The Ukrainian Scientific Institute of Certification provides information services exclusively within its competence related to medical devices, personal protective equipment and certification of quality management systems. Thanks to the experience of cooperation with the largest suppliers and manufacturers on the Ukrainian market, concluded agreements on the recognition of the conformity assessment results with leading European notified bodies, UNI-CERT specialists are among the most qualified in this industry and can answer almost all questions that arise. They are versed in national and international legislation in the field of technical regulation at a high level, including in its original language.

The main list of provided information services is as follows:

• Confirmation of product compliance with the definition of a medical device, in vitro diagnostic medical device, accessory, based on its intended use and indications for use, as well as confirmation of the correct classification of such products by the manufacturer, in accordance with the definitions set out in:

1. Technical regulations on medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 753 dated 02.10.2013
2. Technical regulations on in vitro diagnostic medical devices, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02.10.2013

• Clarifications for government agencies, tender committees, etc.

The usual term for the provision of the service is from one to three working days after the submission of all the necessary documents and payment.

We will be happy to answer your questions, you can contact us on the contact page.