国家药监局：美容用途超声器械进入分类监管，四大类按医疗器械管理！
<div align="left"><section data-role="outer" class="article135" label="edit by 135editor"><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;"><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">本月23日，国家药品监督管理局医疗器械标准管理中心组织起草《美容用途超声器械分类界定指导原则》，向社会公开征求意见。（文章末尾附原文&附件）</span></span></span></section><span style="color: rgb(0, 0, 0); font-family: Tahoma, Simsun;"><img width="1080" _height="334" src="https://pic2.zhimg.com/80/v2-c859d6af16961fdc61777406fe648311_720w.webp" border="0" alt="" style="vertical-align: inherit; width: 100%; box-sizing: border-box; max-width: 100% !important;"></span><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;"><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">这是自2021年4月16日，国家药监局对射频美容类产品，制定分类界定指导原则。时隔2年半，再次对美容类器械制定分类界定指导原则。</span></span></span></section><span style="color: rgb(0, 0, 0); font-family: Tahoma, Simsun;"><img width="1080" _height="329" src="https://pic2.zhimg.com/80/v2-ef354304c97b086fb0f96e3765a8a259_720w.webp" border="0" alt="" style="vertical-align: inherit; width: 100%; box-sizing: border-box; max-width: 100% !important;"></span><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">于是，为促进超声美容类产品的高质量发展和科学监管，国家药监局发布了这则，关于征求《美容用途超声器械分类界定指导原则（征求意见稿）》（以下简称：《原则》）意见的通知，以规范在医疗器械领域中美容用途超声产品的分类界定，并为产业和监管部门提供注册和审批的技术指导。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">四大类将纳入医疗器械范畴监管</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">《原则》首先对美容用途超声器械进行定义，即：“以超声波作为物理因子的美容用途器械。”同时，按照《原则》，以下四大类射频美容类产品将被纳入医疗器械管理范畴。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">《原则》还对美容用途超声器械进行了分类。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><strong></strong><section data-role="paragraph" class="_135editor"><p><br></p></section><section class="_135editor" data-role="title" data-tools="135编辑器" data-id="129846"><section style="margin: 10px auto; display: flex; align-items: flex-end;"><section style="flex-shrink: 0;"><section class="assistant" style="width: 18px;box-sizing:border-box;"><img class="assistant" style="width: 100%; display: block;vertical-align:inherit;box-sizing:border-box;max-width: 100% !important;" src="https://bcn.135editor.com/files/images/editor_styles/d2c33dbcaf2e050186e83d0263a221eb.gif" data-width="100%" draggable="false" data-ratio="1.7669256381798002" data-w="901"></section></section><section style="border-bottom: 1px solid #bb7742;width: 100%;text-align: center;max-width: 100% !important;box-sizing:border-box;" data-width="100%"><section style="color: rgb(187, 119, 66); padding: 2px 10px; box-sizing: border-box;" class=""><strong class="135brush" data-brushtype="text">作为第三类医疗器械管理的是（包括但不限于）：</strong></section></section><section style="flex-shrink: 0; margin-left: -25px;"><section style="width: 30px;box-sizing:border-box;"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 136.29 45.69" style="display: block;" xml:space="default"><g><g><path style="fill:#c79064;" d="M131.36,21.84v0h-116C12.56,18.22,8.1,10.22,15.21,2H73V0H4.93s-11.09,10.15,0,23.83h116c2.82,3.61,7.31,11.63.15,19.87H63.3v2h65.07v0h3S142.45,35.51,131.36,21.84Z"></path></g></g></svg></section></section></section></section></span></span></span></section><section data-role="paragraph" class=""><p><br></p></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">（1）用于通过手术手段消溶脂肪，以达到塑身目的（可用于肥胖症的治疗、健康人群塑型等）的超声脂肪乳化、脂肪溶解器械按照第三类医疗器械管理。</span></span></span></section><section data-role="paragraph"><p><br></p></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">（2）利用高频超声波的热效应、机械效应和超声空化等，使人体组织变性，如刺激胶原蛋白的再生和增生等，从而达到<strong>治疗痤疮、淡化色斑、淡化瘢痕痕迹、修复疤痕、改善皮肤弹性</strong>和<strong>减少皱纹</strong>等目的的超声美容器械按照第三类医疗器械管理。