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The Ukrainian Certification Agency (cascaded name – UCA) originates in 2011. Leading specialists of the enterprise have been engaged in examination of registration / technical documentation for more than ten years, the results up to clinical and clinical studies of medical products, medicines and other products and conditions of their production, have experience in technical regulation, in particular product certification and management systems.
In 2016, the National Agency for Accreditation of Ukraine attested the competence of the UCA in accordance with the requirements:
– ISO / IEC 17065: 2012 in the field of: medical products, active medical products that are implanted, medical products for in vitro diagnostics (Certificate of Accreditation No. 1О310 of July 15, 2016);
– ISO / IEC 17021-1: 2015 in the field of: DSTU ISO 9001: 2015 “Quality management systems. Requirements “; ISO 9001: 2015 “Quality management systems – Requirements”; DSTU EN ISO 13485: 2015 “Medical devices. Quality management system. Requirements for regulation “; ISO 13485: 2003 / Cor 1: 2009 “Medical devices – Quality management systems – Requirements for regulatory purposes”; EN ISO 13485: 2012 “Medical devices – Quality management systems – Requirements for regulatory purposes” (The certificate of accreditation of July 20, 2016 No. 8О110).
In accordance with the Order of the Ministry of Economic Development and Trade of Ukraine No. 265 of February 24, 2017, the UCA was appointed as the conformity assessment body to assess compliance with the requirements of the Technical Regulations on Medical Devices approved by Resolution No. 753 of the Cabinet of Ministers of Ukraine on 02.10.2013 and assigned an identification number UA.TR.121.
In 2016, UCA established its own testing laboratory, the competence of which was attested by the National Agency for Accreditation of Ukraine in accordance with the requirements of DSTU ISO / IEC 17025: 2005 (Certificate of Accreditation No. 2Н1445 dated November 18, 2016).
The main activity of the enterprise is the work on conformity assessment, in particular certification of medical products and other products, and certification of management systems, including the organization of cooperation with the bodies for assessing the conformity of other states, recognizing the results of their job.
By choosing the Ukrainian Certification Agency as a conformity assessment body, you receive a reliable and responsible partner and obtain the support of a team of professionals in conformity assessment of products / quality management systems.
We guarantee the compliance of the confidentiality regime regarding any information received from our partners.
Impartiality policy of "UKRAINIAN CERTIFICATION AGENCY" LLC