09/17/2008

Emergo Group, Inc.

Emergo Group opens new offices in Tokyo and Beijing

medical device regulatory consultants
Emergo group opens new asian offices, helps medical device manufacturers access Chinese and Japanese markets; Contact: Chris Schorre, Director of Marketing Online: www.EmergoGroup.com

Tokyo and Beijing -- Recent regulatory changes and an “export-friendly” exchange rate for US manufacturers have led Emergo Group to expand its medical device regulatory consulting services to China and Japan. These offices are in addition to existing offices in the US, Europe, Canada and Australia.

CEO Rene van de Zande says: “We have seen a significant increase in medical device companies that are searching for new sales opportunities beyond the North American and European markets. Part of the increased interest in Asian markets is due to a slowing US economy but manufacturers are also recognizing that a weak US dollar makes it easier for them to compete in markets such as China and Japan."

FIRM HELPS GUIDE COMPANIES THROUGH COMPLEX JAPANESE APPROVAL PROCESS.

Through Emergo’s new office in Tokyo, the company can now help medical device manufacturers access the third largest medical device market in the world. The company offers assistance with Japanese Pharmaceutical Affairs Law (JPAL), quality management system implementation, reimbursement, medical distributor search and independent Designated Marketing Authorization Holder (D-MAH) representation.

Emergo Japan K.K., a division of US-based Emergo Group, Inc., was recently awarded a license from the Japanese Ministry of Health, Labour and Welfare (MHLW) to act as an official D-MAH in Japan.

HELPING DEVICE COMPANIES COMPETE IN THE CHINESE MARKETPLACE.

Chief Operating Officer Michael van der Woude notes “Despite a lingering perception among Western companies that they cannot compete in China, high quality US medical devices are in high demand there. It’s hard to ignore the potential of the market.”

Increased demand from Emergo Group’s current client base of 500 medical device companies led to their decision to establish a presence in Beijing. The company can now assist manufacturers seeking regulatory approval from the China State Food and Drug Administration (SFDA). Emergo can also act as a Legal Agent and After Sales Agent, a mandatory regulatory liaison to the SFDA for manufacturers with no presence in the country.

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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 maintains offices in the USA, Canada, Europe, China, Japan and Australia and assists manufacturers in all of these markets. Emergo Group was founded in 1997 and is headquartered in Austin, Texas.