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Emergo Group expands services to China and Japan.

Increased interest by US manufacturers in Asian markets and recent regulatory changes prompted Emergo Group Inc. to expand its medical device regulatory consulting services to China and Japan.

The weak US dollar also played an important role in the company's decision, according to Emergo executives.

With its new office in Tokyo, Japan, the company now is able to help US medical device manufacturers with issues such as the Japanese Pharmaceutical Affairs Law, quality management system implementation, reimbursement, medical distributor search and independent Designated Marketing Authorization Holder (D-MAH) representation. The company's Japanese division recently was given a license from the Japanese Ministry of Health, Labor and Welfare to act as an official D-MAH in Japan.

Emergo officials said they decided to open an office in China after noticing increased demand in the country from clients. The company's Beijing office helps manufacturers achieve regulatory approval from the China State Food and Drug Administration (SFDA), and it acts as a regulatory liaison to the SFDA for manufacturers with no presence in the country.

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Title Annotation:INDUSTRY NEWS
Publication:Orthopedic Design & Technology
Article Type:Brief article
Date:Sep 1, 2008
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