Archive for the ‘Regulation’ Category
Wednesday, May 16th, 2012
The Irish Medical Devices Association (IMDA) last week announced its support for the EU stability treaty, saying that it's necessary to help Ireland's exporters continue driving economic growth. Ireland will vote to ratify the treaty, officially titled the "Treaty on Stability, Cooperation and Governance in the Economic and Monetary Union," ...
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Tuesday, May 15th, 2012
The UK Health Minister Lord Howe has published a report looking into the actions of the Medicines and Healthcare Products Regulatory Authority (MHRA) relating to the Poly Implant Prothèse (Pip) implant scandal.
The report found that the agency started to receive reports related to the Pip implant scandal as early as ...
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Friday, April 27th, 2012
The Pip resolution, drafted by the Environment and Public Health (ENVI) Committee of the European Parliament and unanimously passed on 25 April, is a mixed bag, according to Eucomed. The pan-European association applauds many of the measures, including greater oversight of Notified Bodies, more robust vigilance reporting, the introduction of unannounced ...
Posted in EU Regulatory, Regulation, medtechinsider | 2 Comments »
Tuesday, April 3rd, 2012
Cranfield University will hold a short course on medical technology regulatory affairs and compliance on 12–14 June 2012. The course is designed to provide an understanding of the role of the medical technology regulatory affairs professional and is titled "Management of Regulatory Affairs & its Contribution to the Medical Technology ...
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Tuesday, March 20th, 2012
The Health and Social Care bill, a controversial bill that will restructure the UK National Health Services (NHS), was passed today by the UK government. The bill, designed to decrease bureaucracy and administration costs, will dramatically reform NHS by introducing more competition and reducing central government control.
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Friday, March 2nd, 2012
Mr. Yin Li officially took over as the new chief of the State Food and Drug Administration (SFDA) on 20 February 2012, replacing Mr. Shao Ming who had reached retirement age. Shao Ming's replacement had been a source of speculation since late 2011.
The position was not especially sought after by deputy directors ...
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Monday, February 20th, 2012
Last week, the European Commission held a Medical Devices Expert Group (MDEG) meeting on the upcoming revision of the Medical Devices Directives, according to Eucomed. Another meeting was held on 6 February. At the meetings, Eucomed voiced its position on the draft revision. BD Diagnostics announced the acquisition of Kiestra ...
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Monday, February 13th, 2012
Last week, MHRA announced that Eucomed's former Chief Executive has joined the agency as Director of Medical Devices. European Health Commissioner John Dalli said he is very concerned about the impact the faulty silicone breast implants by Poly Implant Prothese will have on the health of women and announced that ...
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Thursday, February 9th, 2012
A French law enacted on 29 December 2011 that impacts the healthcare industry "foreshadows a revolution in behaviour, attitudes and the overall public health landscape," write consultants Anne Catherine Maillois-Perroy and Yves Th Tillet in an article published in Regulatory Focus (access is restricted to members of regulatory association RAPS. And as ...
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Friday, February 3rd, 2012
UBM Canon's medical content team has announced a new project focused on the upcoming US election and its impact on the medtech industry. The project is called Medtech Issues in an Election Year and includes a dedicated page on the MD+DI website, e-newsletters and a webcast series. The MD+DI page, ...
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Monday, January 30th, 2012
Last week, US President Barack Obama presented a blueprint for reshoring—bringing manufacturing back to the United States—in his State of the Union Address. Obama proposed tax breaks and financial incentives for American companies that bring back jobs to the United States. It remains to be seen if these ideas get ...
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Friday, January 27th, 2012
Over the years, a growing number of medical device companies in the United States have decided to obtain the CE mark for new products before attempting to approve products through FDA. While FDA is not monolithic, many in the industry view the European system as generally more consistent, transparent, and ...
Posted in Regulation, medtechinsider | 3 Comments »