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><br></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><strong></strong><section class="_135editor" data-role="title" data-tools="135编辑器" data-id="129846"><section style="margin: 10px auto; display: flex; align-items: flex-end;"><section style="flex-shrink: 0;"><section class="assistant" style="width: 18px;box-sizing:border-box;"><img class="assistant" style="width: 100%; display: block;vertical-align:inherit;box-sizing:border-box;max-width: 100% !important;" src="https://bcn.135editor.com/files/images/editor_styles/d2c33dbcaf2e050186e83d0263a221eb.gif" data-width="100%" draggable="false" data-ratio="1.7669256381798002" data-w="901"></section></section><section style="border-bottom: 1px solid #bb7742;width: 100%;text-align: center;max-width: 100% !important;box-sizing:border-box;" data-width="100%"><section style="color: rgb(187, 119, 66); padding: 2px 10px; box-sizing: border-box;" class=""><strong class="135brush" data-brushtype="text">作为第二类医疗器械管理的是（包括但不限于）：</strong></section></section><section style="flex-shrink: 0; margin-left: -25px;"><section style="width: 30px;box-sizing:border-box;"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 136.29 45.69" style="display: block;" xml:space="default"><g><g><path style="fill:#c79064;" d="M131.36,21.84v0h-116C12.56,18.22,8.1,10.22,15.21,2H73V0H4.93s-11.09,10.15,0,23.83h116c2.82,3.61,7.31,11.63.15,19.87H63.3v2h65.07v0h3S142.45,35.51,131.36,21.84Z"></path></g></g></svg></section></section></section></section></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><br></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">（1）利用超声波的能量，在不发生组织变性的情况下，通过<strong>促进局部血液循环</strong>，<strong>加快皮肤新陈代谢</strong>等实现美容目的的超声美容器械按照第二类医疗器械管理。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><br></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">（2）利用超声作用，将药品和医疗器械经过皮肤或黏膜透入人体的超声美容器械按照第二类医疗器械管理。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><br></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><br></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><strong></strong><section class="_135editor" data-role="title" data-tools="135编辑器" data-id="129846"><section style="margin: 10px auto; display: flex; align-items: flex-end;"><section style="flex-shrink: 0;"><section class="assistant" style="width: 18px;box-sizing:border-box;"><img class="assistant" style="width: 100%; display: block;vertical-align:inherit;box-sizing:border-box;max-width: 100% !important;" src="https://bcn.135editor.com/files/images/editor_styles/d2c33dbcaf2e050186e83d0263a221eb.gif" data-width="100%" draggable="false" data-ratio="1.7669256381798002" data-w="901"></section></section><section style="border-bottom: 1px solid #bb7742;width: 100%;text-align: center;max-width: 100% !important;box-sizing:border-box;" data-width="100%" class=""><section style="color: rgb(187, 119, 66); padding: 2px 10px; box-sizing: border-box;" class=""><strong class="135brush" data-brushtype="text">不作为医疗器械管理的是（包括但不限于）：</strong></section></section><section style="flex-shrink: 0; margin-left: -25px;"><section style="width: 30px;box-sizing:border-box;"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 136.29 45.69" style="display: block;" xml:space="default"><g><g><path style="fill:#c79064;" d="M131.36,21.84v0h-116C12.56,18.22,8.1,10.22,15.21,2H73V0H4.93s-11.09,10.15,0,23.83h116c2.82,3.61,7.31,11.63.15,19.87H63.3v2h65.07v0h3S142.45,35.51,131.36,21.84Z"></path></g></g></svg></section></section></section></section></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><br></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">（1）仅用于导入护肤品，不用于导入药品和医疗器械的超声波美容器械不作为医疗器械管理。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><br></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">（2）仅用于利用超声波去除毛孔内物质、清洁皮肤的超声波美容器械不作为医疗器械管理。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);"><br></span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;" class=""><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">放眼未来，《美容用途超声器械分类界定指导原则》的发布是国家对美容用途超声器械的市场加强监管迈出的重要一步，预示着已经通过相关标准的订立对快速发展的美容类产品形成约束和监管。相信在不久的未来，随着各类安全生产和检验标准的逐步建立，国内美容用途器械市场将会迎来更健康，更有保障的发展空间。