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Верховна Рада України
Президент України
Уряд України
МОЗ України
ДЕРЖАВНА СЛУЖБА УКРАЇНИ З ЛІКАРСЬКИХ ЗАСОБІВ
Національне агентство з акредитації України

About us

State enterprise "State Medical Center Certification" by the Ministry of Health of Ukraine formed to ensure proper performance of the functions assigned to the Ministry of Health of Ukraine (Ministry of Health of Ukraine decree from February 18, 2009 No 42-0).

The Ministry of Health carries out the functions of technical regulation in: health, development, manufacturing, quality control and sale of medicinal products and medical devices including medical devices, medical products for in vitro diagnostics; implanted active medical devices (Cabinet of Ministers of Ukraine decree of December 18, 2015 No 1057).

SE "SMCC" by the Ministry of Health of Ukraine is the main organization of the Ministry of Health in developing of legal documents on conformity assessment quality management system implemented in health institutions (MH Ukraine decree from 29.09.2014 No 683).

On the base of SE "SMCC" by the Ministry of Health of Ukraine was established Standardization Technical Committee 181 "Dentistry. Quality Management System " (decree of national standards of Ukraine on October 18, 2016 No 333).

State enterprise "State Medical Center Certification" by the Ministry of Health of Ukraine (hereinafter - SE "SMCC" by the MH) is a legal entity, based on state ownership has accounts in Ukreximbank (The State Export-Import Bank of Ukraine, 100% owned by the state represented by the Cabinet of Ministers of Ukraine), and operates according to the Ukraine laws.

Location:

Legal - Victory Avenue, 120 m. Kyiv, Ukraine 03115;

Actual - lane Khotkevych Gnat, 2 a, m. Kyiv, Ukraine 02660.

SE "SMCC" by the MH accredited by the National Accreditation Agency of Ukraine for compliance with the requirements of ISO / IEC 17021 (in: certification of management systems in accordance with ISO 9001, EN 15224, ISO 13485) and ISO / IEC 17065 (in: certification of medical devices compliance with the Technical regulations on medical products, Technical regulation of medical devices for the diagnosis in vitro; Technical regulation on active medical devices implanted). Accreditation certificates valid until June 2019.

According to the Ministry of Economic Development and Trade of Ukraine decree from 20.05.2014. No 579 SE "SMCC" by the Ministry of Health of Ukraine appointed as Notified Body concerning Products Technical Regulations (assigned a unique number UA.TR.067):

• Technical regulations relating to active implanted medical devices (developed on the basis of Council Directive No 90/385 / EEC from 20 of June 1990);

• Technical Regulation on medical products for in vitro diagnostics (developed on the basis of the European Parliament and of the Council Directive No 98/79 / EEC from 27 of October 1998);

• Technical Regulations on medical devices (developed on the basis of Council Directive No 93/42 / EEC from 14 of June 1993).

SE "SMCC" by the Ministry of Health of Ukraine has enough number of auditors (in ISO 9001, EN 15224, ISO 13485), which are certified by the certification personnel of the Ministry of Economic Development and Trade of Ukraine, and accredited by the National Accreditation Agency of Ukraine in accordance with the requirements of ISO / IEC 17024. Also SE "SMCC" by the Ministry of Health of Ukraine has sufficiently experts in technical areas: health care and medical products.

SE "SMCC" by the Ministry of Health of Ukraine has agreements on recognition of conformity assessment with European notified bodies TUV SUD Product Service GmbH (from June 2016), DQS Medizinprodukte GmbH (from October 2016) and testing laboratory Siemens Healthcare GmbH, Corporate Testing Laboratory.