Medical Devices Today

Manufacturers Negotiate With Japan For Higher User Fees To Speed Review

Full article reprinted from PharmAsia News - July 15, 2008

U.S. industry has long complained that Japan's pre-market medical device review process is filled with inefficiencies and unreasonable requests. By April 1 of next year the number of medical device reviewers in Japan could increase dramatically via a substantial raise in industry-paid user fees. Find out why?

The Art Of Selecting Outsourcing Partners In China

Insider Analysis Report from PharmAsia News   - June 30, 2008

Medical device manufacturers doing business in China, are carefully watching the the multinational pharmaceutical manufacturers already doing business in the region. Find out what lessons they are learning in this special report.

India Strives To Create Regulatory Body For Devices With Help From Industry

Full article reprinted from PharmAsia News - July 15, 2008

The government of India is accepting input from manufacturers to help it develop a new medical device regulatory body, following a 2006 mandate to register certain medical devices.

Japan Device Maker Terumo To Boost Catheter Production In U.S., Europe, Vietnam

Full article reprinted from PharmAsia News - July 7, 2008

TOKYO - Seeing little growth prospect in Japan's rapidly aging population, leading medical device maker Terumo Corp. will boost its catheter production at plants in Maryland, Belgium, Vietnam and Japan as part of its new mid-term business plan, a company spokesman said July 4.

While Navigating Risks, WuXi To Benefit from Global Outsourcing

Full article reprinted from PharmAsia News - July 7, 2008

BEIJING - WuXi PharmaTech is positioning itself to ride the rising tides of global pharmaceutical outsourcing to strengthen its role as China's largest contract research organization, according to a WuXi executive and an independent analyst.

Japan Stimulus Program Focuses On Device Approval Lag, R&D Cooperation With Asia

Full article reprinted from PharmAsia News - July 1, 2008

TOKYO - Japanese Prime Minister Yasuo Fukuda's cabinet June 27 approved the fiscal 2008 economy stimulus package that in part featured accelerating approval of Japanese-manufactured and imported pharmaceutical products and medical devices and government support for developing innovative technologies.

Eisai Transfers Medical Device Subsidiary To Terumo

Full brief reprinted from PharmAsia News - June 26, 2008

Eisai announced June 19 that the company signed an agreement with Terumo to transfer all shares of Clinical Supply, a Eisai subsidiary that manufactures and markets medical devices such as catheters. Within 30 days, Eisai will transfer 84.8 percent of Clinical Supply shares to Terumo, which is strengthening its catheter business. No details on the deal's price were disclosed. (Click here for more - Japanese language)

"Eisai Transfers Medical Device Subsidiary Shares To Terumo" - Jiji Press News (6/19/08)

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Indian Semiconductor Makers See Medical Device Opportunities

Full summary reprinted from PharmAsia News - June 19, 2008

Find out why Indian semiconductor manufacturers are eyeing the medical device sector.

WuXi PharmaTech Set For Sales Synergy with U.S. Subsidiary AppTec

Full article reprinted from PharmAsia News - June 9, 2008

BEIJING - WuXi PharmaTech, one of China's fastest-growing contract research organizations in the pharmaceutical and medical device sectors, is laying the groundwork to boost earnings through cross-selling synergies with its recently acquired U.S.-based biologics firm AppTec Laboratory Services.

AGA Medical Reaches Settlement With Justice Dept. Over Bribes In China

Full article reprinted from "The Gray Sheet" - June 9, 2008

AGA Medical, a private firm that makes patent foramen ovale closure devices, agreed June 3 to immediately pay a $2 million criminal penalty under the Foreign Corrupt Practices Act (FCPA) and enter into a deferred prosecution agreement with the U.S. Department of Justice in connection with payments the company made to doctors in China.