Archive for the ‘Regulation’ Category
Monday, September 12th, 2011
Donawa Lifescience Consulting has scheduled a seminar on best practices for planning and conducting clinical studies on medical devices in Europe. The seminar will be held in Munich, Germany, on 7 November 2011.
Posted in Regulation, Seminars | Add Comment »
Monday, August 8th, 2011
The story that will not die—yes, the 510(k) report from the US Institute of Medicine—continued to dominate medtech coverage last week. An editorial in the StarTribune, a newspaper based in the Minneapolis-St. Paul area that, consequently, devotes significant editorial space to the medical industry, called the report an “unrealistic and ...
Posted in Business News, Regulation, medtechinsider | Add Comment »
Wednesday, August 3rd, 2011
Foreign medical device manufacturers registered in Japan that move their factories or change their corporate identity following a merger or acquisition are required to resubmit a request for accreditation as a foreign medical device manufacturer. Moreover, the companies are not allowed to export devices until they have received their reaccreditation. ...
Posted in Medtech World News: Update from Japan, Regulation | Add Comment »
Monday, August 1st, 2011
The week of July 25 ended with a whimper, as the Institute of Medicine issued its report on the “flawed” 510(k) process. US industry association AdvaMed dismissed the report as undeserving of “serious consideration,” but US FDA has opened a public docket and is inviting comments nonetheless. The DeviceTalk blog ...
Posted in Business News, Regulation, medtechinsider | Add Comment »
Monday, July 25th, 2011
Tension between US FDA and the medical device industry is rising, noted an article on IVD Technology last week. The article focused on a report published last week by US FDA's Center for Devices and Radiological Health. The report places most of the blame for the increased review time for ...
Posted in Regulation | Add Comment »
Wednesday, July 13th, 2011
COCIR, CEN and CENELEC will be holding the workshop "Regulating Medical Software" on 12 October 2011. The workshop will take place in the CEN-CENELEC Management Center in Brussels.
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Tuesday, July 12th, 2011
Curbing healthcare expenditures while ensuring access to quality care and encouraging innovation is one of the fundamental challenges of our time. How healthcare reforms in Europe and the United States address this challenge and the impact they will have on the medical technology industry is the subject of a report ...
Posted in Business News, Industry News, Regulation, medtechinsider | Add Comment »
Tuesday, June 21st, 2011
Guest post from Stewart Eisenhart, Emergo Group
Recent analysis of data available on the US FDA website shows that average 510(k) clearance times for medical device manufacturers have increased 37% between January 2006 and May 2010.
The study, conducted by medical device regulatory consultancy Emergo Group, found that the number of days ...
Posted in Regulation, US Regulatory | Add Comment »
Monday, June 6th, 2011
The Council of the European Union has emphasised the importance of medtech innovation in improving health outcomes and the sustainability of European healthcare systems, writes Eucomed in a press release issued today. European Member States also reaffirmed their support of the current legal framework, recommending focused attention to essential amendments ...
Posted in Regulation, medtechinsider | Add Comment »
Thursday, May 26th, 2011
Germany has become a global driver of medical technology innovation, according to experts attending a conference organised by German medtech association BVMed earlier this month. To the question posed by the conference title—Will Germany Take Over the Dynamics of Global Medical Technology?—attendees responded with a resounding, Ja!, according to a ...
Posted in Regulation, medtechinsider | Add Comment »
Wednesday, May 25th, 2011
Two-thirds of small medical device and diagnostic companies are obtaining clearance for new products in Europe first, according to a comprehensive industrywide survey about US FDA's 510(k) product review process by researchers at Northwestern University. According to the poll, which surveyed more than 350 professionals engaged in medical device development ...
Posted in Regulation, medtechinsider | 1 Comment »
Sunday, May 22nd, 2011
India’s medical device market is worth about US$3 billion and is ranked as the fourth largest medical device market in Asia, after Japan, China and South Korea. With a population of 1.2 billion people and a booming economy, there is increasing demand for medical devices, especially in the private healthcare ...
Posted in Medtech World News: Update from India, Regulation, medtechinsider | Add Comment »
