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	<title>QA/RA Updates for Medical Device Professionals</title>
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	<description>International Quality and Regulatory Compliance Updates for the Medical Device Industry</description>
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		<title>PMDA Issues List of Pre-Market Certificates Issued by RCBs in Japan</title>
		<link>http://www.qara.info/regulatory/pmda-rcb-certificates-issued/</link>
		<comments>http://www.qara.info/regulatory/pmda-rcb-certificates-issued/#comments</comments>
		<pubDate>Wed, 27 Jan 2010 21:48:03 +0000</pubDate>
		<dc:creator>Sage Farrar, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>

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		<description><![CDATA[The PMDA has just recently released a spreadsheet enumerating the pre-market certificates issued by each of the 12 Registered Certification Bodies (RCBs) sanctioned under the Pharmaceutical Affairs Law (PAL), Article 23. This release was in response to a request from the Ministry of Health, Labor, and Welfare (MHLW) to improve the transparency of the agency. 
The [...]]]></description>
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		<title>House Increases FDA Funding for Medical Devices</title>
		<link>http://www.qara.info/regulatory/house-furthers-fda-funding-for-medical-devices/</link>
		<comments>http://www.qara.info/regulatory/house-furthers-fda-funding-for-medical-devices/#comments</comments>
		<pubDate>Fri, 09 Oct 2009 21:16:06 +0000</pubDate>
		<dc:creator>Sage Farrar, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>

		<guid isPermaLink="false">http://www.qara.info/?p=89</guid>
		<description><![CDATA[The US House of Representatives has passed a bill that will increase funding for the FDA’s Center for Devices and Radiological Health (CDRH), to US$315M in fiscal year 2010. Industry exponents and lobbyists have praised the efforts for the advancement of the device industry, but the increase falls below the $350M originally sought. Still, the [...]]]></description>
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		<title>Faster medical device approval times in Japan may be in store</title>
		<link>http://www.qara.info/regulatory/faster-medical-device-approval-times-in-japan-may-be-in-store/</link>
		<comments>http://www.qara.info/regulatory/faster-medical-device-approval-times-in-japan-may-be-in-store/#comments</comments>
		<pubDate>Thu, 08 Oct 2009 19:16:59 +0000</pubDate>
		<dc:creator>Sage Farrar, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>

		<guid isPermaLink="false">http://www.qara.info/?p=86</guid>
		<description><![CDATA[As part of Japan’s Five Year Action Plan, Japan has set goals for specific in-house improvements to ease the process of obtaining clearance from the Pharmaceuticals and Medical Devices Agency (PMDA) and reduce lengthy review times. The PMDA hopes to more than double their review staff by 2013 and is establishing three distinct review divisions [...]]]></description>
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		<title>FDA Hosts Public Hearing to Address the Internet and Social Media and how they Relate to Product Regulation</title>
		<link>http://www.qara.info/regulatory/fda-hosts-public-hearing-to-address-the-internet-and-social-media-and-how-they-relate-to-product-regulation/</link>
		<comments>http://www.qara.info/regulatory/fda-hosts-public-hearing-to-address-the-internet-and-social-media-and-how-they-relate-to-product-regulation/#comments</comments>
		<pubDate>Wed, 23 Sep 2009 16:06:46 +0000</pubDate>
		<dc:creator>Sage Farrar, Emergo Group</dc:creator>
				<category><![CDATA[Regulatory Affairs]]></category>
		<category><![CDATA[FDA]]></category>

		<guid isPermaLink="false">http://www.qara.info/?p=75</guid>
		<description><![CDATA[The FDA is holding a public hearing on November 12 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public [...]]]></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>

		<guid isPermaLink="false">http://www.qara.info/?p=70</guid>
		<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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		<slash:comments>0</slash:comments>
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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>

		<guid isPermaLink="false">http://www.qara.info/?p=68</guid>
		<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>

		<guid isPermaLink="false">http://www.qara.info/?p=65</guid>
		<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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		<slash:comments>0</slash:comments>
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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>

		<guid isPermaLink="false">http://www.qara.info/?p=62</guid>
		<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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