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<TITLE>의료기기법</TITLE>
<SUBJECT>제개정문</SUBJECT>
<AUTHOR>법제처 국가법령정보센터</AUTHOR>
<DATE></DATE> 
<KEYWORDS>법제처 국가법령정보센터</KEYWORDS>
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{국가법령이미지로고목록}
{이미지파일목록}
{QR코드이미지파일목록}
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<BOTTOMBORDER Type="Solid" Width="0.12mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.12mm" Color="0"/>
</BORDERFILL>
<BORDERFILL Id="28" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<RIGHTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<TOPBORDER Type="Solid" Width="0.4mm" Color="0"/>
<BOTTOMBORDER Type="Solid" Width="0.12mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.12mm" Color="0"/>
<FILLBRUSH><WINDOWBRUSH FaceColor="15198183" HatchColor="0"/>
</FILLBRUSH>
</BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="29" Shadow="false" Slash="0" ThreeD="false">
						<LEFTBORDER Type="Solid" Width="0.12mm"/>
						<RIGHTBORDER Type="Solid" Width="0.12mm"/>
						<TOPBORDER Type="Solid" Width="0.3mm"/>
						<BOTTOMBORDER Type="Solid" Width="0.12mm"/>
						<DIAGONAL Type="Solid" Width="0.12mm"/>
						<FILLBRUSH>
							<WINDOWBRUSH Alpha="0" FaceColor="14079702" HatchColor="0"/>
						</FILLBRUSH>
					</BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="30" Shadow="false" Slash="0" ThreeD="false">
						<LEFTBORDER Type="Solid" Width="0.12mm"/>
						<RIGHTBORDER Type="Solid" Width="0.12mm"/>
						<TOPBORDER Type="Solid" Width="0.12mm"/>
						<BOTTOMBORDER Type="Solid" Width="0.3mm"/>
						<DIAGONAL Type="Solid" Width="0.12mm"/>
					</BORDERFILL>
<BORDERFILL Id="31" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<RIGHTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<TOPBORDER Type="Solid" Width="0.12mm" Color="0"/>
<BOTTOMBORDER Type="Solid" Width="0.4mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.12mm" Color="0"/>
</BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="32" Shadow="false" Slash="0" ThreeD="false"><LEFTBORDER Type="Solid" Width="0.12mm"/><RIGHTBORDER Type="Solid" Width="0.12mm"/><TOPBORDER Type="None" Width="0.12mm"/><BOTTOMBORDER Type="None" Width="0.12mm"/><DIAGONAL Type="Solid" Width="0.12mm"/></BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="33" Shadow="false" Slash="0" ThreeD="false"><LEFTBORDER Type="Solid" Width="0.12mm"/><RIGHTBORDER Type="Solid" Width="0.12mm"/><TOPBORDER Type="Solid" Width="0.12mm"/><BOTTOMBORDER Type="None" Width="0.12mm"/><DIAGONAL Type="Solid" Width="0.12mm"/></BORDERFILL>
					<BORDERFILL BackSlash="0" BreakCellSeparateLine="0" CenterLine="0" CounterBackSlash="0" CounterSlash="0" CrookedSlash="0" Id="34" Shadow="false" Slash="0" ThreeD="false"><LEFTBORDER Type="Solid" Width="0.12mm"/><RIGHTBORDER Type="Solid" Width="0.12mm"/><TOPBORDER Type="None" Width="0.12mm"/><BOTTOMBORDER Type="Solid" Width="0.3mm"/><DIAGONAL Type="Solid" Width="0.12mm"/></BORDERFILL>
<BORDERFILL Id="35" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<RIGHTBORDER Type="Solid" Width="0.12mm" Color="0"/>
<TOPBORDER Type="Solid" Width="0.12mm" Color="0"/>
<BOTTOMBORDER Type="Solid" Width="0.12mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.1mm" Color="0"/>
</BORDERFILL>
<BORDERFILL Id="36" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="None" Width="0.12mm" Color="0"/>
<RIGHTBORDER Type="None" Width="0.12mm" Color="0"/>
<TOPBORDER Type="None" Width="0.12mm" Color="0"/>
<BOTTOMBORDER Type="None" Width="0.12mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.1mm" Color="0"/>
</BORDERFILL>
