized a full production cycle using domestic raw materials: from the manufacture of high-tech filter material – meltblown – to the manufacture of components – nose clips and elastic bands for ear loops. In October 2020, medical masks (with a filtering layer – meltblown) manufactured by the Federal State Unitary Enterprise "Moscow Endocrine Plant" were tested for compliance with the EN 14683 standard for the IIR type.
Currently, production is carried out in volumes corresponding to the needs of the domestic market. In order to realize the export potential, the procedure for issuing a CE declaration for disposable medical masks of IIR type was launched by the notifying body of the European Union.
Comment type is not specified in the component properties.