The Government Has Approved the Rules for Determining the Cost of Assessment of Medical Products Compliance with Technical Regulations Requirements

On July 12, 2017, the Cabinet of Ministers of Ukraine adopted Resolution No. 514 "On Approval of the Rules for Determining the Cost of Assessment of Medical Products Compliance with Technical Regulations Requirements implemented by designated compliance evaluation agencies and Recognized by Independent Organizations".

The rules define the formula by which the costю of services related to assessment of medical products compliance with technical regulations is calculated. It should be noted that the expenses associated with the purchase of special materials, components, the costs of contractors, transport and customs payments, and other expenses can be included in the cost of the assessment services. However, in order to include such expenses, the availability of the costs should be agreed by the parties prior to beginning the work, and the expenses themselves shall be documented by the executor for subsequent reimbursement.

The rules also provide for the possibility of reviewing the components of calculating the value of compliance assessment in case if the appropriate amendments are made to legislative acts, changes in the amount of expenses affecting their value (increase in minimum wages, tariffs for energy carriers, prices for materials and raw materials, Etc.). At the same time, such revision is not possible more often than once a year, and as a rules, shall take place before October 1, but not later than December 1 of the current year.

Let us remind you, that since July 1, 2017, the period of transition from the procedure for state registration of medical products to the procedure for assessing compliance expires. Therefore, since July 2, 2017 the medical products legalization in the territory of Ukraine shall take place through the assessment procedure for compliance with technical regulations.