<BORDERFILL Id="37" ThreeD="false" Shadow="false" Slash="0" BackSlash="0" CrookedSlash="0"><LEFTBORDER Type="None" Width="0.1mm" Color="0"/>
<RIGHTBORDER Type="None" Width="0.1mm" Color="0"/>
<TOPBORDER Type="None" Width="0.1mm" Color="0"/>
<BOTTOMBORDER Type="None" Width="0.1mm" Color="0"/>
<DIAGONAL Type="Solid" Width="0.1mm" Color="0"/>
<FILLBRUSH><WINDOWBRUSH FaceColor="4294967295" HatchColor="0"/>
</FILLBRUSH>
</BORDERFILL>
</BORDERFILLLIST>
<CHARSHAPELIST Count="81">
<CHARSHAPE Id="0" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="2" Latin="2" Hanja="2" Japanese="2" Other="2" Symbol="2" User="2"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="1" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="2" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="1" Latin="1" Hanja="1" Japanese="1" Other="1" Symbol="1" User="1"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="3" Height="900" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="4" Height="900" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="1" Latin="1" Hanja="1" Japanese="1" Other="1" Symbol="1" User="1"/>
	<RATIO Hangul="95" Latin="95" Hanja="95" Japanese="95" Other="95" Symbol="95" User="95"/>
	<CHARSPACING Hangul="-5" Latin="-5" Hanja="-5" Japanese="-5" Other="-5" Symbol="-5" User="-5"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="5" Height="900" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="95" Latin="95" Hanja="95" Japanese="95" Other="95" Symbol="95" User="95"/>
	<CHARSPACING Hangul="-5" Latin="-5" Hanja="-5" Japanese="-5" Other="-5" Symbol="-5" User="-5"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="6" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{조문폰트}<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="7" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{법령명폰트}<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="8" Height="900" TextColor="16711680" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="2" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="9" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="10" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="-50" Latin="-50" Hanja="-50" Japanese="-50" Other="-50" Symbol="-50" User="-50"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="11" Height="1200" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{법령명폰트}<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="12" Height="1200" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="13" Height="1100" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="14" Height="1400" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="15" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="4" Japanese="4" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="16" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="17" Height="1700" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="18" Height="1600" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="4" Japanese="4" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="19" Height="1400" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="20" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="4" Japanese="4" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="21" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="6" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="22" Height="1300" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="23" Height="2000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="24" Height="1400" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="25" Height="1600" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="26" Height="3200" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="5" Latin="5" Hanja="5" Japanese="0" Other="5" Symbol="5" User="5"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
