Health Care

26/ 02/ 2019

38 medical devices’ standards are in the National Standardization Program 2019 We are pleased to announce that the State Enterprise “Ukrainian Scientific Research and Training Center for Standardization, Certification and Quality Problems” (SE “UkrNDNC”) took a positive decision to include 38 out of the 41 medical devices’ standards proposed by the European Business Association Health Care Committee (Association’s Committee) into the National Standardization Program for 2019. 3 (three) more standards have been already adopted and are applied in Ukraine. In order to be placed on the market of Ukraine, all medical devices must go through the conformity assessment procedures to prove compliance with one of the Technical Regulations on Medical Devices[1]. It is known that certain medical devices’ standards required for such a conformity assessment procedure have not yet been adopted in Ukraine. Their adoption is essential for the smooth conformity assessment procedures and will promote bringing new high-quality medical devices to Ukraine. Association’s Healthcare Committee expresses its’ gratitude to Mineconomy and the SE UkrNDNC for the understanding of the need to upgrade standards as well as adopt those unavailable in Ukraine. We hope that the respective standards for medical devices included into the National Standardization Program for 2019 will be adopted as soon as possible and we hope 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.

38 medical devices’ standards are in the National Standardization Program 2019

We are pleased to announce that the State Enterprise “Ukrainian Scientific Research and Training Center for Standardization, Certification and Quality Problems” (SE “UkrNDNC”) took a positive decision to include 38 out of the 41 medical devices’ standards proposed by the European Business Association Health Care Committee (Association’s Committee) into the National Standardization Program for 2019. 3 (three) more standards have been already adopted and are applied in Ukraine.

In order to be placed on the market of Ukraine, all medical devices must go through the conformity assessment procedures to prove compliance with one of the Technical Regulations on Medical Devices^[1]. It is known that certain medical devices’ standards required for such a conformity assessment procedure have not yet been adopted in Ukraine. Their adoption is essential for the smooth conformity assessment procedures and will promote bringing new high-quality medical devices to Ukraine.

Association’s Healthcare Committee expresses its’ gratitude to Mineconomy and the SE “UkrNDNC” for the understanding of the need to upgrade standards as well as adopt those unavailable in Ukraine. We hope that the respective standards for medical devices included into the National Standardization Program for 2019 will be adopted as soon as possible and we hope 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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