Emergo Group Releases New Charts Explaining Medical Device Approval Process in 10 Countries

March 26, 2010 - PRLog -- AUSTIN, Texas – Medical device consultancy Emergo Group Inc. has released ten new color flow charts that clearly explain the regulatory approval process for medical device manufacturers interested in marketing their products in Australia, Brazil, Canada, China, Europe, Japan, Mexico, Russia, South Korea or the United States.

Chris Schorre, VP of Global Marketing for Emergo Group, notes: “We created these charts because so many of our clients wanted a high level overview of the medical device registration process in a specific country. Rather than create lengthy verbal explanations of the processes, we created these visual flow diagrams to help medical device manufacturers more easily understand the basic steps to approval and the order in which they happen.”

According to Emergo Group, each chart provides an easy-to-understand overview of applicable medical device regulations, governing entities, quality system compliance, registration dossiers, labeling/clinical/testing requirements and validity of approval certificates.  Flow charts for the following countries are available for open download in PDF format at EmergoGroup.com/literature:

AUSTRALIA, BRAZIL, CANADA, CHINA, EUROPE, JAPAN, MEXICO, RUSSIA, SOUTH KOREA, USA   Charts available here:  http://www.emergogroup.com/literature

Schorre adds that Emergo Group is also developing Flash-based presentations explaining the approval process in these countries, much like their popular 11 minute YouTube video explaining the European CE Marking process for medical devices (http://www.youtube.com/watch?v=-P57YoO9E4I).  These videos will be released over the next several months.



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Emergo Group is an international medical device consulting firm that helps companies with regulatory compliance/approvals and distributor qualification in markets worldwide, with offices in the USA, Canada, Mexico, Europe, China, Japan and Australia.