Health Care

09/ 10/ 2018

28 Standards were included into the National Standardization program – 2018

Association’s Healthcare Committee would like to thank Mineconomy for the constructive collaboration regarding numerous issues and the reached success concerning standardization activities.

Mineconomy was appointed as responsible for the National Standardization Body establishment. From the beginning of 2015 the functions of such a body were assigned to State Enterprise “Ukrainian Scientific Research and Training Center for Standardization, Certification and Quality Problems” (SE “UkrNDNC”). On June 6, 2018 SE “UkrNDNC” issued an Order #154. The Order included 28 standards, recommended by the Association’s Healthcare Committee, to the National Standardization Program for 2018 by cover method. Overall Association’s Committee recommended 31 standards for acceptance and we are grateful that most of them are already included.

In Ukraine all medical devices must go through conformity assessment procedure with one of the Technical regulations on medical devices [1] before they could be placed on the market. However, some standards, necessary for assessment procedure conduction, are not adopted in Ukraine yet. Association’s Healthcare Committee hopes that the standards, which are not a part of our legislation, will be adopted as soon as possible for the sake of approximation of the national standard system with the European norms and rules.

Formerly, European Business Association transmitted to state authorities the list of standards, which are necessary for a smooth medical devices market functioning in Ukraine. Representatives of the Association’s Healthcare Committee believe that adoption of necessary medical devices standards is a crucial issue for unobstructed conformity assessment procedures. Such a step would bring more high-tech and high quality medical devices to the Ukrainian market.

Association’s Healthcare Committee expresses its’ gratitude to Mineconomy for the assistance with the inclusion of the necessary standards and hopes for future fruitful collaboration.

[1] Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02 October 2013, Technical Regulations on Medical Devices for In Vitro Diagnostics approved by Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02 October 2013, Technical Regulations on Active Implantable Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 755 dated 02 October 2013.

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