</span></span></span></section><section align="left" style="box-sizing: border-box; font-family: Tahoma, Simsun;"><span style="font-family: -apple-system, BlinkMacSystemFont, ";";"><span style="font-size: 16px;"><span style="color: rgb(0, 0, 0);">附件如下：</span></span></span></section><section class="_135editor" data-role="paragraph"><p><br></p></section></section></div><br><img width="1080" _height="2044" src="https://pic1.zhimg.com/80/v2-b180e56cf569c0371608b216c7833f84_720w.webp" border="0" alt=""><br><font color="rgb(0, 0, 0)"><font face="微软雅黑"><font style="font-size: 16px"><p style="line-height: 40px; text-indent: nullem; text-align: right;">医疗器械标准管理中心</p><p style="line-height: 40px; text-indent: nullem; text-align: right;">2023年11月23日</p></font></font></font><br><font color="rgb(0, 0, 0)"><font face="微软雅黑"><font style="font-size: 18px">【附件】</font><br><ul><li><img src="https://www.nifdc.org.cn/directory/web/fileTypeImages/icon_doc.gif" border="0" alt="" style="max-width:400px"> <font color="#333333"><a href="https://www.nifdc.org.cn/directory/web/nifdc/infoAttach/f1a36667-a3aa-4d52-a449-369fc4bfc177.doc" target="_blank">附件1:《美容用途超声器械分类界定指导原则（征求意见稿）》.doc</a></font></li><li><img src="https://www.nifdc.org.cn/directory/web/fileTypeImages/icon_doc.gif" border="0" alt="" style="max-width:400px"> <font color="#333333"><a href="https://www.nifdc.org.cn/directory/web/nifdc/infoAttach/c56dc47e-f911-45bb-9ac4-9169c8781ed5.doc" target="_blank">附件2:编制说明.doc</a></font></li><li><img src="https://www.nifdc.org.cn/directory/web/fileTypeImages/icon_doc.gif" border="0" alt="" style="max-width:400px"> <font color="#333333"><a href="https://www.nifdc.org.cn/directory/web/nifdc/infoAttach/1e929213-56b7-4671-9dd4-e721fcb38260.doc" target="_blank">附件3:征求意见表.doc</a></font><br></li></ul></font></font><br><br><br><div align="left"><font color="rgb(25, 27, 31)"><font face="-apple-system, BlinkMacSystemFont, ""><font size="3">原文链接：<font face="Tahoma, ""><font style="font-size: 14px"><a href="https://www.nifdc.org.cn/nifdc/bshff/ylqxbzhgl/qxzqyj/20231123101559846126.html" target="_blank">关于征求《美容用途超声器械分类界定指导原则（征求意见稿）》意见的通知</a></font></font></font></font></font></div><br><br>美容用途超声器械分类界定指导原则 （征求意见稿）
附件1美容用途超声器械分类界定指导原则（征求意见稿）一、目的
为指导美容用途超声器械的管理属性和管理类别判定，根据《医疗器械监督管理条例》《医疗器械分类规则》和《医疗器械分类目录》等制定本原则。
二、范围
本原则适用于以超声波作为物理因子的美容用途器械的管理属性和管理类别判定。
三、管理属性和管理类别界定
根据《医疗器械监督管理条例》《医疗器械分类规则》和《医疗器械分类目录》等，美容用途超声器械具体属性界定原则如下：
1.符合“医疗器械定义”[见《医疗器械监督管理条例》（中华人民共和国国务院令（第739号））的美容用途超声器械应作为医疗器械管理。包括但不限于：
（1）用于通过手术手段消溶脂肪，以达到塑身目的（可用于肥胖症的治疗、健康人群塑型等）的超声脂肪乳化、脂肪溶解器械按照第三类医疗器械管理。（2）利用高频超声波的热效应、机械效应和超声空化等，使人体组织变性，如刺激胶原蛋白的再生和增生等，从而达到治疗痤疮、淡化色斑、淡化瘢痕痕迹、修复疤痕、改善皮肤弹性和减少皱纹等目的的超声美容器械按照第三类医疗器械管理。（3）利用超声波的能量，在不发生组织变性的情况下，通过促进局部血液循环，加快皮肤新陈代谢等实现美容目的的超声美容器械按照第二类医疗器械管理。（4）利用超声作用，将药品和医疗器械经过皮肤或黏膜透入人体的超声美容器械按照第二类医疗器械管理。
2.不作为医疗器械管理的美容用途超声器械，包括但不限于：
（1）仅用于导入护肤品，不用于导入药品和医疗器械的超声波美容器械不作为医疗器械管理。（2）仅用于利用超声波去除毛孔内物质、清洁皮肤的超声波美容器械不作为医疗器械管理。
四、本原则自发布实施之日起施行。
《美容用途超声器械分类界定指导原则》 编制说明
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color:rgb(0,0,0);font-size:15.0000pt;mso-font-kerning:1.0000pt;">《美容用途超声器械分类界定指导原则》</span><span style="mso-spacerun:'yes';font-family:方正小标宋简体;mso-hansi-font-family:'Times New Roman';
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color:rgb(0,0,0);font-size:15.0000pt;mso-font-kerning:1.0000pt;">编制说明</span><span style="mso-spacerun:'yes';font-family:方正小标宋简体;mso-hansi-font-family:'Times New Roman';
color:rgb(0,0,0);font-size:15.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" align="center" style="mso-pagination:widow-orphan;text-align:center;line-height:29.5000pt;
mso-line-height-rule:exactly;"><span style="mso-spacerun:'yes';font-family:Calibri;mso-fareast-font-family:方正仿宋简体;
font-size:15.0000pt;mso-font-kerning:1.0000pt;"> </span></p><p class="p" align="justify" style="margin-top: 6pt; margin-bottom: 0pt; margin-left: 0pt; text-indent: 21pt; text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><!----><span style="font-family:黑体;mso-bidi-font-family:'Times New Roman';font-size:14.0000pt;
mso-font-kerning:1.0000pt;">一、</span><!----><span style="mso-spacerun:'yes';font-family:黑体;mso-bidi-font-family:'Times New Roman';
font-size:14.0000pt;mso-font-kerning:1.0000pt;">工作简况</span><span style="mso-spacerun:'yes';font-family:黑体;mso-bidi-font-family:'Times New Roman';
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="text-indent:28.0000pt;mso-char-indent-count:2.0000;mso-pagination:widow-orphan;
