BW announces the webinar will be held on 21th of December from 12:30 p.m to 02:30 p.m.(Moscow time).

Agenda:

12:30-01:30 «Registration of medical devices and IVD products in Russian (current procedure)»

• Basic registration analysis,
• Legislation framework,
• Classification rules,
• Registration process depending on risk class,
• Documents from manufacturer side,
• Basic understanding of pre-clinical and clinical trials,
• Declaration issues.

01:30-02:30 «Single market of medical devices and IVD products within Eurasian Economic Union (expected changes)»

• Transition period clarification,
• Legislation base,
• Essential requirements to safety and performance,
• Applied classification,
• Basic understanding of registration process,
• Quality Management System requirements,
• Safety monitoring (surveillance),
• Comparison of current registration in Russia and EEU procedures,
• Critical points of single market.

For details please contact to Ruslan Kalachev: Ruslan.Kalachev@beawire.com; +7(499)281-67-68 ext. 101.