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Medical e-News Round-Up - Issue 19

This issue covers:

Japan’s medical device market improves

Japan’s med-tech market is showing signs of improvement following efforts by the regulatory body to reduce product approval lag times and the government’s targeting of the industry as a key growth sector.

A report in the trade journal European Medical Device Technology claims that Japan’s ageing population could benefit foreign companies, in particular. According to the Ministry of Health, Labour and Welfare, all artificial cardiac valves (worth €141 million), 99.6% of artificial hearts (€256 million), 98.4% of artificial respirators (€376 million) and 81.4% of contact lenses (€1.6 billion) sold in Japan are manufactured abroad.

Overall Japan accounts for 10% of the total global market for medical devices, and ranks as the third largest after the United States and the European Union. It is reported that high-end medical technology from the United States and Europe continues to be in great demand.

Historically, Japan’s rigid regulatory system has been a barrier to entry, but the government now appears to be more receptive to streamlining the product approval process and encouraging innovation. For example, the Ministry of Health, Labour and Welfare has more than doubled the number of reviewers at the Pharmaceuticals and Medical Devices Agency (PMDA) in the past three years. More at www.emdt.co.uk 


Optical company sees the benefits of Uni-Therm

Field engineers at Olympus KeyMed Ltd have turned to Rigel Medical’s Uni-Therm analyser for improved in-service performance testing of its electrosurgical devices. These items of equipment use electricity to produce enough heat to enable surgeons to cut body tissue or seal bleeding vessels during operations. 

Twenty Uni-Therm units have been specified to allow automation of the performance testing of Olympus’s electrosurgical equipment, resulting in greater efficiencies. Already, the new testers have enabled engineers working at sites across the UK to accurately measure the performance of each device and complete high frequency leakage, high current, power distribution and patient return plate alarm testing.

Compliant with IEC 60601, the high performance Uni-Therm is capable of verifying and calibrating the electrosurgical equipment while guiding the engineer through all test procedures automatically and most of all safe.

Olympus is a leading manufacturer of advanced optical and digital equipment for the healthcare and consumer electronics sectors, leading the way in designing endoscopy and microscopy products among others.

Martin Wallace, head of field service at the Southend-on-Sea based company, said: “Rigel supplies us with a range of high performance, high quality instruments, which provide the engineers with convenient, easy-to-use and accurate testing solutions.

“The Uni-Therm incorporates an excellent range of features for a tester of its size, while the added value benefits, like improved connectivity and ease-of-use, are particularly impressive.

“The ability to import and export data is also a particularly beneficial feature, enabling us to store test information which can then be easily retrieved and used for quality control purposes at a later date.”


Senators push to repeal U.S. medical device tax

A group of U.S. senators have introduced legislation to try to repeal a tax on medical devices, which is part of President Barack Obama´s controversial new healthcare reforms.

The tax applies to a range of medical products - everything from bedpans and surgical tools to the expensive heart devices produced in the home states of the senators backing the repeal. It is among several new industry levies in Obama´s 2010 healthcare overhaul law, which aims to provide health insurance for the tens of millions of Americans who currently do not have any cover.

The 2.3% has already come into effect and is projected to raise about $30 billion over a decade to fund extended coverage. Senators from Minnesota, Indiana and Pennsylvania, where many big medical technology companies are based, are among those who have been pushing for the tax repeal.

"In order to compete in the global economy our medical device businesses need a level playing field," said Democratic Senator Amy Klobuchar of Minnesota, home to Medtronic Inc, one of the biggest medical device makers.

Although dozens of industry officials and supportive lawmakers say the tax will hurt innovation and job creation, the law is already being implemented and was declared constitutional by the U.S. Supreme Court last year. That and the cost of repeal - depriving the federal government of billions at a time of dire fiscal straits - suggest the measure to kill the tax is unlikely to win approval.


Russian medical device regulations planned for 2013 

Changes to how medical devices are regulated in the Russian Federation are planned for early 2013 but final implementation of the new rules remains tentative, according to medical device consultants Emergo Group.

The Russian Ministry of Health has already approved new orders regarding medical device classification, importation and adverse event handling but now under consideration are medical device vigilance processes, conformity assessments as well as quality and safety issues.

All orders under consideration must be approved before authorities begin implementing actual regulations. Some of the most important changes that may occur include a less direct regulatory role for public healthcare watchdog Roszdravnadsor - final approval will be made by ‘expert reviewers’ rather than the regulator itself. The move may also see a lack of timelines for medical testing, meaning the whole process could last for years, and inclusion of medical device registration fees written into law.

However, exact implementation timeframes for the new regulations are not yet clear according to the Emergo Group, which is providing regular updates about the regulatory developments as they come into force across Russia. Find out more at www.emergogroup.com


Make a date with Rigel

Rigel Medical will be exhibiting at a number of events and shows in 2013 including MD Expo (2-4 April 2013, Washington DC, USA); EBME Associates 2013 Seminar (1st May 2013, Milton Keynes, UK); Wümek – Euritim (May 13-14, 2013, Würzburg, Germany); AAMI (June 1-3, 2013, Long Beach, CA, USA); and MEDICA (November 20 – 23, 2013, Dusseldorf, Germany).

We look forward to seeing you at these and other events throughout the year where you can see all our products and talk to the experts; so make sure you have all the details and keep abreast of the latest news by visiting our website www.rigelmedical.com/events

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