On January 22, Order of the Ministry of Health of Ukraine No. 142 “On Approval of Methodological Recommendations on Application of Technical Regulations on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013, Technical Regulations on medical devices for in vitro diagnostics approved by Resolution of […]

The transition period for placing of products into circulation with measuring information in SI units on the labeling will come to an end in 11 months, on 01.01.2021. The requirements of the Order of the Ministry of Economic Development No. 914 of 04.08.2015 apply to all products that will be placed on the market of […]

In accordance with the Association Agreement, Ukraine is harmonizing their legislation with Eropean Union. As a result, within 2019 in Ukraine several legal acts came into force establishes the legal and organizational basis for providing consumers with information and affected the labelling of food products, including dietary supplements, child and medical foods. We have issued […]

We would like to inform you on the recent news concerning the food products in Ukraine. The Language Law. On July 16, the Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as State Language” came into force. The law stipulates that the only state (official) language in Ukraine is Ukrainian language, however it […]

News under the tag “Brexit” appear in Ukrainian mass media more and more frequently, describing various aspects of the UK politics and economics. Considering new development vector of any country, first of all we must consider the political process with hardly predictable multi-level impact on certain economic realm, industries and production. It is important not […]

About three years ago the first Agreement on recognition of conformity assessment results was signed by notified body TÜV SÜD. This agreement started national conformity assessment of medical devices from the European market in a faster, more economical and transparent way. At the present moment about 30 EU notification bodies have signed such Agreements with Ukrainian […]

We inform you on the most actual news regarding medical devices in Ukraine in June, July and August 2019.  Technical regulations and market surveillance. On July 3, amendments to the Law of Ukraine ‘On Technical regulations and conformity assessment’ came in force. Amendments were introduced under the Law ‘On amendments to certain legislative acts of Ukraine […]

n this digest you will find the most important news on registration, safety and quality management of medicinal products in Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan, which entered into force at the end of 2018 and in the first half of 2019.   The most significant news in brief: In Armenia On […]

Joint seminar related to the influence of new language policy on the medical market operators has been hosted by Cratia and Association of Medical Device Market Operators (www.amomd.com). On the event we spoke on the influence of Law of Ukraine dd April 25, 2019 “On assurance of functioning of the Ukrainian language as state language” […]