Many key regulatory changes and initiatives were undertaken in the local regulatory systems of Russia and Kazakhstan last year, in parallel with the development of the Eurasian Economic Union (EAEU) harmonized system of medical device regulation. Moscow-based regulatory specialist Alexey Stepanov tells Medtech Insight that no official extension has yet been granted for the EAEU system, and meanwhile the two most active regulatory systems within the five member-state group continue to improve their national infrastructures. (Also see "Eurasian Medtech System Still 'Officially Targeting' 2021 Deadline" - Medtech Insight, 25 January, 2019.) (The Eurasian Economic Committee (EEC) has recently developed an English-language website on rules and news for medtech stakeholders.)
One of the most significant improvements in Russia in 2018 was the release of Resolution No 633, dated May 31, on amendments to the rules of state registration of devices (amending regulation No. 1416 of 2012), which simplified the registration process for in vitro diagnostics in Russia, says Stepanov. Entering into force on June 13, it effectively implemented a one-step assessment process – in place of the two-step process – for all classes of IVDs