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	<RATIO Hangul="100" Hanja="100" Japanese="100" Latin="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Hanja="100" Japanese="100" Latin="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE BorderFillId="0" Height="900" Id="61" ShadeColor="4294967295" SymMark="0" TextColor="0" UseFontSpace="false" UseKerning="false">
	<FONTID Hangul="3" Hanja="3" Japanese="3" Latin="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Hanja="97" Japanese="97" Latin="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Hanja="100" Japanese="100" Latin="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Hanja="0" Japanese="0" Latin="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="62" Height="1000" TextColor="16711680" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="63" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="64" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="1" Latin="1" Hanja="1" Japanese="1" Other="1" Symbol="1" User="1"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="65" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="3" Latin="3" Hanja="0" Japanese="0" Other="3" Symbol="3" User="3"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="66" Height="1000" TextColor="255" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="3" Latin="3" Hanja="0" Japanese="0" Other="3" Symbol="3" User="3"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="67" Height="2000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="4" Japanese="4" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="68" Height="1600" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="7" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="69" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="4" Japanese="2" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="70" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="6" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="71" Height="1300" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="72" Height="2000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="73" Height="3200" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="5" Latin="5" Hanja="5" Japanese="0" Other="5" Symbol="5" User="5"/>
<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<BOLD/>
</CHARSHAPE>
<CHARSHAPE Id="74" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0"><FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="75" Height="1000" TextColor="16711680" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
<FONTID Hangul="2" Latin="2" Hanja="2" Japanese="2" Other="2" Symbol="2" User="2"/>
<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="76" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{법령명폰트}<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	{볼드}
</CHARSHAPE>
<CHARSHAPE Id="77" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="78" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="3" Latin="3" Hanja="3" Japanese="3" Other="3" Symbol="3" User="3"/>
	<RATIO Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="79" Height="900" TextColor="16711680" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="2" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
<CHARSHAPE Id="80" Height="1000" TextColor="0" ShadeColor="4294967295" UseFontSpace="false" UseKerning="false" SymMark="0">
	{조문폰트}<FONTID Hangul="4" Latin="4" Hanja="0" Japanese="0" Other="4" Symbol="4" User="4"/>
	<RATIO Hangul="97" Latin="97" Hanja="97" Japanese="97" Other="97" Symbol="97" User="97"/>
