Archive for the ‘Regulation’ Category
Friday, January 27th, 2012
Nick Woods, Director of Hill Woods Medical Media Ltd, has written an editorial for MD+DI. In it, Woods explains that US manufacturers aren’t really arguing the right way to get the device tax repealed.
“The only problem is, chaps, that the legislature is either not listening or it doesn’t believe you. ...
Posted in Regulation | 1 Comment »
Thursday, January 26th, 2012
Russia is expected to release new medical device regulations within the next few weeks, writes Stewart Eisenhart, an editor covering regulatory affairs for Emergo Group, in a blog post on the Massdevice website. Eisenhart expects the regulations to be clearer and have more specific requirements than current regulations, for example ...
Posted in Regulation | Add Comment »
Tuesday, January 24th, 2012
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has entered into a collaboration with Gifu University to promote education and research involving medical technology. Under the agreement, students at Gifu University’s United Graduate School of Drug Discovery and Medical Information Sciences can attend classes taught by PMDA staff and have an ...
Posted in Industry News, Japan, Medtech World News: Update from Japan, Regulation | Add Comment »
Wednesday, December 21st, 2011
An upcoming short course offered at Cranfield University (Bedford, UK) is designed to explain the clinical trial process to regulatory affairs professionals. The course, Clinical Evaluation of Medical Technology, will take place from 13–15 March 2012. The focus of the course is clinical trials in relation to product development and ...
Posted in Regulation | Add Comment »
Thursday, December 8th, 2011
Eight pan-European industry associations have joined together to issue a position paper on industry involvement in health technology assessments (HTAs). The paper, which outlines the many benefits that industry can bring to the HTA process, was presented at the EUnetHTA Joint Action Conference in Gdansk on 8 December. Participants include ...
Posted in Regulation, medtechinsider | Add Comment »
Wednesday, November 30th, 2011
China passed its first patent law way back in . . . 1984! Clearly, protection of intellectual property does not have a long tradition in China, but like so many things in this amazing land, IP policy has evolved in dramatic fashion over a very short period of time. A ...
Posted in China, Regulation, medtechinsider | Add Comment »
Tuesday, November 29th, 2011
A new regulatory tool for medical device companies, the e-Zassi software, is now live on the Qmed website. Qmed, a UBM Canon site, is a qualified medical device supplier directory, search engine and industry resource. E-Zassi is an Innovation Management software platform for the medical device industry.
Part of the tool, ...
Posted in Regulation | Add Comment »
Thursday, November 24th, 2011
Eucomed, the European medical technology industry, has published a position paper with proposals for shaping a renewed legislative framework for medical devices in Europe. According to a press release issued by Eucomed today, the industry recognises the need to modernise and strengthen the current medical devices legislation in Europe and ...
Posted in Regulation | Add Comment »
Tuesday, November 22nd, 2011
EMDT's conference Managing Regulatory Change for Medical Devices will take place next week, 30 November-1 December at the Westin Grand in Berlin. The conference will offer practical solutions for how to identify, navigate and implement regulatory requirements.
Posted in EU Regulatory, Regulation, medtechinsider | Add Comment »
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 »
