The 1st All-Russian Forum with international participation “Circulation of Medical Devices “NOVAMED-2021”, jointly organized by the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation, and the Federal Service for Surveillance in Healthcare, was held in Russia.
The forum was held in a hybrid format, bringing together leading domestic and foreign experts in the field of medical devices circulation.
The NOVAMED-2021 sessions covered a wide range of topical issues of state policy in the field of production of medical devices, reform of state control over the circulation of medical devices in the Russian Federation, registration of medical devices within the EAEU, digitalization in healthcare, activities of testing laboratories (centres), and post-registration supervision.
Endopharm acted as a partner of NOVAMED-2021, providing the forum participants with medical masks and Dezenda sanitizers of its own production.
In 2020 by the Order of the Government of the Russian Federation and on behalf of the Ministry of Industry and Trade of the Russian Federation, Endopharm, organized the production of medical masks in the Pochep branch in the Bryansk region, with a capacity of up to 4 million items per day. The organization of production made it possible to provide citizens and medical institutions of the country with the necessary amount of personal respiratory protection equipment and contributed to increasing their affordability.
During the implementation of the project, the Enterprise solved different tasks to improve production efficiency: by switching to a full cycle production using domestic raw materials, as well as confirming the compliance of released products with the highest quality standards.
In October 2020, Endopharm received a certificate of origin of goods ST-1 (medical masks) from the Union of the Moscow Chamber of Commerce and Industry, on the basis of which the localization of production in the Russian Federation was confirmed (conclusion of the Ministry of Industry and Trade of the Russian Federation on confirmation of the production of industrial products on the territory of the Russian Federation dated November 6, 2020).
In order to realize the export potential, in November 2020, a CE declaration was received for medical disposable masks, type IIR, which confirms the compliance of the products with the requirements of EU directives.
The production capacities of Endopharm allow the production of up to 2 million sterile medical masks - for use in operating rooms and other medical facilities with aseptic conditions.
The Endopharm project to organize the production of sterile medical masks in the Pochep branch won the 2nd place in the competition “Safety of medical devices for the benefit of people”, established by the Federal State Budgetary Institution “National Institute for Quality” of the Federal Service for Surveillance in Healthcare, within the framework of the NOVAMED-2021 forum.
In order to carry out operational quality control of the high-tech meltblown filter material and medical masks, Endopharm has organized its own testing laboratory.
Endopharm was represented at the round table “Activity of testing laboratories (centers): problems and prospects” by Anastasia Ovchinnikova, Deputy Quality Director, who presented the report “The experience of creating an accredited testing laboratory based on production to confirm the quality of products.”
The testing laboratory “Endopharm” organizes activities in accordance with the requirements of GOST ISO/IEC 17025-2019 “General requirements for the competence of testing and calibration laboratories.” Laboratory equipment, including testers for determining the bacterial filtration efficiency (BFE), checking differential pressure, particle filtration efficiency (PFE), testers of medical masks for resistance to artificial blood splashes, air permeability, water repellency testers, allows Endopharm to carry out a full range of testing of medical masks, respirators, disposable clothing and other products made of non-woven materials such as spunbond and SMS in accordance with international standards.
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