Software as a Medical Device (SaMD), recorded, for use as a medical instrument for {specify nature of procedure, e.g., taking a pulse, listening to internal organs, etc.} 009-5865
已录制的软件即医疗器械（SaMD），用作{具体指明操作性质，例如测脉搏、听诊内脏等}医疗器具
Chinese
已录制的软件即医疗器械（SaMD），用作{具体指明操作性质，例如测脉搏、听诊内脏等}医疗器具
English
Software as a Medical Device (SaMD), recorded, for use as a medical instrument for {specify nature of procedure, e.g., taking a pulse, listening to internal organs, etc.}
Spanish
Software como dispositivo médico (SaMD), grabado, para su uso como instrumento médico para {especificar la naturaleza del procedimiento, por ejemplo, tomar el pulso, escuchar los órganos internos, etc.}
- Term ID
- 009-5865
- Class
- 09
- Type
- Goods
- Status
- Active · added, not since modified (A)
- Effective date
- 2020-08-27
- Version
- 11-2020
Official English notes
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.