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Class III Medical Device Registration in Russia

M

Masey B

#1
Hello All,

We have a Class III Medical Device which is currently undergoing review for CE mark. It is a wound dressing which contains an antimicrobial agent hence its classification. The Design Dossier has been reviewed and approved by our NB and is now being reviewed by the MHRA.

We are considering registering the device in Russia, I have had a look at the registration process and the steps involved but was wondering if anyone would have a rough idea of how long (on average) one might expect the registration process in Russia to take? I understand this might be a bit like asking "how long is a piece of string?" but a rough idea would help us greatly in our planning schedule.

If anyone has any other advice on device registration in Russia it would be much appreciated.

Thanks a million for your help :)
Masey
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
A quick "Bump" in case someone here can help with this one. My Thanks in advance!
 
M

Masey B

#5
Thank you so much for your help, it's much appreciated!!!

You're an absolute star :)
Masey
 

apuigvert

Involved In Discussions
#6
Hello all! I have to register a medical device including gentamicin. Could anyone advise if it is mandatory to register the drug before the medical device submission and how long would it take?

Is there a shortcut to register both products together (medical device and drug)?

Thank you very much in advance!
 
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