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IVD Registration requirements in Russia

R

RChoudry

#1
Hi everyone,

I'm looking for some information regarding IVD registration in Russia. From requirements given to me by a potential local rep, we are required to provide test reports from accredited testing labs for a set of IEC 60601 standards. From my understanding these standards are for near-patient medical devices, which our product is not. Does anyone have any information regarding the required standards for in-vitro diagnostic devices in Russia? Also, is there any leniency in the lab providing the tests? Will they accept testing performed by the company itself?

Thanks for any info!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi everyone,

I'm looking for some information regarding IVD registration in Russia. From requirements given to me by a potential local rep, we are required to provide test reports from accredited testing labs for a set of IEC 60601 standards. From my understanding these standards are for near-patient medical devices, which our product is not. Does anyone have any information regarding the required standards for in-vitro diagnostic devices in Russia? Also, is there any leniency in the lab providing the tests? Will they accept testing performed by the company itself?

Thanks for any info!
Hello and welcome to the Cove :bigwave:

Have you already looked at this thread?
http://elsmar.com/Forums/showthread.php?t=35844

Also look at the table at the bottom of this page, perhaps other threads mentioned there will be of help.

Plus, I did a quick web search on "Russia medical devices" and many pages came up that seem relevant. I didn't go through the content, but here's an update that seems important:

http://www.emergogroup.com/blog/201...ssian-medical-device-regulations-planned-2013

Note: I'm not affiliated with Emergo in any way whatsoever.

Cheers,
Ronen.
 
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