Russian, Ukranian, Bellarusan, Kazakhistan Certificates (Gost-R, Gost-K, UkrSepro)

R

russianGostR

#1
Hello All

Even if you prodcuts complay with CE,ISO...etc still for Russian,Ukranian,Bellarusan, Kazakhstan you will be need local certificate from local notified body

regarding mentioned countries and standard if you have any question, comment please let me know i can assist you

i am certification specialist from notified body in Moscow Russia, i will gladly answer all of your question

Cheer

Richard
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Re: Russian,Ukranian,Bellarusan,Kazakhistan Certificates(Gost-R,Gost-K, UkrSepro)

I am allowing this post to stay for now, but I want to make clear this is not a forum for advertising services. If you are interested in helping people here in the forums with their questions, you are very much welcome here. If your main intent is to drum up business (rather than to help people here in the forums), this is not the place where such advertising is allowed.

Will you please briefly tell us about Gost-R, Gost-K, and UkrSepro? As I understand it Gost-R are Russian medical device regulations. What are the other two?
 
R

russianGostR

#3
Re: Russian,Ukranian,Bellarusan,Kazakhistan Certificates(Gost-R,Gost-K, UkrSepro)

I am allowing this post to stay for now, but I want to make clear this is not a forum for advertising services. If you are interested in helping people here in the forums with their questions, you are very much welcome here. If your main intent is to drum up business (rather than to help people here in the forums), this is not the place where such advertising is allowed.

Will you please briefly tell us about Gost-R, Gost-K, and UkrSepro? As I understand it Gost-R are Russian medical device regulations. What are the other two?
Dear Marc
GostR or GostTR obligatory certificate for every products enter Russia so if you want to sell any products you must have GostR certificate thats first rule to do business with Russian and former soviet countries.

secondly if your products medical device then beside GostR you will also bee need GostRegistratze (hygienic certificate)

lets says your products uses in petroleum industry then beside GostR you need RTN certificate (Rosthecnazor )

GostK is same thing but requested for Kazakhstan

UkrSepro again for Ukraine, if you want to sell something to Ukraine you must have UkrSepro


i am really busy at the moment but if you have any question let me know i will write with detail later

regards
 
H

hrrvett

#4
Re: Russian, Ukranian, Bellarusan, Kazakhistan Certificates (Gost-R, Gost-K, UkrSepro

I am looking at potentially exporting an investigational class ii device (US classification) to Russia and Ukraine.

Could you please provide a brief overview of the registration process for Russia and Ukraine assuming the intent is to market the device in Russia / Ukraine?

Also, is the process different if we want to use the device for investigational purposes (clinical studies) rather than for sale in Russia / Ukraine?

Thank you.
 
L

Liz G

#5
Re: Russian, Ukranian, Bellarusan, Kazakhistan Certificates (Gost-R, Gost-K, UkrSepro

This post seems to be inactive, but I am interested to know whether or not Kazakhstan and/or Ukraine have requirements for notification/re-registration of changes to medical devices and, if so:
  • What type of changes (e.g. labeling changes, material changes, etc.) require notification/re-registration;
  • The cost of change notification, if any; and
  • The approval time for changes, if any.
Thank you!
 

tibon74

Involved In Discussions
#6
Re: Russian, Ukranian, Bellarusan, Kazakhistan Certificates (Gost-R, Gost-K, UkrSepro

Hello,

Does someone have information about medical device registration requirements in Kazakhstan?
thank you!
 
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