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“Ukrainian Medical Centre of Certification” is a state enterprise founded in 2001 as state-owned property and belongs to the Ministry of Healthcare of Ukraine management sphere.

From the moment of foundation, the main line of work of the centre was execution of technical expert examination of medical devices during their registration/ reregistration, warranty and qualification tests (SE “UMCC” was listed as expert institution in compliance with its profile, involved by Ukrainian Medicines and Healthcare Products Regulatory Agency to run examinations and tests on medical devices for their official registration).

In 2010 ES “UMCC” was appointed by State Standard of Ukraine to work in state Certification system “UkrSERPO”

SE “UMCC” was assigned for conformity assessment of previous versions of medical devices to Technical regulations 2008. In 2012 it issued first Certificate of Conformity to Technical Regulations for medical device in Ukraine.

Experts from SE “UMCC” participated in development of current versions of Technical regulations for medicine.

Since 2005 SE “UMSCC” has been accredited as conformity assessment body for medical devices by National Accreditation Agency of Ukraine.

Since 2006 SE “UMSCC” has its own quality management system, which meets the requirements of ISO 9001 standard.

Since 2009 SE “UMSCC” has been accredited a Quality management systems certification body by National Accreditation Agency of Ukraine.

Since 2014 SE “UMSCC” has been accredited an authorized body for conformity assessment of medical devices to Technical regulations provided in 2013 (Technical regulations for medical devices; Technical regulations for active implantable medical devices; Technical regulations for IVD medical devices).

Since 2016 SE “UMSCC” has its own accredited testing laboratory.

SE “Ukrainian Medical Centre of Certification” has a long history of exemplary and stable work. Our principles have always been expert approach, competence, integrity and detachment.

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