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Medical Devices / Regulatory Affairs

China Releases Review Guidelines for Mobile Medical Devices

Jan. 16, 2018

China’s Food and Drug Administration released technical review guidelines for mobile medical devices to guide devicemakers in preparing applications for the devices and to help control the risks associated with mobile computing technology.

The technical guidelines are based on China’s National Security Law, CFDA device regulations and information security standards relevant to cloud computing, big data, and mobile terminals, and draw upon FDA guidelines as well as EU and IMDRF documents.

They apply to equipment or software that combines a medical use with a non-invasive mobile computing terminal. Implantable and invasive medical devices are not included in the category.

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