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	<title>Singapore Health Sciences Authority &#8211; Eisner Safety Consultants</title>
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	<description>Regulatory &#38; Safety Experts for Global Medical Device Approvals</description>
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		<title>Draft ASEAN Medical Devices Directive (AMDD)</title>
		<link>https://eisnersafety.com/2012/08/17/draft-asean-medical-devices-directive-amdd/?utm_source=rss&#038;utm_medium=rss&#038;utm_campaign=draft-asean-medical-devices-directive-amdd</link>
		
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		<pubDate>Fri, 17 Aug 2012 20:02:58 +0000</pubDate>
				<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[AMDD]]></category>
		<category><![CDATA[ASEAN]]></category>
		<category><![CDATA[ASEAN AMDD]]></category>
		<category><![CDATA[association of southeast asian nations]]></category>
		<category><![CDATA[health sciences authority]]></category>
		<category><![CDATA[HSA]]></category>
		<category><![CDATA[industry consultation]]></category>
		<category><![CDATA[Medical]]></category>
		<category><![CDATA[Medical Device]]></category>
		<category><![CDATA[Medical Device Industry]]></category>
		<category><![CDATA[Medical Device Regulatory]]></category>
		<category><![CDATA[Medical Devices]]></category>
		<category><![CDATA[medical devices directive]]></category>
		<category><![CDATA[Singapore]]></category>
		<category><![CDATA[Singapore Health Sciences Authority]]></category>
		<category><![CDATA[Singapore HSA]]></category>
		<category><![CDATA[southeast asian nations]]></category>
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					<description><![CDATA[Consultation on AMDD &#8220;From the Singapore Health Sciences Authority &#8211; Updated 2 August 2012 &#8211; As part of efforts to enhance economic integration among ASEAN (Association of Southeast Asian Nations) member states, ASEAN has been working on developing a standardised framework]]></description>
										<content:encoded><![CDATA[<h3><span style="font-family: arial, helvetica, sans-serif; font-size: small;">Consultation on AMDD</span></h3>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">&#8220;From the Singapore Health Sciences Authority &#8211; Updated 2 August 2012 &#8211; As part of efforts to enhance economic integration among <a href="http://www.aseansec.org/" target="_blank" rel="noopener noreferrer">ASEAN (Association of Southeast Asian Nations)</a> member states, ASEAN has been working on developing a standardised framework for regulating medical devices that is <span style="text-decoration: underline;"><strong>targeted for implementation by December 2014</strong></span>. <span id="more-2651"></span> </span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">This draft set of broad principles is called the ASEAN Medical Devices Directive (AMDD), and it is now ready for industry consultation. This published AMDD is <strong><span style="text-decoration: underline;">not the final version</span></strong>, and there may be changes depending on feedback received from you and other interested parties.</span></p>
<p><span style="font-family: arial, helvetica, sans-serif; font-size: small;">We would like to invite you to provide your feedback on AMDD using this form and send it to <a href="mailto:&#72;S&#65;_M&#68;_&#81;&#117;e&#114;&#121;&#64;hs&#97;.&#103;ov&#46;s&#103;"><span style="color: #0000ff;">HS&#65;&#95;MD_Qu&#101;r&#121;&#64;hsa.go&#118;.&#115;g</span></a> by <strong><span style="text-decoration: underline;">31 August 2012</span></strong>. We regret to inform you that we are unable to include any comments received after the deadline for consideration due to time constraints.&#8221;</span></p>
<p><a href="http://www.eisnersafety.com/wp-content/uploads/2012/08/Template-for-Comments-to-AMDD-due-31-Aug-2012.doc">Template for Comments to AMDD due 31 Aug 2012</a></p>
<p><a href="http://www.eisnersafety.com/wp-content/uploads/2012/08/AMDD-Draft-for-consultation-02-Aug-2012.pdf">AMDD &#8211; Draft for consultation &#8211; 02 Aug 2012</a></p>
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