Monday,
November 8th, 2004
Pacific Medical Systems Limited announced today it had received formal notification of regulatory approval in Japan, the world’s second biggest market for medical devices.
The Chief Executive of Pacific Medical Systems, Mr Jules Flach, said today, “We are very excited to have received this very important approval some 2 months ahead of the original schedule. Now that we have the formal approvals for the Japanese market, we can initiate our marketing plan. We will be working hand-in-hand with our dedicated distribution partner Cathex to ensure a high profile presence at all the relevant medical events, as well as providing in-hospital demonstrations of the USCOM equipment at key clinical sites throughout the country. Japan is an extremely important market and we are all very excited that we can now open the market up to USCOM.”
An approval certificate was received from the Japanese Ministry of Health, Labor and Welfare today.
Our Japan distribution partner, Cathex Company Limited is a leading player in the import and sale of medical devices and equipment. Headquartered in Tokyo, Cathex currently distributes ultrasound image diagnosis units, cardiac catheters, disposable catheters & tubes, mobile X-ray units and orthopaedic equipment.
Cathex placed orders for seven USCOM cardiac output devices in April 2004.
The company has been working closely with the Japanese Ministry in order to ensure the USCOM technology is fully compliant with the Japanese regulatory rules and guidelines.
In advance of regulatory approval, the USCOM system has also been on show at a number of medical exhibitions in Japan, providing potential customers with a sneak preview of the USCOM non-invasive technology.
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