	<CHARSPACING Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
	<RELSIZE Hangul="100" Latin="100" Hanja="100" Japanese="100" Other="100" Symbol="100" User="100"/>
	<CHAROFFSET Hangul="0" Latin="0" Hanja="0" Japanese="0" Other="0" Symbol="0" User="0"/>
</CHARSHAPE>
</CHARSHAPELIST>
<TABDEFLIST Count="4"><TABDEF Id="0" AutoTabLeft="false" AutoTabRight="false"/>
<TABDEF Id="1" AutoTabLeft="true" AutoTabRight="false"/>
<TABDEF Id="2" AutoTabLeft="false" AutoTabRight="true"/>
<TABDEF Id="3" AutoTabLeft="false" AutoTabRight="false"><TABITEM Pos="86662" Type="Right" Leader="Dot"/>
</TABDEF>
</TABDEFLIST>
<NUMBERINGLIST Count="1"><NUMBERING Id="1" Start="0"><PARAHEAD Level="1" Alignment="Left" UseInstWidth="true" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit">^1.</PARAHEAD>
<PARAHEAD Level="2" Alignment="Left" UseInstWidth="true" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="HangulSyllable">^2.</PARAHEAD>
<PARAHEAD Level="3" Alignment="Left" UseInstWidth="true" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit">^3)</PARAHEAD>
<PARAHEAD Level="4" Alignment="Left" UseInstWidth="true" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="HangulSyllable">^4)</PARAHEAD>
<PARAHEAD Level="5" Alignment="Left" UseInstWidth="false" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit"></PARAHEAD>
<PARAHEAD Level="6" Alignment="Left" UseInstWidth="false" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit"></PARAHEAD>
<PARAHEAD Level="7" Alignment="Left" UseInstWidth="false" AutoIndent="true" WidthAdjust="0" TextOffsetType="percent" TextOffset="50" CharShape="0" NumFormat="Digit"></PARAHEAD>
</NUMBERING>
</NUMBERINGLIST>
<PARASHAPELIST Count="77"><PARASHAPE Id="0" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="1" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="-2620" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="1" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="true"><PARAMARGIN Indent="0" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="2" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="3" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="3000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="4" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="2000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="5" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="1" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="4000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="6" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="2" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="6000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="7" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="3" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="8000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="8" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="4" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="10000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="9" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="5" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="12000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="10" Align="Justify" VerAlign="Baseline" HeadingType="Outline" Heading="0" Level="6" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="true" Condense="20" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="14000" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="11" Align="Justify" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="2" BreakLatinWord="KeepWord" BreakNonLatinWord="false" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="150"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="12" Align="Right" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="false" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="13" Align="Right" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="false" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="100"/>
