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

Partnership

The State Enterprise "SMCC" by the Ministry of Health of Ukraine has an agreement with TÜV SÜD and DQS Medizinprodukte GmbH, which can recognize the results of conformity assessment on the basis of certificates in accordance with the rules of the contract. Matching documents can be:

  • Certificates of conformity    
  • Design certificates    
  • Type certificates    
  • Certificates for the quality management system    
  • Technical Documentation Review Reports    
  • Audit reports on quality management systems

 

 

Ukraine and the European Union signed on 27 June 2014 the economic part of the Association Agreement between the European Union and the European Atomic Energy Community and their member states (hereinafter referred to as "AA"), according to which:


- Ukraine and EU member states intend to strengthen their cooperation in the field of technical regulations, standards, metrology, market surveillance, accreditation and conformity assessment procedures with a view to increasing mutual understanding of their respective systems and facilitating access to their respective markets (Article 55 (1) AA);

- Ukraine committed to take the necessary measures in order to gradually achieve conformity with EU technical regulations and EU standardization, metrology, accreditation, conformity assessment procedures and the market surveillance system, and undertook to follow the principles and practices laid down in relevant EU Decisions and Regulations (Article 56 (1) AA).

- In their cooperation, the Ukraine and EU seek to identify, develop and promote trade- facilitating initiatives which include, inter alia, promoting and encouraging cooperation between their respective organizations, public or private, responsible for metrology, standardization, testing, market surveillance, certification and accreditation (Article 55(2)(b) AA).

- Ukraine shall progressively transpose the corpus of European standards (EN) as national standards, including the harmonized European standards, the voluntary use of which shall be presumed to be in conformity with legislation listed in Annex III to AA (vertical (sectoral) legislation on medical devices, active implantable medical devices, and in vitro diagnostic medical devices - during the 3 year period after the AA’s coming into force). Simultaneously with such transposition, Ukraine shall withdraw conflicting national standards, including its application of interstate standards (GOST), developed before 1992 (Article 56 (8) AA).