We are glad to announce the workshops which will be held during Arab Health and Medlab in Dubai.
|10:30-11:15||Main Point of Russian Market Access||Ruslan Kalachev|
|11:15-12:00||Registration in Single Market of Eurasian Economic Union||Ruslan Kalachev|
|12:00-13:00||Reception||Tatiana Nosova, Ruslan Kalachev|
1st Session. 10:30-11:15
Main Point of Russian Market Access
Despite the fact that Russia is the member state of Eurasian Economic Union and national registration system will be replaced by single market within Eurasian Economic Union after 2026, each year, Russian regulator Roszdravnadzor changes legislation in current national registration system. At least for 2017-2019 years few of such changes have significantly influenced the industry (e.g. registration of devices with pharmaceutical content was stalled more than for one year). Some of the rules are non-official, it means that practical experience is only one way to understand how the whole registration process works. Getting these points may be converted in appropriate market access strategy.
-registration tracks depends on risk class,
-procedure of samples importation,
-successful strategy to verify clinical performance,
-declaration issues after registration,
-best practice in relationship with sales partners.
2nd Session. 11:15-12:00
Registration in Single Market of EEU (ARM, BLR, KAZ, KGZ, RUS)
The main idea of Eurasian Economic Union single market is initially the same with EU CE mark- to be approved in all EEU member states by one registration procedure instead of applying for each approval according to national registration procedures which are totally different. Eurasian Economic Commission have announced launching of single market for several times during last years but the first registration was finally issued on Dec, 2019. Which system to choose for registration: national Russian or register in frame of Eurasian Economic Union regulations? When registration certificates issued in Russia will expire? These and other questions will be answered during the EEU session.
-transition period issue,
-authorized bodies of member states,
-essential requirement to safety and performance,
-recognition of expertise conclusion issued by reference state,
-factory inspection requirements,
-surveillance after registration,
-difference between national registration system in Russia.
Please contact to Ruslan in case of any questions Ruslan.Kalachev@beawire.com