<PARABORDER BorderFill="1" OffsetLeft="0" OffsetRight="0" OffsetTop="0" OffsetBottom="0" Connect="false" IgnoreMargin="false"/>
</PARASHAPE>
<PARASHAPE Id="14" Align="Right" VerAlign="Baseline" HeadingType="None" Heading="0" Level="0" TabDef="0" BreakLatinWord="KeepWord" BreakNonLatinWord="false" Condense="0" WidowOrphan="false" KeepWithNext="false" KeepLines="false" PageBreakBefore="false" FontLineHeight="false" SnapToGrid="false"><PARAMARGIN Indent="0" Left="0" Right="0" Prev="0" Next="0" LineSpacingType="Percent" LineSpacing="130"/>
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{법령집표지}
{인쇄저장표지}
{머리글}
{목차영역}
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<P ParaShape="2"><TEXT CharShape="6"/></P>
<P ParaShape="2"><TEXT CharShape="7"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;개정이유&nbsp;</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>[일부개정]</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>◇ 개정이유</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  현재 의료인 등에게 제공이 예외적으로 허용되고 있는 견본품 제공, 학술대회 지원, 임상시험 지원 등 일부 경제적 이익의 제공이 금지 대상인 의료기기 판매촉진과 관련된 것인지 구분이 쉽지 않고 이에 대한 적발 또한 쉽지 않아 이에 대한 대책으로, 의료기기 제조업자 등에게 경제적 이익 제공에 관한 지출보고서 작성의 의무를 부과하고, 관련 장부 및 근거자료를 5년간 보관하도록 하도록 하여 의료기기 제조업자등의 자정능력을 강화하고 의료기기 시장의 투명성을 확보하려는 것임.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  한편, 현행법은 의료기기의 제조ㆍ수입 단계부터 유통 단계에 이르기까지 관련 현황을 파악할 수 있는 근거가 미비하는 등 의료기기의 생산부터 안전 사용까지 전주기(全週期)를 관리할 수 있는 시스템 구축 마련이 시급하다는 의견이 제시되고 있음. 이에 의료기기 표준코드를 표기하도록 하고, 제조업자 등에게 공급내역 보고를 의무화 하며, 의료기기통합정보시스템을 구축ㆍ운영하도록 하는 것임.  </CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>◇ 주요내용</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  가. 의료기기 제조업자가 회계연도 종료 후 3개월 이내에 의료인ㆍ의료기관 개설자 또는 의료기관 종사자에게 제공한 경제적 이익등 내역에 관한 지출보고서를 작성하고, 관련 장부 및 근거 자료를 5년간 보관하도록 하며, 보건복지부장관은 필요하다고 인정되는 경우 지출보고서와 관련 장부 및 근거 자료의 제출을 요구할 수 있도록 함(제13조의2 신설). </CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  나. 보건복지부장관은 제조업자 또는 수입업자가 지출보고서를 작성하지 아니하거나 해당 지출보고서와 관련 장부 및 근거 자료를 보관하지 아니한 경우 일정한 기간을 정하여 그 위반 사항을 시정하도록 명할 수 있도록 함(제35조의2 신설).</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  다. 의료기기의 판매촉진을 목적으로 의료인 등에게 경제적 이익을 제공한 경우 3년 이하의 징역 또는 3천만원 이하의 벌금에 처하도록 함(제53조).</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  라. 의료기기 표준코드의 정의를 신설하고, 의료기기의 용기나 외장에 기재하도록 함(제2조 및 제20조).</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  마. 의료기기 제조업자ㆍ수입업자ㆍ판매업자ㆍ임대업자는 의료기관, 의료기기 판매업자ㆍ임대업자에게 의료기기를 공급한 경우 식품의약품안전처장에게 그 공급내역을 보고하도록 함(제31조의2 신설).</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  바. 식품의약품안전처장이 허가부터 제조ㆍ수입ㆍ판매ㆍ사용에 이르기까지 의료기기에 관한 정보를 효율적으로 기록ㆍ관리하기 위하여 의료기기통합정보시스템을 구축ㆍ운영할 수 있도록 하고, 제조업자등은 의료기기 표준코드 및 의료기기에 관한 정보 등을 의료기기통합정보관리기준을 준수하여 의료기기통합정보시스템에 등록하도록 함(제31조의3 신설).</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  사. 식품의약품안전처장은 의료기기 정보의 수집ㆍ조사ㆍ가공ㆍ이용ㆍ제공 및 의료기기통합정보시스템의 구축ㆍ운영 등에 관한 업무를 의료기기통합정보센터에 위탁할 수 있도록 하고 그 운영에 사용되는 비용을 지원할 수 있도록 함(제31조의4 신설).</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  아. 벌금액을 징역 1년 당 1천만원으로 개정함(제51조, 제52조 및 제53조의2).  </CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>&lt;법제처 제공&gt;</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="2"><TEXT CharShape="6"/></P>
