Registration of medical devices continues according to national rules

At the suggestion of the Republic of Kazakhstan, a decision was made by the Council of the Eurasian Economic Commission to preserve the possibility of registering medical products under the terms of national regulations until the end of 2025.

It should be noted that the member states of the Eurasian Economic Union, in order to create a barrier-free environment in the medical products market, adopted uniform rules for the registration (re-registration) of medical products in 2014. The transition to the new uniform rules for the EAEU countries for re-registration and registration of medical products intended for circulation in the territory of the EAEU countries was planned to be carried out from the beginning of 2023.

However, the current economic circumstances, as well as the pandemic period, have negatively affected the readiness of domestic producers to switch to the EAEU Rules.

This solution will allow domestic manufacturers to produce and register medical products according to the usual requirements. This will prevent the risk of a shortage of medical products, including a positive impact on the pricing of medical products in the Republic of Kazakhstan.