January 15, 2018

In line with the rapid development of cloud computing, big data and artificial intelligence, mobile technology has been widely used in medical devices. Recently, China Food and Drug Administration (CFDA) released “Guidelines of Mobile Medical Device Registration." The provisions of this guideline was implemented from its effective date on December 29th, 2017. 

This guideline covers the definition, type, judgment principle and general requirements for registration of the mobile medical devices. CFDA recommends that manufacturers use the guidelines in conjunction with “Guiding Principles for Medical Device Software Registration Technology Review”, “Guidelines of Medical Device Network Security” and other related guidance documents. In addition, according to the definition in the guidelines, mobile medical devices can be divided into three types, "Mobile medical device", "Mobile independent software" and "Mobile medical accessory". Manufacturers may refer to the guideline to find out the appropriate type and submit the corresponding registration documents.

Moreover, CFDA also mentions that the mobile medical devices are the combination of mobile technology and traditional medical devices. CFDA advises manufacturers to consider not only the requirements of traditional medical devices but also the characteristics and risks management of mobile technology, including the network security capabilities, display limits, ambient light, battery capacity limitations, cloud computing services, and other parameters.

Reference:

The Guidelines of The Mobile Medical Device Registration