<P ParaShape="2"><TEXT CharShape="7"><CHAR>&nbsp;&nbsp;&nbsp;&nbsp;개정문&nbsp;</CHAR></TEXT><TEXT CharShape="8"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>국회에서 의결된 의료기기법 일부개정법률을 이에 공포한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>          대통령        박근혜 (인)</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>    2016년 12월 2일</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>          국무총리        황교안</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>          국무위원 보건복지부 장관        정진엽</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>⊙법률 제14330호</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>의료기기법 일부개정법률</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>의료기기법 일부를 다음과 같이 개정한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제2조에 제4항을 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ④ 이 법에서 "의료기기 표준코드"란 의료기기를 식별하고 체계적ㆍ효율적으로 관리하기 위하여 용기나 외장 등에 표준화된 체계에 따라 표기되는 숫자, 바코드[전자태그(RFID tag)를 포함한다] 등을 말한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제13조의2를 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제13조의2(경제적 이익등 제공 내역에 관한 지출보고서 제출 등) ① 제조업자는 보건복지부령으로 정하는 바에 따라 매 회계연도 종료 후 3개월 이내에 의료인ㆍ의료기관 개설자 또는 의료기관 종사자에게 제공한 경제적 이익등 내역에 관한 지출보고서를 작성하고, 해당 지출보고서와 관련 장부 및 근거 자료를 5년간 보관하여야 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ② 보건복지부장관은 필요하다고 인정하는 경우 제1항에 따른 지출보고서와 관련 장부 및 근거 자료의 제출을 요구할 수 있다. 이 경우 제조업자는 정당한 사유가 없으면 이에 따라야 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제15조제6항 전단 중 "제9조까지 및"을 "제9조까지,"로, "제14조까지의 규정을"을 "제13조까지, 제13조의2 및 제14조를"로 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제16조제4항 전단 중 "제12조부터 제14조까지의 규정을"을 "제12조, 제13조 및 제14조를"로 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제18조에 제3항을 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ③ 제2항에 따른 판매업자ㆍ임대업자에 대하여는 제13조의2를 준용한다. 이 경우 "제조업자"는 "판매업자 또는 임대업자"로 본다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제20조에 제8호를 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  8. 식품의약품안전처장이 보건복지부장관과 협의하여 정하는 의료기기 표준코드</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제5장에 제31조의2부터 제31조의4까지를 각각 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제31조의2(의료기기 공급내역 보고 등) ① 의료기기 제조업자ㆍ수입업자ㆍ판매업자ㆍ임대업자는 의료기관, 의료기기 판매업자ㆍ임대업자에게 의료기기를 공급한 경우 식품의약품안전처장이 보건복지부장관과 협의하여 총리령으로 정하는 바에 따라 식품의약품안전처장에게 그 공급내역을 보고하여야 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ② 보건복지부장관은 식품의약품안전처장에게 제1항에 따라 보고받은 자료를 제공하여 줄 것을 요청할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ③ 식품의약품안전처장은 의료기기 유통정보를 효율적으로 활용하기 위하여 보건복지부 등 관계 기관의 직원으로 구성된 협의체를 운영할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제31조의3(의료기기통합정보시스템 구축 등) ① 식품의약품안전처장은 허가부터 제조ㆍ수입ㆍ판매ㆍ사용에 이르기까지 의료기기에 관한 정보를 효율적으로 기록ㆍ관리하기 위하여 전자정보처리시스템(이하 "의료기기통합정보시스템"이라 한다)을 구축ㆍ운영할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ② 제조업자등은 의료기기를 체계적ㆍ효율적으로 관리하기 위하여 필요한 정보로서 의료기기 표준코드 및 의료기기에 관한 정보 등 총리령으로 정하는 정보를 제1항에 따른 의료기기통합정보시스템에 등록하여야 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ③ 제조업자등은 제2항에 따른 정보를 등록ㆍ관리함에 있어서 총리령으로 정하는 기준(이하 "의료기기통합정보관리기준"이라 한다)을 준수하여야 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ④ 의료기기통합정보시스템은 의료기기와 관련된 정보시스템과 전자적으로 연계하여 활용할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ⑤ 그 밖에 의료기기통합정보시스템의 구축ㆍ운영 및 관리 등에 필요한 사항은 총리령으로 정한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제31조의4(의료기기통합정보센터 지정ㆍ운영 등) ① 식품의약품안전처장은 의료기기 정보의 수집ㆍ조사ㆍ가공ㆍ이용ㆍ제공 및 제31조의3에 따른 의료기기통합정보시스템의 구축ㆍ운영 등에 관한 업무를 대통령령으로 정하는 바에 따라 관계 전문기관 또는 단체를 지정(이하 "의료기기통합정보센터"라고 한다)하여 위탁할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ② 의료기기통합정보센터의 장은 국가, 지방자치단체, 공공기관, 의료기기취급자 등을 대상으로 보고ㆍ제출받은 정보의 진위 여부를 확인하는 등 제1항에 따른 업무를 수행하는 데 필요한 경우에 한하여 그 업무와 관련성이 있는 자료 또는 정보의 제공을 요청할 수 있다. 