FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CFDA Spells Out Cybersecurity Requirements

Feb. 10, 2017

Manufacturers who want to register networked medical devices in China need to assess the devices’ cybersecurity, according to new guidance from the China Food and Drug Administration.

Manufacturers should adopt a cybersecurity risk management system that identifies vulnerable devices, any cyber threats that could harm patients, the level of risk, and necessary control measures, CFDA said.

The guidance, supplements the CFDA’s Guidelines for the Review of Medical Device Software Registration Technology, applies to Class II and III medical devices that connect to networks for the purpose of exchanging or storing data, or for remote control.

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