A must read blog if interested in Russia pharma and device development
Here is my monthly newsletter with the most important regulatory updates on medical devices in Russia and the Eurasian Union for August 2018.
1. Potential Changes in the Eurasian Medical Device Transition Period for certain group of devices
On 6 August 2018, the Eurasian Commission published a draft regulation (link in Russian) that suggests prolongation of the validity of the medical device registration certificates of Eurasian member states for certain group of devices after the end of the Eurasian transition period.
According to Article 11 of the Agreement on the Uniform Principles and Rules Governing Market Circulation of Medical Devices within the Eurasian Economic Union (signed on 23 December 2014 and enforced on 12 February 2016), registration certificates issued by member states prior to the date of enforcement of the agreement are valid no later than the end of the transition period set as 31…
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