Medical Device Registration Process in Russia

Hello Everyone:

Our Moscow office recently wrote a very detailed overview of the Russian medical device regulatory process for the Journal of Medical Device Regulation. I thought forum members might find it to be helpful.

The process is very complicated so the article is about 3,700 words long but provides a good overview of what is involved. We are also working on a regulatory flowchart that I will share with members once we have it completed.

Regards,

Chris Schorre
Emergo Group, Inc.

Does Roszdravnadzor's post market surveillance requirement (page 7 of the PDF) require and allow reporting of incidents anywhere, or only within the Russian Federation? Does their requirement emphasize speed of reporting even if facts are not yet certain, or does it permit delay until facts and fault are understood? Does it disclaim liability determination in regard to the Russian legal system?

MIREGMGR said:

Does Roszdravnadzor's post market surveillance requirement (page 7 of the PDF) require and allow reporting of incidents anywhere, or only within the Russian Federation? Does their requirement emphasize speed of reporting even if facts are not yet certain, or does it permit delay until facts and fault are understood?

Click to expand...

After reviewing the Order No. 735, my understanding is that it is not specifically restricted to incidents in Russian Federation. Withing 5 working days from the incident reporting, registration dept. manager has to provide detailed report to head of Roszdravnadzor regarding the incident. The head of Roszdravnadzor within 5 working days after receiving the report or further data regarding the investigation results, can take the decisions detailed in the page 7.

Hello all,

Excellent document. Is it still valid or maybe there was some changes in meantime?

Are there any other guidance documents for Russian market regarding single-
use medical devices class I, Is and IIa (products made of gauze and cotton wool)?

Does anybody know is there some necessary regulations for importing simple hygienic products (cotton wool products) to Russian market?

Thank you all in advance
Ana

The original article written by Emergo Group on Russia has changed somewhat in that Hygienic Certificates are no longer required. You can see an updated PDF that shows the Russian regulatory process (and 9 other markets) here: http://www.emergogroup.com/literature

Chris

Thank you Chris for a very informative article.

Dear All,

Thank you for this very interesting thread so far,

I am due to commence re registration for a class IIa medical device in Russia.

What if any differences are there between initial registration and re registration? Such as cost, timescales, is there an audit required?

If anyone could shed some light on this it would be greatly appreciated

Many thanks
Ray

Word to the wise...hire a certified translator to confirm that documents in Russion match the English versions and that you agree with it before signing anything.
Medic

Just a concern- What would be the tentative cost and time frame for registrtion of Class I and II ( FDA)in Russia. Anyone who could help us with this?

Plus the translation fees for documents? SAy per page/ in Euro or US $ .

Thank you in advance

I don't think you can figure out the costs ahead of time. We spent 16,000.00 USD and still had to pay for an attorney in Russia to complete the project. The attorney has to hold the registration certificate in case the government needs it again. We do not want the customer to keep it. The attorney's office did the translations. I hope the customer will spend enough with us this year to make up for it.
I wish you luck!
Medic