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	<title>QA/RA Updates for Medical Device Professionals &#187; Chris Schorre, Emergo Group</title>
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	<description>International Quality and Regulatory Compliance Updates for the Medical Device Industry</description>
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		<title>Health Canada to require STED format for Class 3/4 medical device submissions</title>
		<link>http://www.qara.info/regulatory/health-canada-to-require-sted-format-for-class-34-medical-device-submissions/</link>
		<comments>http://www.qara.info/regulatory/health-canada-to-require-sted-format-for-class-34-medical-device-submissions/#comments</comments>
		<pubDate>Thu, 13 Aug 2009 16:34:26 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[Health Canada]]></category>
		<category><![CDATA[STED]]></category>

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		<description><![CDATA[Health Canada just put out an official notice that they are going to require the STED format for most Class 3 and Class 4 medical device license submissions by July 2010. The agency says it will &#8220;most likely occur in a phased in approach&#8221; and is expected to be fully implemented by July 1, 2010. [...]]]></description>
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		<title>MHRA publishes updated guidance document for clinicals conducted in UK</title>
		<link>http://www.qara.info/regulatory/uk-mhra-publishes-clinical-trial-guidance/</link>
		<comments>http://www.qara.info/regulatory/uk-mhra-publishes-clinical-trial-guidance/#comments</comments>
		<pubDate>Wed, 12 Aug 2009 19:43:15 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[clinical]]></category>
		<category><![CDATA[MHRA]]></category>
		<category><![CDATA[UK]]></category>

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		<description><![CDATA[In July, the MHRA issued an updated guidance document on clinical investigations to be carried out in the UK. It’s an update on previously available guidance that takes into account the impact of 2007/47/EC, the revision to the directives which takes effect in March 2010. One of the major updates in this document is the confirmation [...]]]></description>
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		<title>Redesigned US FDA website an improvement</title>
		<link>http://www.qara.info/regulatory/redesigned-us-fda-website-an-improvement/</link>
		<comments>http://www.qara.info/regulatory/redesigned-us-fda-website-an-improvement/#comments</comments>
		<pubDate>Thu, 25 Jun 2009 21:17:06 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>

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		<description><![CDATA[The US FDA recently launched a new website, with a new look and organization. It is certainly better than the old site, but it still could use some improvement in the way information for consumers versus industry is presented. In any case, check out the medical devices section of the new FDA site for yourself . Also see [...]]]></description>
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		<title>European Commission issues important guidance document on 2007/47/EC</title>
		<link>http://www.qara.info/regulatory/guidance-document-2007-47-ec/</link>
		<comments>http://www.qara.info/regulatory/guidance-document-2007-47-ec/#comments</comments>
		<pubDate>Thu, 11 Jun 2009 16:37:03 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[2007/47/EC]]></category>
		<category><![CDATA[93/42/EEC]]></category>

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		<description><![CDATA[The EU has just released an important guidance document that should be read by every company selling medical devices in Europe. It provides guidance on an amendment to the original Medical Devices and Active Implantable Medical Devices Directives. Probably the most important part of the 2007/47/EC guidance for medical device companies is that the amended [...]]]></description>
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		<title>US FDA may get large increase in funding</title>
		<link>http://www.qara.info/regulatory/us-fda-may-get-large-increase-in-funding/</link>
		<comments>http://www.qara.info/regulatory/us-fda-may-get-large-increase-in-funding/#comments</comments>
		<pubDate>Fri, 08 May 2009 16:07:46 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[FDA]]></category>

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		<description><![CDATA[Today the Wall Street Journal published an article noting that President Obama has requested an additional $300,000,000 in funding for the US FDA, from $2.06 billion to $2.35 billion. That&#8217;s a 14% increase.  If the funding is approved by Congress, the agency will likely hire more inspectors which will lead to more frequent visits from the FDA [...]]]></description>
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		<title>US FDA announces new website</title>
		<link>http://www.qara.info/regulatory/us-fda-announces-new-website/</link>
		<comments>http://www.qara.info/regulatory/us-fda-announces-new-website/#comments</comments>
		<pubDate>Fri, 01 May 2009 22:00:35 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[FDA]]></category>

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		<description><![CDATA[The Food and Drug Administration has said that it plans to launch a redesigned website, presumably in 2009. This should be good news for users of the site. Hopefully, guidance documents and other relevant information will be easier to find, and databases will be easier to use. Here&#8217;s the brief announcement. Keep your fingers crossed. [...]]]></description>
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		<title>US FDA issues notice on preamendment Class III devices</title>
		<link>http://www.qara.info/regulatory/us-fda-issues-notice-on-preamendment-class-iii-devices/</link>
		<comments>http://www.qara.info/regulatory/us-fda-issues-notice-on-preamendment-class-iii-devices/#comments</comments>
		<pubDate>Thu, 09 Apr 2009 23:02:09 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[FDA]]></category>

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		<description><![CDATA[The Food and Drug Administration (FDA) just posted a notice in the April 9, 2009 Federal Register notifying manufacturers of 25 types of Class III medical devices that their products will be subject to scrutiny soon. The 25 products are all &#8220;preamendment&#8221; Class III devices that were already being sold on the US market prior to [...]]]></description>
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		<title>Updated list of recognized Standards published by US FDA</title>
		<link>http://www.qara.info/regulatory/updated-list-of-concensus-standards-published-by-us-fda/</link>
		<comments>http://www.qara.info/regulatory/updated-list-of-concensus-standards-published-by-us-fda/#comments</comments>
		<pubDate>Thu, 19 Mar 2009 15:41:19 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[CDRH]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[standards]]></category>

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		<description><![CDATA[The Center for Devices and Radiological Health (CDRH) within the US Food and Drug Administration has published an updated list of recognized standards used in premarket reviews of medical device submissions. This list is generally updated every 3-6 months by FDA. You can download the most recent list published in the Federal Register.
]]></description>
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		<slash:comments>0</slash:comments>
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		<title>New requirements for electrical medical devices sold into Ontario, Canada</title>
		<link>http://www.qara.info/regulatory/new-requirements-for-electrical-medical-devices-sold-into-ontario-canada/</link>
		<comments>http://www.qara.info/regulatory/new-requirements-for-electrical-medical-devices-sold-into-ontario-canada/#comments</comments>
		<pubDate>Fri, 13 Mar 2009 20:45:48 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[60601]]></category>
		<category><![CDATA[canada]]></category>

		<guid isPermaLink="false">http://www.qara.info/?p=52</guid>
		<description><![CDATA[Effective April 1, 2009 manufacturers of electrical medical devices and manufacturers of electrical components that are to be sold into the Province of Ontario are required to register with the Ontario Electrical Safety Authority. Companies will have from April 1 to August 30, 2009 to comply with this new registration requirement. You can read more [...]]]></description>
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		<title>Resource for overview of medical device regs</title>
		<link>http://www.qara.info/regulatory/resource-for-overview-of-medical-device-regs/</link>
		<comments>http://www.qara.info/regulatory/resource-for-overview-of-medical-device-regs/#comments</comments>
		<pubDate>Fri, 13 Mar 2009 20:20:21 +0000</pubDate>
		<dc:creator>Chris Schorre, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[DOC]]></category>
		<category><![CDATA[regulations]]></category>

		<guid isPermaLink="false">http://www.qara.info/?p=50</guid>
		<description><![CDATA[A lot of people know that the US Department of Commerce publishes short research reports on the medical device industry in specific countries, but it&#8217;s worth repeating in case you have not visited in some time. You can read regulatory process overviews on 20+ countries at the DOC website. If you want to read the [...]]]></description>
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