如何进入美国医疗器械市场.pdf

如何进入美国医疗器械市场？ 如何进入美国医疗器械市场？ 如何申请FDA　510 （k）？ 　 如何申请FDA 510 （k）？ 　 Medical Device Definition Medical Device Definition Medical Device Definition by FDA an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: lrecognized in the official National Formulary, or the United states Pharmacopoeia, or any supplement to them, lintended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or lintended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it`s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. 医疗器械的定义 医疗器械的定义 FDA对医疗器械的定义 　一个仪器、设备、器具、机器、用具、植入物、体外 试剂或校准器，或者其他相似或相关物品，包含零部 件或配件，它是： l 记载于正式的国家处方，或美国药典，或其它附录； l 疾病的诊断、预防、监护、治疗或者缓解，作用于人 类或者其它动物 l 影响人体或其它动物的结构或功能，并且不是通过在 人体或动物体内的化学反应来达到既定预期用途，也 不是依靠产生代谢变化来获得任何其既定预期用途。 医疗器械的分类 医疗器械的分类 医疗器械的分类和法规控制： l Class Ⅰ一般控制 With Exemptions 豁免 Without Exemptions 无豁免 l Class Ⅱ 一般控制和特别控制 With Exemptions 豁免 Without Exemption无豁免 l ClassⅢ 一般控制和PMA认证 医疗器械的分类 医疗器械的分类 l 医疗器械生产商需要获得FDA 的上市前清关　　　　 market clearance l 根据产品等级分类( Ⅰ，Ⅱ或 Ⅲ), 上市的程序可分成三种 1) Class1\11 exemptions (class Ⅰand some class Ⅱ) 2) 上市前通知pre-market notification ［510(k) ］ 3) 上市前认证pre-market approval (PMA) Reference:/cdrh 一般控制General controls? 一般控制General controls? Class Ⅰ—