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FDA认证注册咨询辅导,美国FDA官方对于医疗器械定义及分类规则划分|FDA2020年年费收取标准

来源:本站 作者:深圳市肯达信企业管理顾问有限公司 陈小姐 18575592846 发布时间:2020-06-23

medical device美国对医疗器械定义:

The FDA defines a medical device as:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

intended 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

intended to affect the structure or any function of the body of man or other animals, and which does not achieve its 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."

FDA将医疗器械定义为:“仪器、装置、工具、机器、装置、植入物、体外试剂或其他类似或相关物品,包括在官方国家处方集、美国药典或其任何补充中得到承认的组成部分或附件,拟用于诊断疾病或其他情况,或用于治疗、缓解、治疗或预防疾病,用于人或其他动物,或              旨在影响人或其他动物身体的结构或任何功能,且不能通过人或其他动物身体内或身体上的化学作用达到其主要预期目的,且不依赖于代谢以实现其任何主要预期目的。”


Medical Device Classification 医疗设备分类

Currently medical devices fall into one of three medical device classifications: Class I, Class II, and Class III.  Class I includes devices with the lowest risk and Class III includes those with the greatest risk. For more information please visit the Classify Your Medical Device page.  In some circumstances devices are unclassified.  For more information review the Medical Device Classification Product Codes Guidance for Industry and FDA Staff. This document also includes information regarding section 513(g) of the Act, which provides a means to obtain the FDA's view regarding the classification and regulatory requirements that may be applicable to a particular device.


目前,医疗器械分为三类:一类、二类和三类。一类包括风险最低的器械,三类包括风险最大的器械。有关详细信息,请访问“对医疗设备进行分类”页面。在某些情况下,设备是未分类的。欲了解更多信息,请查阅医疗器械分类行业和FDA工作人员的产品代码指南。本文件还包括有关该法案第513(g)节的信息,该节提供了一种方法,以获得FDA对可能适用于特定设备的分类和监管要求的意见。


Registration and listing注册和上市

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.  

在美国从事生产和销售用于商业销售的医疗器械的机构必须每年向FDA注册。大多数需要登记的机构也必须列出这些设备以及在这些设备上进行的活动。(美国联邦法规标题21第807部分)。

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