Registration of MD and IVD products in Russia and EAEU
BW announces the webinar will be held on 21th of December from 12:30 p.m to 02:30 p.m.(Moscow time).
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.