Emergo Group Expands into Russia, Helps Medical Device Companies Gain Access to Market of 140,000,000 People

February 25, 2009 - Increased demand from medical device companies in the United States and Europe have led Austin, Tex.-based Emergo Group to expand its medical device regulatory consulting services to the Russian Federation.

Emergo Group CEO Rene van de Zande says: “Our clients have been asking us to assist with medical device approvals in Russia because the market is very difficult for Western companies to penetrate on their own. Regulatory submissions must be conducted in Russian and little English language information is published on how the process works. Now that we have a highly experienced consulting team in Moscow, we are able to help Western companies gain access to this market.”

Russia is one of the few major markets worldwide that still rely on product testing as a means of determining the safety and efficacy of common medical devices, even products that have already been cleared for sale by the US Food and Drug Administration (FDA) or have European CE Marking approval.  As a result, advanced medical technology has been slower to permeate the Russian Federation than in Europe, Japan or the US.

Moscow presence facilitates faster medical device approvals

The process of getting a medical device approved in Russia takes from 4-9 months if working with an experienced local consultant. Mr. van de Zande notes: “Russian business culture necessitates face-to-face meetings with officials before and during the registration process so having a local presence is a huge advantage in getting things done more efficiently.” With their Moscow presence, Emergo Group is able to assist medical companies with all aspects of the Russian registration process including Technical Report preparation, GOST-R certificates, Hygienic certificates and other regulatory issues.

Independent representation allows manufacturers freedom to select, add and change distributors

Many Western companies have relied on distributors to help them navigate the bureaucratic Russian registration process. By doing so, however, the manufacturer and distributor are essentially married. This limits the ability of the manufacturer to seek alternative distribution options in the future. By using an independent consulting firm for registration, the manufacturer is free to select any distributor they wish, and change distributors at any time.

In addition to assisting companies with medical device registration in the Russian Federation, the company is also able to obtain approval in former Soviet Republics.

About Emergo Group
Emergo Group, Inc. is an ISO-registered consulting firm that specializes in assisting medical device companies with international regulatory approvals, quality assurance and distribution consulting. The company has more than 1,000 medical device and IVD clients in 40 countries worldwide and maintains a presence in the USA, Europe, Japan, China, Russia, Canada and Australia. Emergo Group was founded in 1997 and is headquartered in Austin, Texas.

Contact: Chris Schorre, Vice President of Global Marketing
US Telephone: +1.512.327.9997
Email: cs [at] emergogroup [dot] com
Website: http://www.EmergoGroup.com