line-height:29.5000pt;mso-line-height-rule:exactly;"><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-bidi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">为科学合理的判定美容用途超声器械产品风险，规范相关产品的分类界定工作，根据国家药品监督管理局（以下简称国家药监局）工作部署，由国家药品监督管理局医疗器械标准管理中心（以下简称标管中心）牵头组织开展《美容用途超声器械分类界定指导原则》编制工作。按照国家药监局要求，标管中心制定了工作方案，会同医疗器械分类技术委员会物理治疗器械专业组，研究编制了《美容用途超声器械分类界定指导原则》。</span><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-bidi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="margin-left:0.0000pt;text-indent:21.0000pt;mso-pagination:widow-orphan;
line-height:29.5000pt;mso-line-height-rule:exactly;mso-list:l0 level1 lfo1;"><!----><span style="font-family:黑体;font-size:14.0000pt;mso-font-kerning:1.0000pt;">二、</span><!----><span style="mso-spacerun:'yes';font-family:黑体;font-size:14.0000pt;
mso-font-kerning:1.0000pt;">编写原则和意义</span><span style="mso-spacerun:'yes';font-family:黑体;font-size:14.0000pt;
mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="text-indent:35.0000pt;mso-char-indent-count:2.5000;mso-pagination:widow-orphan;
line-height:29.5000pt;mso-line-height-rule:exactly;"><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;">目前，采用超声原理的美容产品已经广泛应用于医疗美容、生活美容等领域，但对于该类产品的管理属性界定和管理类别划分仅能依据《医疗器械监督管理条例》《医疗器械分类目录》等法规文件，尚无具体的指导原则。医疗器械分类技术委员会物理治疗器械专业组在梳理现有</span><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-bidi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">美容用途超声器械</span><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;">产品现状及相关分类政策的基础上，根据该类产品的特点和产品风险程度，依据《医疗器械监督管理条例》《医疗器械分类规则》《医疗器械分类目录》等编制了《</span><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-bidi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">美容用途超声器械分类界定指导原则</span><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;">》。本原则可用于规范</span><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-bidi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">容用途超声器械</span><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;">的分类界定，并为产业和监管部门提供注册和审批的技术依据。</span><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="margin-top:6.0000pt;mso-para-margin-top:0.5000gd;text-indent:21.0000pt;
mso-char-indent-count:1.5000;mso-pagination:widow-orphan;line-height:150%;"><span style="mso-spacerun:'yes';font-family:黑体;line-height:150%;
mso-bidi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;">三、重大问题的讨论</span><span style="mso-spacerun:'yes';font-family:黑体;line-height:150%;
mso-bidi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="margin-top:6.0000pt;mso-para-margin-top:0.5000gd;text-indent:28.0000pt;
mso-char-indent-count:2.0000;mso-layout-grid-align:none;layout-grid-mode:char;
line-height:150%;"><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">经医疗器械分类技术委员会物理治疗器械专业组讨论：</span><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="text-indent:28.0000pt;mso-char-indent-count:2.0000;mso-layout-grid-align:none;
layout-grid-mode:char;line-height:150%;"><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">（一）本原则中所指的美容，包括《</span><a href="http://www.gov.cn/gongbao/content/2005/content_64312.htm" title="中华人民共和国商务部令（2004年第19号）<br/>美容美发业管理暂行办法"><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">美容美发业管理暂行办法</span></a><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><font face="仿宋">》</font><font face="仿宋">[</font></span><a href="http://www.gov.cn/gongbao/content/2005/content_64312.htm" title="中华人民共和国商务部令（2004年第19号）<br/>美容美发业管理暂行办法"><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><font face="仿宋">中华人民共和国商务部令（</font><font face="仿宋">2004年第19号）</font></span></a><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">]中“第二条”规定的“美容”和《医疗美容服务管理办法》[</span><a href="http://www.gov.cn/gongbao/content/2003/content_62198.htm" title="中华人民共和国卫生部令（第19号）<br/>医疗美容服务管理办法"><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><font face="仿宋">中华人民共和国卫生部令（第</font><font face="仿宋">19号）</font></span></a><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">]中“第二条”规定的“医疗美容”。</span><span style="mso-spacerun:'yes';font-family:仿宋;line-height:150%;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="text-indent:28.0000pt;mso-char-indent-count:2.0000;mso-layout-grid-align:none;
