Russia - Medical Device Regulation Including Definitions Needed

[KMM2018]

Hello Elsmar Cove -

We are in need of the definitions, per current Russian medical device regulation, of the following:
1. Medical Device
2. Monitoring Device
3. Telemedicine

We also need an English translation of the current Russian medical device regulation.

If you know where I can find the above information, or if you have it to provide, it will be greatly appreciated.

Karen

 

[AnaMariaVR2]

Russia's Federal Service for Surveillance in Healthcare

Russia's Federal Service for Surveillance in Healthcare (Medical Devices)

The Medical Device Approval Process in Russia
Emergo Group

Medical Device Regulations in Russia and Eurasian Union

MEDICAL DEVICE REGISTRATION IN RUSSIA
RUStandard

 

[KMM2018]

Thank you, AnaMariaVR2 for all of these links. I have used them and found some very helpful information. Your help is much appreciated.

 

[craiglab]

You might also want to attend the ORCA webinar on the 25th "Medical Device and IVD Product Registration in Russia. Single Market Within Eurasian Economic Union"
Medical Device and IVD Product Registration in Russia. Single Market Within Eurasian Economic Union - Current/Future Events - Organization of Regulatory and Clinical Associates