이 경우 자료 또는 정보의 제공을 요청 받은 자는 정당한 사유가 없으면 이에 따라야 하며, 의료기기통합정보센터의 장에게 제공하는 자료에 대하여는 사용료 또는 수수료를 면제한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ③ 식품의약품안전처장 및 보건복지부장관은 의료기기통합정보센터의 장에게 의료기기 관리현황에 대하여 보고하게 할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ④ 식품의약품안전처장은 의료기기통합정보센터의 운영에 사용되는 비용의 전부 또는 일부를 지원할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ⑤ 의료기기통합정보센터의 운영 등에 필요한 사항은 총리령으로 정한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제35조의2를 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제35조의2(시정명령) 보건복지부장관은 제조업자가 제13조의2제1항(제15조제6항 또는 제18조제3항에서 준용하는 경우를 포함한다)에 따른 지출보고서를 작성하지 아니하거나 해당 지출보고서와 관련 장부 및 근거 자료를 보관하지 아니한 경우 일정한 기간을 정하여 그 위반 사항을 시정하도록 명할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제36조제1항에 제9호의2ㆍ제17호의2 및 제17호의3을 각각 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  9의2. 제13조제2항(제15조제6항에서 준용하는 경우를 포함한다)을 위반하여 의료기기의 생산실적, 수입실적 등을 보고하지 아니한 경우</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  17의2. 제31조의2제1항을 위반하여 의료기기 공급내역을 보고하지 아니하거나 거짓으로 보고한 경우</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  17의3. 제31조의3제2항을 위반하여 의료기기통합정보시스템에 정보를 등록하지 아니한 경우 또는 같은 조 제3항을 위반하여 의료기기통합정보관리기준을 준수하지 아니한 경우</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제51조제1항 중 "2천만원"을 "5천만원"으로 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제52조제1항 각 호 외의 부분 중 "1천만원"을 "3천만원"으로 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제53조 중 "2년"을 "3년"으로 한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>법률 제13698호 의료기기법 일부개정법률 제53조의2 중 "300만원"을 "1천만원"으로 한다</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제54조의2 제목 외의 부분을 제1항으로 하고, 같은 조에 제2항을 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ② 다음 각 호의 어느 하나에 해당하는 자는 200만원 이하의 벌금에 처한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  1. 제13조의2제1항(제15조제6항 또는 제18조제3항에서 준용하는 경우를 포함한다)을 위반하여 지출보고서를 작성하지 아니하거나 해당 지출보고서와 관련 장부 및 근거 자료를 보관하지 아니한 자</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  2. 제13조의2제1항(제15조제6항 또는 제18조제3항에서 준용하는 경우를 포함한다)에 따른 지출보고서를 거짓으로 작성한 자</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  3. 제13조의2제2항(제15조제6항 또는 제18조제3항에서 준용하는 경우를 포함한다)에 따른 지출보고서와 관련 장부 및 근거 자료의 제출요구를 따르지 아니한 자</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제56조제1항에 제2호의2 및 제2호의3을 각각 다음과 같이 신설한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  2의2. 제31조의2제1항을 위반하여 의료기기 공급내역을 보고하지 아니하거나 거짓으로 보고한 자</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  2의3. 제31조의3제2항을 위반하여 의료기기통합정보시스템에 정보를 등록하지 아니한 자 또는 같은 조 제3항을 위반하여 의료기기통합정보관리기준을 준수하지 아니한 자</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR></CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>          부칙</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제1조(시행일) 이 법은 공포한 날로부터 5년을 넘지 아니하는 범위에서 총리령으로 정하는 날부터 시행한다. 다만, 제13조의2, 제15조제6항, 제18조제3항, 제35조의2, 제54조의2제2항의 개정규정은 공포 후 6개월이 경과한 날부터 시행하고, 제51조제1항, 제52조제1항, 제53조의 개정규정은 공포한 날부터 시행한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제2조(법 시행을 위한 준비행위) 식품의약품안전처장은 이 법 시행 전에 의료기기에 관한 정보의 등록을 위한 시스템의 구축 및 운영 등에 필요한 조치를 할 수 있다. </CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제3조(지출보고서 제출 등에 관한 적용례) 제13조의2의 개정규정은 같은 개정규정 시행일이 속하는 회계연도의 다음 회계연도부터 적용한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제4조(용기 등 기재사항에 관한 적용례) 제20조제8호의 개정규정은 이 법 시행 후 최초로 제조 또는 수입하는 의료기기부터 적용한다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>제5조(시범사업의 특례) ① 식품의약품안전처장은 제31조의2, 제31조의3에 따른 사업을 원활히 추진하기 위하여 이 법 시행 전에 시범사업을 실시할 수 있다.</CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ② 식품의약품안전처장은 제1항에 따른 시범사업에 대하여 행정적ㆍ재정적 지원을 할 수 있다. </CHAR></TEXT><TEXT CharShape="6"/></P>
<P ParaShape="21"><TEXT CharShape="6"><CHAR>  ③ 제1항에 따른 시범사업의 실시에 관하여 필요한 사항은 식품의약품안전처장이 정한다.</CHAR></TEXT><TEXT CharShape="6"/></P>

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{국가법령이미지로고}
{이미지파일}
{QR코드이미지파일}
</BINDATASTORAGE>
</TAIL>
</HWPML>