layout-grid-mode:char;line-height:150%;"><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;line-height:150%;
color:rgb(0,0,0);font-size:14.0000pt;mso-font-kerning:1.0000pt;">注：</span><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;line-height:150%;
color:rgb(0,0,0);font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="text-indent:21.0000pt;mso-char-indent-count:2.0000;mso-layout-grid-align:none;
layout-grid-mode:char;line-height:150%;"><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><font face="Calibri">1.</font><font face="宋体">《</font></span><a href="http://www.gov.cn/gongbao/content/2005/content_64312.htm" title="中华人民共和国商务部令（2004年第19号）<br/>美容美发业管理暂行办法"><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;">美容美发业管理暂行办法</span></a><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><font face="宋体">》</font><font face="Calibri">[</font></span><a href="http://www.gov.cn/gongbao/content/2005/content_64312.htm" title="中华人民共和国商务部令（2004年第19号）<br/>美容美发业管理暂行办法"><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><font face="宋体">中华人民共和国商务部令（</font><font face="Calibri">2004</font><font face="宋体">年第</font><font face="Calibri">19</font><font face="宋体">号）</font></span></a><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><font face="Calibri">]</font><font face="宋体">中“第二条”规定“本办法所称美容，是指运用手法技术、器械设备并借助化妆、美容护肤等产品，为消费者提供人体表面无创伤性、非侵入性的皮肤清洁、皮肤保养、化妆修饰等服务的经营性行为。”</font></span><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><o:p></o:p></span></p><p class="MsoNormal" style="text-indent:21.0000pt;mso-char-indent-count:2.0000;mso-layout-grid-align:none;
layout-grid-mode:char;line-height:150%;"><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><font face="Calibri">2.</font><font face="宋体">《医疗美容服务管理办法》</font><font face="Calibri">[</font></span><a href="http://www.gov.cn/gongbao/content/2003/content_62198.htm" title="中华人民共和国卫生部令（第19号）<br/>医疗美容服务管理办法"><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><font face="宋体">中华人民共和国卫生部令（第</font><font face="Calibri">19</font><font face="宋体">号）</font></span></a><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><font face="Calibri">]</font><font face="宋体">中“第二条”规定“本办法所称医疗美容，是指运用手术、药物、医疗器械以及其他具有创伤性或者侵入性的医学技术方法对人的容貌和人体各部位形态进行的修复与再塑。”</font></span><span style="font-family: 宋体; color: rgb(0, 0, 0); font-size: 10.5pt; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;"><o:p></o:p></span></p><p class="MsoNormal" style="text-indent:28.0000pt;mso-char-indent-count:2.0000;mso-pagination:widow-orphan;
line-height:29.5000pt;mso-line-height-rule:exactly;"><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;">（二）本原则着重对于美容领域使用的超声设备进行管理属性界定，对于不具备医疗用途的产品明确不作为医疗器械管理，对于作为医疗器械管理的产品，从风险程度对管理类别进行划分。</span><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" style="text-indent:28.0000pt;mso-char-indent-count:2.0000;mso-pagination:widow-orphan;
line-height:29.5000pt;mso-line-height-rule:exactly;"><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;">（三）本原则仅根据当前</span><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-bidi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;">美容用途超声器械的应用领域提出了分类界定技术原则，随着相关技术和新产品的发展，该原则的内容需要随之补充和更新。</span><span style="mso-spacerun:'yes';font-family:仿宋;font-size:14.0000pt;
mso-font-kerning:1.0000pt;"><o:p></o:p></span></p>
《美容用途超声器械分类界定指导原则(征求意见稿)》征求意见表
<div align="left"><p class="MsoNormal"><span style="mso-spacerun:'yes';font-family:黑体;font-size:16.0000pt;mso-font-kerning:1.0000pt;">附件</span><span style="mso-spacerun:'yes';font-family:黑体;font-size:16.0000pt;
mso-font-kerning:1.0000pt;">3</span><span style="mso-spacerun:'yes';font-family:黑体;font-size:16.0000pt;
mso-font-kerning:1.0000pt;"><o:p></o:p></span></p><p class="MsoNormal" align="center" style="text-align:center;"><b><span style="mso-spacerun:'yes';font-family:宋体;mso-ascii-font-family:'Times New Roman';
mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;font-size:18.0000pt;
