If Medical Device Does Not Have Internet Connections, Is It Not Applicable To The Cybersecurity Requirement?

The applicability of cybersecurity for medical device refers to not only the network connection for electronic data transfer and remote control, but also the use of storage media for electronic date transfer.

For medical devices, although there may be no internet connection, while other data transfer ports or data exchange methods could be used(such as USB, RS232, CD-ROM, etc.), which is also applicable to cybersecurity requirements.

In addition, although some medical devices do not have any network connection or physical ports, they can realize data transaction function on the operating user interface. This is also considered as the situation of electronic data exchange, and therefore cybersecurity requirements are needed.