Expertise and experience
Helping you put the piece in the puzzle
Let our experience help and support you through
the Russian medical devices registration process
Three Unique reasons
to let BSI help you
registration in Russia
We have a wealth of experience
in helping medical device
manufacturers achieve their
product registration with the
Russian Regulatory Authorities.
We have Russian speaking
technical experts who can help you
to ensure your product registration
documentation is fully aligned with
the requirements of the RRA.
At BSI we understand the
importance for companies wishing
to sell into new markets. Our
Russian market access programme
will help you to stay ahead of the
At BSI we fully understand the challenges that manufacturers face when looking to
access new markets. In today’s world manufacturers need to increase their global
footprint as markets become more and more competitive.
The Russian registration programme has been designed to help manufacturers
successfully navigate their route to receiving product registration in a timely
To achieve successful registration it is critical that you work with a market leader
who fully understands the processes and procedures. The Russian medical device
registration process is very complex and most of the documentation is not in
English, discussions about your product registration are normally face to face
in Russia with the authorities. Our in-house technical experts work closely with
our Russian based authorised representatives to ensure the transferring of your
product documentation into Russian is to the highest possible standard.
Your completed Dossier will be hand delivered to the Federal Service for Control of
Healthcare and Social Development (Roszdranadzor)
for final review. If your submission has been successful
you will receive your confirmation letter.
When you choose BSI to support your business you
know that you have the peace of mind in knowing you
are working with a premium global agency as effectively
demonstrated with its role as a Notified Body.
From day one you will have fast access to
experience and expertise giving you the
peace of mind in knowing that every step
taken is moving your business nearer to
accessing a whole new market.
Our goal is to assist you in making your
registration as important to us as it is to
you so that you can realise a faster return
on your investment.
The fast route into the Russian market
Identify the procedure
that is applicable to your
BSI provides a formal
Quotation to customer
BSI completes a full review
of all documentation
BSI works with Russian
Customer receives formal
notification that their application
has been successful
Russian business partner does final
consolidation of file and hand delivers to
Russian Ministry of Health
Customer signs quotation
and returns to BSI
Complete a BSI Customer
BSI translate all the
documentation into Russian
certification is issued.