mso-font-kerning:1.0000pt;"><font face="宋体">《美容用途超声器械分类界定指导原则</font><font face="Times New Roman">(</font><font face="宋体">征求意见稿</font><font face="Times New Roman">)</font><font face="宋体">》征求意见表</font></span></b><b><span style="mso-spacerun:'yes';font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:18.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p><p class="MsoNormal" align="center" style="text-align:center;"><b><span style="mso-spacerun:'yes';font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></b></p><p class="MsoNormal" style="text-indent:21.0000pt;"><b><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';
mso-ansi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"><font face="仿宋_GB2312">提出单位：</font> <font face="仿宋_GB2312">提出日期：</font></span></b><b><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';
mso-ansi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p><p class="MsoNormal" style="text-indent:21.0000pt;"><b><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';
mso-ansi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"><font face="仿宋_GB2312">联系人</font><font face="仿宋_GB2312">/提出人：</font></span></b><b><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';
mso-ansi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></b><b><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';
mso-ansi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"> <font face="仿宋_GB2312">联系电话：</font></span></b><b><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';
mso-ansi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p><p class="MsoNormal" align="center" style="text-align:center;"><b><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';
mso-ansi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"> <font face="仿宋_GB2312">共</font> <font face="仿宋_GB2312">页</font> <font face="仿宋_GB2312">; 第 页</font></span></b><b><span style="mso-spacerun:'yes';font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';
mso-ansi-font-weight:bold;font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p><table class="MsoNormalTable" border="1" cellspacing="0" style="border: none;"><tbody><tr style="height:25.2500pt;"><td width="64" valign="center" style="width: 48.45pt; padding: 0pt 5.4pt; border-width: 1pt; border-color: windowtext;"><p class="MsoNormal" align="center" style="text-align:center;"><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:16.0000pt;mso-font-kerning:1.0000pt;">序号</span></b><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p></td><td width="106" valign="center" style="width: 80.15pt; padding: 0pt 5.4pt; border-width: 1pt; border-color: windowtext;"><p class="MsoNormal" align="center" style="text-align:center;"><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:16.0000pt;mso-font-kerning:1.0000pt;">章条编号</span></b><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p></td><td width="216" valign="center" style="width: 162pt; padding: 0pt 5.4pt; border-width: 1pt; border-color: windowtext;"><p class="MsoNormal" align="center" style="text-align:center;"><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:16.0000pt;mso-font-kerning:1.0000pt;">原内容</span></b><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p></td><td width="302" valign="center" style="width: 227.15pt; padding: 0pt 5.4pt; border-width: 1pt; border-color: windowtext;"><p class="MsoNormal" align="center" style="text-align:center;line-height:28.0000pt;mso-line-height-rule:exactly;"><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:16.0000pt;mso-font-kerning:1.0000pt;">修改后内容</span></b><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:16.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p><p class="MsoNormal" align="center" style="text-align:center;line-height:28.0000pt;mso-line-height-rule:exactly;"><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:16.0000pt;mso-font-kerning:1.0000pt;">（</span></b><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';color:rgb(255,0,0);
