Medical Device Registration Process in Russia

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Muazzam ALi

Dear Sir/Madam,

How are you ?Hope you will be fine!

We need your guidance and kind assistance.

We have Russia medical devices certificate of Roszdravnadzor from many years.

Now we want to change our distributor and also amendment the certificate where our distributor name mention.

We want to amendment our name in the name of our distributor ,so that we can sell our instruments to others Russian companies also.

Is it possible we can amendment this in certificate ??

If possible then please advise us procedure and charges for that.

We will highly appreciate for your help.

Awaiting for reply via email.

Best Regards,

Engr. Muazzam Ali

(Mechanical Engineer)

ALLEN SURGICAL CO. (PVT) LTD

T:+92-52-3256272

E:[email protected]
 
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belemsanchez

Please, I need help regarding who must be the owner of a MD registration in Russia.

I'm not sure if now the Manufacturer may change the owner of the Registration Certificate or not. Someone has alerted me about in Russia you "get marry" your distributor because later it's imposible to change the registration, is it correct? or we can trust in our russian holder, and request the issue the Registration certificate under holder name?

Thanks in advance¡¡
 
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Amy Wong

Hello Guys,

We are wondering if our MRI for Veterinary is considered as a Medical Device in Russia:

1) Is there any registration need for Veterinary Device before shipping to Russia?
2) Can it be a direct sale from a HK company to the Veterinary Hospital without the need importer / distributor to handle the shipment ? or there's a need to to do (importer)?

Please drop in some comments if you have more information.
Thanks a lot.:thanx:
 
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