/></p><p>　　长期以来，水光针是作为化妆品监管还是医疗器械监管或者药品监管一直不明确。由《医疗器械分类目录》可知，宣称具有填充增加组织容积的整形用注射填充物归为第三类器械；宣称保湿、补水等作用，改善肌肤状态的不作为器械监管。比如HERA透明质酸钠弹润面膜、赫妍透明质酸钠弹润眼膜等，这类产品作为化妆品管理。需要注意的是，作为化妆品管理的产品，其用途为外敷或涂抹，而非通过注射使用。“水光针”的预期用途和使用方法与医疗器械或化妆品的描述均存在矛盾之处。在医美市场，“水光针”的注射乱象层出不穷，比如产品滥用，超范围、超剂量注射等，对于被注射者来说都存在较大安全隐患，必将引起监管部门的重视。</p><p><br/></p><p>　　医疗器械产品的申报首先要确定产品的分类。我国对医疗器械按照风险程度实行分类管理，风险从低到高分为三类，通常可以参考《医疗器械分类目录》《医疗器械分类规则》等相关法规和文件来确定。像菲洛嘉、润百颜、东国、LG等品牌的水光针除了以透明质酸钠、透明质酸等为主要成分外，可能还添加维生素、矿物质、利多卡因等成分，甚至有些产品还添加有核酸、氨基酸、辅酶等蛋白类或具有活性的物质。对于成分比较复杂的产品，建议先申请医疗器械分类界定。含有药品成分的，建议先申请药械属性界定，确定产品分类，再依据具体分类制定注册方案。</p><p><br/></p><p>　　（瑞旭集团-北京西尔思科技有限公司供稿）</p><p><br/></p></p>
				                                  
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                referdata: true
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    function initCommentList(data) {
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