Downloadable Software as a Medical Device (SaMD) for calibrating and changing the settings of a cochlear implant based on personalized patient data
- 条目编号
- 009-5839
- 所属类别
- 第9类 科学仪器软件
- 状态
- 有效（A）
- 类型
- 商品
- 生效日期
- 08/27/2020
- 尼斯版本
- 11-2020
- TM5 通用条目
- 否
官方备注
Software as a Medical Device (SaMD) is a downloadable and/or recorded software good used for the diagnosis or treatment of a disease or health condition. SaMD runs on a computer or mobile electronic device, such as a smartphone, when performing the aforementioned functions and is not a component or integral part of medical instruments. Identifications of SaMD must indicate the particular function or purpose of the software in a manner that is sufficient to permit determinations with respect to likelihood of confusion. See TMEP §1402.03(d). SaMD is classified in Class 9 because "recorded and downloadable . . . computer software" is in the Nice Class 9 Heading.
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