注意：这11类医械进入国家重点监管名录

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                    <section label="powered by gulangu"><p><p><img src="image/20200927/ec3510bde358d38e0701a5a8d18b1c62_1.gif" /></p></p><p><br  /></p><section label="powered by gulangu"><p>2016年1月4日，广东省食药监局印发了《广东省医疗器械重点监管目录》，其中包含11类医疗器械被重点监督，以下是具体被监管的医疗器械名单，供业内人士参考：</p><p><br  /></p><p><p><img src="image/20200927/887670a97ff89e1539a9164b3317c8a5_2.jpg" /></p><br  /></p><p><br  /></p><table cellspacing="0" cellpadding="0" width="670"><tbody><tr><td valign="top" width="219"><p><span><strong><span>所述类别</span></strong></span></p></td><td valign="top" width="240"><p><span><strong><span>医械名称</span></strong></span></p></td></tr><tr><td valign="top" width="219"><p><span>医用电子仪器设备</span></p></td><td valign="top" width="240"><p><span>1</span><span>、冲击波碎石仪</span></p><p><span>2</span><span>、气压弹道腔内碎石仪</span></p><p><span>3</span><span>、多参数监护仪(有创)</span></p></td></tr><tr><td valign="top" width="219"><p><span>医用超声仪器及有关设备</span></p></td><td valign="top" width="240"><p><span>1</span><span>、高强度聚焦超声治疗设备</span></p></td></tr><tr><td valign="top" width="219"><p><span>医用激光仪器设备</span></p></td><td valign="top" width="240"><p><span>1</span><span>、激光治疗仪</span></p></td></tr><tr><td valign="top" width="219"><p><span>医用高频仪器设备</span></p></td><td valign="top" width="240"><p><span>1</span><span>、高频电刀</span></p></td></tr><tr><td valign="top" width="219"><p><span>物理治疗及康复设备</span></p></td><td valign="top" width="240"><p><span>1</span><span>、高电位治疗仪</span></p><p><span>2</span><span>、超低频经颅磁刺激仪</span></p><p><span>3</span><span>、臭氧治疗仪</span></p><p><span>4</span><span>、一次性使用体腔热灌注治疗管道组件</span></p><p><span>5</span><span>、电磁治疗仪</span></p><p><span>6</span><span>、低频负压磁疗仪</span></p><p><span>7</span><span>、磁疗贴、远红外贴</span></p></td></tr><tr><td valign="top" width="219"><p><span>体外循环及血液处理设备</span></p></td><td valign="top" width="240"><p><span>1</span><span>、一次性使用动静脉穿刺针</span></p><p><span>2</span><span>、血液辐照仪</span></p></td></tr><tr><td valign="top" width="219"><p><span>手术室、急救室、诊疗室设备及器具</span></p></td><td valign="top" width="240"><p><span>1</span><span>、洁肠水疗仪</span></p><p><span>2</span><span>、肠道水疗仪</span></p></td></tr><tr><td valign="top" width="219"><p><span>口腔科材料</span></p></td><td valign="top" width="240"><p><span>1</span><span>、齿科种植体</span></p><p><span>2</span><span>、高分子义齿材料</span></p><p><span>3</span><span>、充填材料</span></p></td></tr><tr><td valign="top" width="219"><p><span>医用卫生材料及敷料</span></p></td><td valign="top" width="240"><p><span>1</span><span>、壳聚糖类产品</span></p></td></tr><tr><td valign="top" width="219"><p><span>介入器材</span></p></td><td valign="top" width="240"><p><span>1</span><span>、腔静脉滤器</span></p></td></tr><tr><td valign="top" width="219"><p><span>体外诊断试剂</span></p></td><td valign="top" width="240"><p><span>1</span><span>、血糖试纸</span></p><p><span><br  /></span></p></td></tr></tbody></table><p><br  /></p></section><p><span>来源：<span> 医疗器械经销商联盟</span></span></p><p><span><span><br  /></span></span></p></section><section><p><span>*点击左下角</span><strong>【阅读原文】</strong><span>，即可加入“医疗器械维修工程师群友通讯录”你的世界，由此展开！*</span></p></section><p><p><img src="image/20200927/66b91dba51803cd4fd2a18b800afbccc_3.gif" /></p></p>