mso-ansi-font-weight:bold;font-size:16.0000pt;mso-font-kerning:1.0000pt;">修改处内容用红色标出</span></b><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:16.0000pt;mso-font-kerning:1.0000pt;">）</span></b><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p></td><td width="280" valign="center" style="width: 210.05pt; padding: 0pt 5.4pt; border-width: 1pt; border-color: windowtext;"><p class="MsoNormal" align="center" style="text-align:center;"><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:16.0000pt;mso-font-kerning:1.0000pt;">修改理由</span></b><b><span style="font-family:仿宋_GB2312;mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;
font-size:14.0000pt;mso-font-kerning:1.0000pt;"><o:p></o:p></span></b></p></td></tr><tr><td width="64" valign="top" style="width: 48.45pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="106" valign="top" style="width: 80.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="216" valign="top" style="width: 162pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="302" valign="top" style="width: 227.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="280" valign="top" style="width: 210.05pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td></tr><tr><td width="64" valign="top" style="width: 48.45pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="106" valign="top" style="width: 80.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="216" valign="top" style="width: 162pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="302" valign="top" style="width: 227.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="280" valign="top" style="width: 210.05pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td></tr><tr><td width="64" valign="top" style="width: 48.45pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="106" valign="top" style="width: 80.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="216" valign="top" style="width: 162pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="302" valign="top" style="width: 227.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="280" valign="top" style="width: 210.05pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td></tr><tr><td width="64" valign="top" style="width: 48.45pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="106" valign="top" style="width: 80.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="216" valign="top" style="width: 162pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="302" valign="top" style="width: 227.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="280" valign="top" style="width: 210.05pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td></tr><tr><td width="64" valign="top" style="width: 48.45pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="106" valign="top" style="width: 80.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="216" valign="top" style="width: 162pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="302" valign="top" style="width: 227.15pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td><td width="280" valign="top" style="width: 210.05pt; padding: 0pt 5.4pt; border-left-width: 1pt; border-left-color: windowtext; border-right-width: 1pt; border-right-color: windowtext; border-top: none; border-bottom-width: 1pt; border-bottom-color: windowtext;"><p class="MsoNormal"><span style="font-family:'Times New Roman';font-size:14.0000pt;mso-font-kerning:1.0000pt;"> </span></p></td></tr></tbody></table><p class="MsoNormal" align="right" style="margin-right:63.0000pt;text-align:right;"><span style="mso-spacerun:'yes';font-family:'Times New Roman';font-size:10.5000pt;
mso-font-kerning:1.0000pt;"> </span></p><p class="MsoNormal" style="margin-right:48.2000pt;text-indent:457.8000pt;mso-char-indent-count:38.0000;"><b><span style="mso-spacerun:'yes';font-family:宋体;mso-ascii-font-family:'Times New Roman';
mso-hansi-font-family:'Times New Roman';mso-ansi-font-weight:bold;font-size:12.0000pt;
mso-font-kerning:1.0000pt;"> </span></b><span style="mso-spacerun:'yes';font-family:'Times New Roman';font-size:10.5000pt;
mso-font-kerning:1.0000pt;"><o:p></o:p></span></p></div>
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