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Registration Requirements for X-ray & Oncology Product in Russia

S

sadiesmom

#1
Hello Cove,

I am having a very difficult time trying to locate information in regards to registering x-ray equipemnt only with oncology equipment. What I'm trying to locate are the regulations or requirments to register radiation emitting products.

I hope someone can guide me in the right direction.

Sadie's mom
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#3
Hi Sadie's mom

Welcome to the cove!!!

In addition to Arios's post, please refer attached flow chart on "Medical Products Registration process with Russian Federation"

Hope you will find useful.
 

Attachments

sreenu927

Quite Involved in Discussions
#4
Thanks to Arios and Subbu..

In addition to the above, pls note below pointers:

--Include the Classification of the device (X-ray devices fall under Class IIb as per Russian regulations).
--Application must be submitted in 3 hard copies and 1 electronic format
--most of the documents must have Apostille (legalization from the Country of Manufacture)
--All documents submitted to the Ministry of Health must be in Russian. If original documents are drafted in another language, certified translations should be provided.
--Proof of payment of government registration fee
--Applicant's Company business license

As you can observe from the registration process flowchart provided by Arios:
It is important to note that the submission requirements do not vary among different device risk classes. The same set of documentation is submitted to the regulators.

Fees: Fees will be determined on case-by-case basis. Typically the total expenditure for registration process may vary from USD 1000 -USD 75000.

Regards,
Sreenu
 

Attachments

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