Ukrainian Scientific Institute of Certification

Ukrainian Scientific Institute of Certification Accredited as Notified Body

07/09/2015

On 4 September 2015, the Ukrainian Scientific Institute of Certification (Uni-CERT) was granted an accreditation certificate by the National Accreditation Agency of Ukraine to carry out the conformity assessment of medical devices and was designated by the Ministry of Economic Development to carry out the assessment of conformity with the Technical regulation on medical devices (Resolution No. 753 of the CMU of 2 October 2013) and Technical regulation on in vitro diagnostic medical devices (Resolution No. 754 of 2 October 2013).

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Uni-CERT was also accredited to certify quality management systems in the following areas:

  • non-active medical devices;
  • active non-implantable medical devices;
  • active implantable medical devices;
  • in vitro diagnostic medical devices;
  • medical device sterilisation methods;
  • devices utilising specific substances/technologies.

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