Consumer Electronics, Health Care, Regulatory Affairs

10/ 01/ 2018

The Association welcomes the adoption and publication of the Government Resolution No.1027 dated December 20th, 2017. The Association’s experts took an active part in elaboration of this Resolution in order to enable economic entities to place an ID number of the assigned conformity assessment body in both the format of UA.TR.YYY and YYY as a reduced format when marking the products.

Adoption of the Resolution is essential for a number of industries, including medical devices, consumer electronics, cosmetic goods and others. In particular, it will now be allowed not to make any additional changes into the marking of electronic goods and thus, not to re-adjust the manufacturing process. In addition, the Resolution resolves a problem with the products that are already marketed with the reduced ID number format YYY. This problem already had a negative impact on availability of medical devices aimed at patients’ needs. Moreover, product marking in the format of UA.TR.YYY requires more space and therefore, is inconvenient for small items. For example, it is the reduced format that is used for the product marking in the member states of the European Union.

In view of this, the Association actively supported the elaboration and adoption of the Resolution. In our opinion, the adoption of the Resolution contributes to the improvement of the regulatory sphere and the final leveling of tension in the market of medical devices.

We are grateful to the Ministry of Economic Development and Trade of Ukraine, Ministry of Health of Ukraine, the State Service of Ukraine on Medicines and Drugs Control and other involved state authorities for constructive cooperation. We are also looking forward to timely and proactive actions from the side of responsible authorities to contribute to no emergence of any unexpected market problems further on.

For reference:
UA – a symbol of Ukraine in Latin characters;
TR – a symbol of the conformity assessment body;
YYY – a reference number of the assigned conformity assessment body

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