Hi Scott,
I have to say, after working with several consultants in Russia, that their approach is more of "couriers" walking documents from manufacturers to authorities, rather than really providing expertise and truly consulting services.
The highly reputable international consulting companies have decreased their local presence in Russia, due to the same reasons - the quality of the consultants there impact their outstanding image in other markets.
As a first step, I suggest getting in touch with the industry trade association there - IMEDA -
http://en.imeda.ru/, their English page offers less info compared to Russian one, but it does offer you a good insight of most important regulations. Even if your company is not interested in a membership or at least not immediately, I always like to 'test the waters" and ask to be an "observer" (which they normally agree) and this status shall give you the opportunity to interact with other members and as well get some input, especially legal advice, from an objective source. Mikhail Potapov, Imeda Legal Director is extremely supportive and helpful.
Secondly, if you are working with a consultant there already, get ready to challenge everything you are told , from the no of dossiers they are trying to get out your documentation, up to the information they provide, even in terms of documentation needed to support product registration.
The recent example I have is the consultant wanting to waiting 3 months before submitting a complete application file for an amendment of the registration certificate, because an ISO 13485 of a mfg site was due to expire in 3 months! I had to push on getting the submission executed and prepared a letter for Roszdravnadzor explaining the new ISO will be submitted as soon as new ISO will be ready and guess what - I already received the amended registration cert (in 15 days!).
Regarding pricing - this info is publicly available on Roszdravnadzor website - this year the registration fees increased about 15% compared to last year (govt fees), but if you consider Ruble devaluation, then it's less expensive to register a device in Russia now compared to last year (35-50% less).
For capital equipment - registration costs this year shouldn't be more than 10k, if your contracts are negotiated in Rubles.
Hope this helps,
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Ondina Maria Iovicin - Grigorescu RAC
Montreux
Switzerland
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Original Message:
Sent: 03-25-2015 13:10
From: Scott Paulson
Subject: Product registration in Russia
Hi Ondina,
Do you have recommendations for a trustworthy and knowledgeable device registration consultant in Russia? For a long time we have used the regulatory registration department of our distributor, but I believe that we are being charged a much higher price for each product registration than we should be.
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Scott Paulson
Director, Regulatory Affairs
FUJIFILM Sonosite, Inc.
Bothell WA
United States
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Original Message:
Sent: 03-24-2015 07:03
From: Ondina Maria Iovicin - Grigorescu
Subject: Product registration in Russia
Hi Diane,
the costs you list below are way too high, especially if you consider the Ruble devaluation. Overall, registration of a medical device in Russia varies between Eur 15,000 and 10,000, depending on device risk class (class III being most expensive).
Not sure what "new labeling requirements" your distributor refers to, there are few regulations coming into effect in Jan, but none referring specifically to labeling.
What product risk class is your device, as per EU classification?(despite Russia not acknowledging EU regulations, the classification is very, very similar, so can be used as a starting point).
Who is performing registration - is it your distributor or a consulting agency?
I am happy to support with additional info.
thanks,
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Ondina Maria Iovicin - Grigorescu RAC
Montreux
Switzerland
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Original Message:
Sent: 03-23-2015 14:46
From: Diane Rogers
Subject: Product registration in Russia
Is anyone experiencing problems with new regulations for registration of medical devices for Russia? Our distributor is telling us of expensive Biocompatibility, bench testing, clinical review and initial registration fees of $13,000 EU plus, all new labeling requirements that went into effect in January. Does anyone have a link in English to these new requirements?
Thanks very much!
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Diane Rogers
Manager of Regulatory and International Affairs
Ultradent Products Inc.
South Jordan UT
United States
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