Archive for the ‘Regulation’ Category
Sunday, October 23rd, 2011
The Medical Technologies Evaluation Programme at the UK National Institute for Health and Clinical Excellence (NICE) welcomed the appointment last week of a new external assessment centre. The centre will provide NICE with independent assessment of the evidence for medical technologies and related economic analysis. It will also play a ...
Posted in Regulation, Research, medtechinsider | Add Comment »
Monday, October 3rd, 2011
EMDT has announced the launch of a new conference titled "Managing Regulatory Change for Medical Devices," a conference providing practical guidance to help senior executives navigate through the uncertainty of medical device regulation in Europe, the United States and emerging markets. The conference will take place on 30 November–1 December ...
Posted in Conferences, Regulation, medtechinsider | Add Comment »
Wednesday, September 28th, 2011
The work of Notified Bodies (“NBs”) in the conformity assessment and certification of medical devices is a key cornerstone of the EU legislative system to safeguard public health. Established in the early 1990s to replace the nationally existing systems in the European member states, the legal framework follows the principles ...
Posted in Regulation | Add Comment »
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 ...
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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 ...
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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 »
