Since June 2015 the rules on the market of medical devices of Ukraine have changed. So, in the first line we would like to inform you that the procedure of the registration of medical products in Ukraine has been cancelled since  1.07.2015 – in lieu of it the procedure of assessment of the compliance of medical products with  the Technical regulations has been introduced, which has been harmonized with the European Guidelines and CE Standards. At the same time even the availability of CE mark on the foreign-made product would not grant any preferences to its manufacturer or supplier – Ukrainian legislation demands to assess  the compliance of medical products with  the Technical regulations also in Ukraine. 

So, nowadays in order to put into operation and supply in Ukraine of new kinds/types/brands of the  medical products it is necessary to obtain from the manufacturer the Declaration of Compliance and obtain the assessment of compliance with  the Technical regulations from the certification authority.

According to the Decree of Ministry of Economic Development and Trade of Ukraine of 11.11.2016 № 1898№1899, 1900  (English version)“On appointment of authorities for products compliance assessment with the technical regulations”, IMPROVE MEDICAL   was appointed as the Conformity assessment  Body under No. UA.TR.120 for conformity assessment of medical devices, processes and services with the following technical regulations:

– Technical Regulations for medical devices, approved by the Resolutions of the Cabinet of Ministers of Ukraine of 02.10.2013 No. 753;
– Technical Regulation for in vitro diagnostic medical devices, approved by the Resolutions of the Cabinet of Ministers of Ukraine of 02.10.2013 No. 754;
– Technical Regulation for active implantable medical devices, approved by the Resolutions of the Cabinet of Ministers of Ukraine of 02.10.2013 No. 755.

To obtain the Cost of works on Conformity Assessment with the Technical Regulations for Medical Devices, you need to provide the required list of documents, as well as the forms completed. See the links below.

The list of documents required from the manufacturer of medical devices.

APPLICATION for Conformity Assessment with Technical Regulations for Medical Devices.

Essential requirements checklist according to TR

Please send us the completed forms and the necessary list of documents to the following email address: improvemedua@gmail.com.
Our experts will need only one day to make the decision and the estimate of works.
Should you have any questions on selection of the procedure for Conformity Assessment and filling out forms, please call us at +38 044 355 50 30. The experts of Improve Medical are always pleased to inform on application of Ukrainian legislation in the field of technical regulation.