文档介绍：?医疗器械监督管理条例 Evaluation only. Evaluation only. Created with Client Profile . Created with Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Copyright 2004-2011 Aspose Pty Ltd. 医疗器械监督管理条例?第一章总则?第二章医疗器械的管理?第三章医疗器械生产、经营和使用的管理?第四章罚则 Evaluation only. Evaluation only. Created with Client Profile . Created with Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Copyright 2004-2011 Aspose Pty Ltd. ?第一章总则 Evaluation only. Evaluation only. Created with Client Profile . Created with Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Copyright 2004-2011 Aspose Pty Ltd. 第一章总则?第三条本条例所称医疗器械,是指单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品,包括所需要的软件; ?其使用旨在达到下列预期目的:(一)对疾病的预防、诊断、治疗、监护、缓解;(二) 对损伤或者残疾的诊断、治疗、监护、缓解、补偿;(三)对解剖或者生理过程的研究、替代、调节;(四)妊娠控制。 Evaluation only. Evaluation only. Created with Client Profile . Created with Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Copyright 2004-2011 Aspose Pty Ltd. 第一章总则?第五条国家对医疗器械实行分类管理。?第一类是指,通过常规管理足以保证其安全性、有效性的医疗器械。 Evaluation only. Evaluation only. Created with Client Profile . Created with Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Copyright 2004-2011 Aspose Pty Ltd. 第一章总则?第五条国家对医疗器械实行分类管理。?第二类是指,对其安全性、有效性应当加以控制的医疗器械。 Evaluation only. Evaluation only. Created with Client Profile . Created with Client Profile . Copyright 2004-2011 Aspose Pty Ltd. Copyright 2004-2011 Aspose Pty Ltd. 第一章总则?第五条国家对医疗器械实行分类管理。?第三类是指,植入人体;用于支持、维持生命;对人体具有潜在危险,对其安全性、有效性必须严格控制的医疗器械。 Evaluation only. Evaluation only. Created with Client Profile . Created with Client Profile . Copyright 2004-2011 As